Thank you for standing by, and welcome to the Arcutis Biotherapeutics top-line data call. At this time, all participants are on a listen only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star one on your telephone. If you require any further assistance, please press star zero. I would like to turn the call over to you, Eric McIntyre. You may begin.
Thank you, Kevin. Good morning, everyone, and thank you for starting your Mondays off with us. We're incredibly excited here to be with you to discuss our positive top-line results for the STRATUM pivotal phase III study evaluating roflumilast foam as a potential topical treatment for seborrheic dermatitis. Today's webcast and posted presentation can be found under the events and presentations tab of our investor section of our website. Of course, before we begin, I'd like to remind you all that the safe harbor rules govern our remarks today as well as any forward-looking statements that we make during this call. These statements are subject to any risks and uncertainties that could cause actual results to differ materially. With that, I'm extremely pleased to turn the call over to Frank Watanabe, President and CEO. Frank?
Hi. Thanks, Eric, and good morning, everyone. I'm on slide three. Just briefly, we are joined today by Dr. Zoe Draelos who is a leading dermatologist and one of the investigators in the trial, as well as Patrick Burnett, our Chief Medical Officer, and Ken Lock, our Chief Commercial Officer. Turning to slide five, just to remind everyone, we talked at our Investor Day earlier this year, you know, about the fact that 2022 is going to really be a transformational year for Arcutis. We continue to believe that and I think we're delivering on that promise.
As a reminder, we talked about the fact that the topical roflumilast, we believe has a very different clinical profile, and we continue to target three distinct disease states, all with about 2 million patients apiece who are seen by dermatologists in the U.S. and treated topically, so all very large opportunities. As we're talking a little bit more today, our excitement level about the potential for roflumilast in seborrheic dermatitis continues to grow and these results are very confirmatory of that. We're making steady progress on our commercial launch preparations and are very excited about our potential PDUFA date or our PDUFA date and potential approval on July 29.
We think that we've got a very good chance of replicating the success in plaque psoriasis and now seborrheic dermatitis as we read out the atopic dermatitis and scalp psoriasis and body psoriasis trials later this year. On slide number six, again, at the beginning of the year, we talked about four major catalysts coming up for 2022, the first one being seborrheic dermatitis. We told you all about the middle of the year and we're just a little bit early with the delivery to day of those results. We still are expecting approval on the 29th of July from the FDA.
We expect to read out the seborrheic scalp psoriasis and body psoriasis trial right around the end of Q3, beginning of Q4, followed by the two, INTEGUMENT-1 and INTEGUMENT-2 phase III studies in atopic dermatitis before the end of the year. On slide seven, again, just to recap, as we talked about our Investor Day, these are all very large opportunities, psoriasis, atopic dermatitis, and seborrheic dermatitis. Again, I call your attention to seborrheic dermatitis. I think this is an underappreciated opportunity, but there are as many seborrheic dermatitis patients in the dermatologist office receiving topical treatment, as there are psoriasis patients. As Dr. Draelos will talk a little bit more in just a moment, there is very significant unmet need.
We have, you know, a really innovative profile that we think fits well with those needs and we think this represents a really significant opportunity for us and a significant advancement in treatment for doctors and patients. In terms of the clinical profile, I'm just going to recap, nothing, you know, really changed here, but what we've seen is efficacy with topical roflumilast, either the cream or now the foam that's on par with steroid vitamin D combinations. It's a very unusual thing and a very needed thing to have, a non-steroidal that can be used chronically, and anywhere on the body. That's a very significant development. We don't expect any box warnings on our label.
Again, in the study, we have seen very, very favorable local tolerability with none of the burning and stinging, or folliculitis, or contact dermatitis that are associated with some of the other topicals, in the space. We've treated well over 3,500 patients now with roflumilast, and that safety profile and tolerability profile has been consistent throughout all of those studies. With that, I'm going to turn it over to Dr. Draelos to talk a little bit more about seborrheic dermatitis from a clinician's perspective. Dr. Draelos?
Yes. Hello. I'm Zoe Diana Draelos and I am both a clinical and a research dermatologist. I had the opportunity to participate in a variety of roflumilast trials, both in phase II and phase III, and, o f course, I also treat patients, which is why I'm so excited about this new development in dermatology. We do not have any drug that is on label for seborrheic dermatitis at this point in time, even though approximately 10 million individuals in the U.S. are afflicted with this disease. In the past, we had challenges in treating this disease because there was nothing on label, but yet it's a disease that needs treatment. Seborrheic dermatitis has a debilitating itch. That itch leads to scratch, which can cause sores, bleeding, infection.
It also can be a socially debilitating disease because seborrheic dermatitis leads to embarrassment about scratching your scalp in public as well as flaking on clothing. Living with seborrheic dermatitis negatively impacts both patients' health and their quality of life. In the past, our treatments have been somewhat complex and suboptimal. Antifungals are commonly used both in the form of shampoos and topicals, but neither are really highly effective, especially for the itch. Anti-inflammatory agents such as topical corticosteroids are the predominant treatment but the problem is their long-term safety profile is not good. Thus, roflumilast offers an amazing opportunity. It's a very elegant, foam vehicle, nice to use in hairy areas, no sticky creams. It's also highly efficacious, as the phase III pivotal results show. It is able to improve seborrheic dermatitis, and it's on-label, and suitable for all body areas.
Topical roflumilast for me as a clinician represents a significant step forward by expanding the dermatologist's armamentarium. Also, from a patient standpoint, it's a significant step forward because now we have an on-label product for seborrheic dermatitis, but also patients now have something that really works, something that's efficacious, and something that's aesthetic. All of those are very, very important as we advance the treatment of seborrheic dermatitis in dermatology.
Great. Thank you very much, Dr. Draelos. This is Patrick Burnett. I'm the Chief Medical Officer. If you move to slide 12, I'm just going to give a little bit of background on the phase III trial design that we used for STRATUM, and then some of the efficacy and safety results. STRATUM enrolled 457 patients, and they were randomized two to one, our roflumilast foam at the dose of 0.3% applied once daily. And those were compared to patients treated with the vehicle, also treated once daily for an eight-week treatment period. The enrollment allowed patients of moderate and severe seborrheic dermatitis only, so we didn't enroll any mild patients into this trial. That was determined based on Investigator Global Assessment at baseline. We included patients down to the age of nine.
Seborrheic dermatitis onset is associated with puberty so including patients into this, dipping into the highest ages of the pediatric age range, allowed us to really have a comprehensive enrollment that covered the entire spectrum of age range of where patients get seborrheic dermatitis. In addition to that, we treated seb derm not just on the scalp, but also on the face or anywhere on the body where it appeared with the goal of also being able to kind of cover seborrheic dermatitis wherever it appears on the patient. The primary endpoint for this trial was Investigator Global Assessment success at week eight. IGA is a five-point scale, with zero being clear and four being severe.
Patients needed to get to clear or almost clear, that's a zero or one on the IGA, in order to be considered a responder for this trial. We call that an IGA success 'cause patients also had to have at least a two-point improvement, but b ecause we only enrolled moderate and severe patients, by definition, getting to a zero or one meant that you met those IGA success criteria. The primary endpoint was IGA success at week eight. Secondary endpoints included IGA success at weeks two and four, as well as Investigator Global Assessment score of zero at week eight, and I'm showing you those data today. We looked specifically at erythema scaling individually. These are a part of the IGA but those were included as secondary endpoints with separate scales.
The other piece of data that we'll show today is our Worst Itch Numeric Rating Scale or WINRS data, which is how we captured itch in this study. Itch is a key component, as mentioned by Dr. Draelos, of seborrheic dermatitis and can have a significant impact on quality of life. If we move to slide 13, these are the primary endpoint data. Looking specifically at week eight and you can see that with an efficacy rate of 80.1% of patients achieving IGA success on active compared to a vehicle of 59.2 and a p-value of less than 0.0001. Th is was a successful trial demonstrating a robust statistical difference between active and vehicle and also a clinically meaningful efficacy in this study at week eight.
Moving down into earlier time points of week two and week four, you can see already after two weeks of treatment, over 40% of patients met the IGA success criteria, and that bumped all the way up to 73% by week four. We are really excited about these results. They actually exceed our phase II efficacy that we demonstrated previously with the foam and seborrheic dermatitis. This is exactly the same foam product that was used in that phase II study. We think that these results are really going to bring a lot of benefit to patients with seborrheic dermatitis for this investigational product. Moving to slide 14, this is IGA of clear or IGA of zero.
What this means is that these are patients who came in at moderate to severe disease and then made it all the way to clear at some point during the trial. You can see those patients making it to clear by week eight and then, of course, they have to maintain clearance through week eight in order to be considered a responder for this endpoint. Greater than 50% of patients met these criteria so t hat's 50.7% for active and 28.2% for vehicle. Already at week four, just over 1/3 Of patients have made it all the way to an IGA of clear, and that was 16.4% at week two.
This is a really high bar for patients with seborrheic dermatitis because it essentially means that all of the manifestations of their disease on their skin has been cleared by the treatment at that endpoint. You can see this is also supported by p-values that are also similarly low to what we'd seen previously. Moving to slide 15, i tch, as I mentioned, is really the key symptom that drives patients' severity and impact on quality of life in seborrheic dermatitis. At week eight, we had just shy of 64% of patients reaching a WINRS response. This meant that to be included in this endpoint, patients had to have an itch of at least four at baseline coming into the trial, and then over the period of treatment, had to have an improvement of four or greater in that itch response.
This is the assessment of itch, which has been included in other topical products by the FDA in labeling. We captured it in a way that we felt would support labeling for this indication as well. This 64% response in patients was compared to 42% of patients in the vehicle response rate. If you look at earlier time points, we had about a third of patients meeting those criteria at week two and 48% of patients at week four already. This level of response is consistent with these and across other indications, and again shows the benefit not just of treating the appearance of the disease, but also the key symptomatic driver of seborrheic dermatitis. The next two slides cover the safety that was observed in the trial. On slide 16, just a high-level overview.
You can see that the overall adverse event rates were low and balanced between roflumilast and vehicle. We had a single serious adverse event unrelated by the investigator and re ally kind of the key safety outcome that I think captures best the overall tolerability of the product is the discontinuation rate due to adverse event. Here you can see that roflumilast was at 0.7% so only two patients out of over 450 patients discontinued due to an adverse event. Actually, two patients out of 304 on active and three patients on vehicle. Our rate on active is 0.7% versus a 2% rate on vehicle.
Overall, that's a 1.1% for the entire trial and I think really demonstrates the very good tolerability that was observed in this trial. The final safety slide on slide 17 shows all adverse events that occurred with a rate of greater than 1% in any group. You can see the most common adverse event reported was COVID-19, which was balanced between active and vehicle. Similarly for urinary tract infection and nasopharyngitis, those are the top three. Nausea was seen in 1.6% of patients on roflumilast but not reported in vehicle. Application site pain was actually more common in vehicle compared to roflumilast.
This is something we'd seen previously in studies and represents the lack of treatment for vehicle patients because stinging, burning, and pain are a part of this disease state of seborrheic dermatitis. We are very pleased, and w e feel that these safety data are consistent with what we've seen with earlier trials and in other indications, and really sets us for a very nice benefit-risk for the treatment of patients with seborrheic dermatitis for this investigational product. Zoe, Dr. Draelos, I'd like to ask you to comment please on what you think these data mean for patients with seborrheic dermatitis.
I think this is a really important advance forward in the treatment of seborrheic dermatitis. One, extremely high efficacy, which is really amazing. In dermatology, a lot of times many drugs have difficulty separating from vehicle, and here the vehicle is so nice and so excellent that it might provide some aesthetic enhancement. But yet the drug path surpassed the vehicle, and this is excellent efficacy data. Then the second point, of course, is the low side effects. We learn to accept some side effects in drugs. In dermatology, they may sting, they may burn, but here you had very, very excellent safety profile. Then finally, the aesthetics of treatment are critically important especially on the scalp.
Many of our current treatments are creams or oily lotions or alcoholic vehicles that sting when you put them on the scalp and all those are burdens for the patient. Not only do they have seborrheic dermatitis but now they have to have icky, greasy hair because the product's not aesthetic. This foam in which the roflumilast has been placed for seborrheic dermatitis treatment is excellent, does not leave residue, and t hus, patients can really treat themselves, still have their self-confidence restored, and break away from the horrible itching, stinging, burning, and physical disfigurement of seborrheic dermatitis.
All right. Thank you, Dr. Draelos. We'll just move on very quickly to the commercial opportunity, just following along with me on slide 19. Given the profile and exciting data that we just heard about, you know, we really feel that roflumilast foam could be the new standard of care in seborrheic dermatitis. If you walk across here at the bottom, you can see the different attributes. First and foremost, the incredible efficacy that the product demonstrated, imagining, you know, eight out of 10 patients being able to achieve full clinical benefit and a full half of those patients, or 50%, being able to get completely clear. The ability for it to be used on all affected areas of the body and in the case of seborrheic dermatitis, we're seeing manifestations in the scalp, brows, face, and trunk.
Again, and consistent with the profile of topical roflumilast, as we saw in psoriasis, extremely well-tolerated and the ability to be used everywhere. Obviously, the safety and tolerability data that supports potential for chronic use. Again, as Dr. Draelos articulated, the current standard of care really involves, particularly for the moderate to severe patient really involves, you know, topical corticosteroids, which we all know the shortcomings of that. We won't be limited by that aspect in terms of duration of use. Again, the simplicity, the ease of use, the once-daily foam, and the aesthetic benefit is very clear. Last but not least, the dual mechanism of the product itself being both antifungal and anti-inflammatory in nature.
On the next slide, I'll just sort of recap some of the statistics that Frank provided, reminding everyone that, again, the opportunity with respect to seb derm is comparable in size to psoriasis with no current other products being promoted in the space. Starting at the top of the funnel, you can see that 10 million moving down to, you know, 7 million or so being topically treated, 4 million being prescription topically treated by a dermatologist, which is the focus of our commercial strategy. Then at the very bottom, you see the topically treated moderate to severe population, which also coincides specifically with those being treated with topical corticosteroids today. From a patient volume standpoint, we've talked about this before, on average, about 75 patients seen for seborrheic dermatitis in a typical month.
That triangulates approximately with about 80 that we see for psoriasis so very large numbers of patients. This condition is, you know, well-characterized and understood by physicians in terms of the ability to diagnose.
At the very bottom, you see, just in terms of as you move into the moderate to severe population, the urgency and ultimately the treatment rate is extremely high. W ell over 90% of patients who present and are identified with this condition are given treatment of some sort in terms of a prescription. you know, over nine out of 10 patients who have moderate to severe disease do get some kind of prescription therapy. What's not on the slide, but of note is that, we had conducted a survey back in late 2020 when upon the arrival of our phase II data. At that time, you know, this new data has actually improved upon that.
At that time, over 85% of physicians already were indicating the likelihood of either likely or very likely to prescribe this agent so a lot of interest and excitement, enthusiasm around the potential for something in seborrheic dermatitis, which has largely been a very dormant market for some time. Moving on to slide 21, and my last slide here is just to talk a little bit about the patient perspective. As Dr. Draelos articulated, again, the current standard of care have many limitations, including, you know, the limitations in efficacy, safety, tolerability, as well as aesthetic appeal.
What we found actually in a very recent survey we conducted of over 300 patients or 300 patients here, we discovered that, you know, the treatments used or the number of treatments being used to manage one's condition in seborrheic dermatitis was tremendous. On average, you can see nearly six different types of treatments being used by a patient and they're spending well over 30 minutes a day managing their condition. You can see sort of a combination there of prescription therapies over the counter as well as alternative treatments on average, which is quite a bit of burden, frankly, for a patient.
The ability to ultimately potentially transition to a single agent that could manage all of this, reducing, you know, hours to minutes or minutes to seconds in terms of the treatment will be a tremendous advantage to patients. When we surveyed them with a potential of just even the idea of reduction of prescription or treatment burden, well over 90% of patients actually agree that they would more likely stick to the treatment plan if there simply meant reduction of the number of treatments, let alone the enhanced efficacy and safety profile that we provide. On the right, just a quick snippet, a gain, 90% of patients are agreeing that they are very, very interested in trying new treatment options for this condition.
With that, let me just close on slide 22 and open it up to our question and answer portion of the call.
Ladies and gentlemen.
Yeah. Thanks, Ken.
If you have a question or a comment at this time, please press the star, then the one key on your touchtone telephone. If your question has been answered or you wish to move yourself from the queue, please press the pound key. Our first question comes from Seamus Fernandez with Guggenheim.
Great, t hanks. Thanks, guys, and congratulations on the data. Hoping to get a couple of points of color. Just can you talk about how this data, you know, compares on a relative basis versus your phase II results? Looks very consistent to me, but just hoping to get a little bit more color on some of the new endpoints and some of the shorter-term data that looks quite robust, you know, relative to the phase II. Second question is, you know, you guys have done a really impressive job of taking your phase II results and then bringing that forward to strong execution in phase III. How does this, you know, kind of have you thinking about the opportunity in AD?
We continue to get a lot of questions about, you know, the phase II data that didn't hit statistical significance. We know that there was, you know, clear separation between the active and the vehicle in that study so j ust wanted to kind of get your thoughts there. I t seems to me like this is another opportunity to kind of, you know, higher conviction in that regard. Then the last question, can you guys just help us understand where the patient populations actually sit in the reimbursed landscape?
It's our understanding that many elderly are actually impacted by seborrheic dermatitis, but I just wanted to get a bit of a better understanding of the separation, and where the moderate to severe patients actually sit with this condition, and you know, what the reimbursement landscape looks like for seb derm. Thanks so much.
Okay, thanks. Great to talk to you, Seamus. Patrick, maybe you could address Seamus' questions around phase II to phase III and the read-through to atopic dermatitis, and then, Ken, maybe you can address the payer question or the patient question.
Great. Thanks, Frank. Thanks for your question, Seamus. Yeah, so we see these results as really being very consistent with what was demonstrated in phase II. Obviously, we're happy to see the increased efficacy. We went from just around 74% in phase II on IGA success at week eight here to 80.1%. We were sitting right around 40% for vehicle. The vehicle also increased now to 59.2%. T his is a larger study. We had about 300 patients on active treatment here. So obviously numerically increased rates across both active and vehicle, b ut really, I would say very consistent results in this study compared to the earlier trial as well. I'm never going to be disappointed with an increased efficacy going from phase II to phase III.
I think that this study really captures the benefit for patients there. Itch as well at week eight was very similar in the overall amount. We had 65% phase II, I think 64% here, y ou know, as well, the importance of that endpoint we've already talked about with regard to kind of capturing the key symptom for patients. I think that consistency is also helpful for us as we kind of move towards putting together an NDA and getting this hopefully approved to patients and out to patients. With regard to the read-through in atopic dermatitis, you know, obviously, you know, different product. This is a foam versus the cream formulation we're previously using in atopic dermatitis.
Different dose, t his is 0.3% versus 0.05% and 0.15%, and o bviously a different indication there. I think what this really the read-through here for me, the largest is really our ability, and you mentioned it, the ability of our organization to be able to kind of move programs into phase III and successfully execute against that. We've done it with psoriasis and now we've been able to do it with seborrheic dermatitis. With regard to the phase III studies that are ongoing in AD, you know, we remain very, very confident in those. You alluded to the fact, you know, importantly that we hadn't met our primary endpoint in that smaller phase II trial.
Yeah, again, that did have a component of a higher vehicle rate in atopic dermatitis, which similar to seb derm, you know, that is known to be a component of that disease as well. Just like here, you know, we're not looking to try and reduce the vehicle effect because it really is an intrinsic part of that formulation, which Zoe spent some time talking about with regard to our product. I think that's one of the kind of key benefits of our product. We designed the atopic dermatitis phase III studies to really be able to demonstrate a difference between active and vehicle. That meant that we had a sample size of about 650 patients, which are enrolling in each of those phase III studies so about 10x more than what we had in that phase II trial.
That gives us a power of greater than 95% to see the kind of a delta that, y ou know, we think that we have a really well-designed phase III program for AD. We're looking to demonstrate kind of similar success and execution as we move towards the end of the year there.
Okay. Did you want to pick up on it?
Yeah. Let me pick up on, y eah. Let me pick up on the population for a bit, Seamus. With respect to seborrheic dermatitis, you're correct. In terms of the overall presentation and sort of age, this tends to skew a little bit higher into the older populations. Also, the distribution sort of treated within the dermatology setting is a little bit different than psoriasis as well. I think importantly, as you compare to psoriasis, which is at least two-thirds sort of commercially insured patients, that comes down a little bit with respect to Sebderm, and it's more of a maybe a 50/50 kind of mix with respect to commercial and government pay types. Medicare and Medicaid have come into play a little bit more with this condition.
Of course , you know, Medicare being, you know, what it is, and then Medicaid being, you know, both children as well as pregnant women and people over 65 years old, so, y ou know, it's important to be mindful of that. But I think the, you know, the focus on dermatology offices is still 60% of the patients overall are prescription treated by a dermatologist in this case. I think it's, you know, very still very much aligned with sort of our promotional strategy.
Kevin, maybe next question.
The next question comes from Ken Cacciatore with Cowen and Company.
Hey, team, c ongratulations on this data. Dr. Draelos, thanks for your presentation. This might surprise you, but in the investment community, we know a lot less about seb derm. I was just wondering if you can further bring to life kind of the day-to-day in your practice and kind of help us understand in terms of patient flow. Is it kind of one-to-one, meaning psoriasis patients to seb derm patients? Any kind of qualitative comparisons you can give us in understanding the treatment burden and kind of what's in your office. Also just wondering, obviously, there was a high placebo effect. Do you look at just the absolute? Do you care really much about the difference, or is it the absolute that's, you know, most interesting to you?
Lastly, Frank, I'd be remiss if I didn't ask, you touched a little bit on ARQ-151, if you want to comment at all about the ongoing discussions with the FDA in psoriasis. Thanks.
Well, I certainly can answer the questions about the seborrheic dermatitis patient and the vehicle effect. You know what's really interesting in dermatology is many times companies make their vehicle as awful as possible because the worse your vehicle is, the easier it's going to be to separate your vehicle plus your active versus your vehicle. While that approach is very useful for getting through the FDA, a horrible vehicle will perform horribly, and your active doesn't have to be as good. When you enter the marketplace, that actually backfires on you because a horrible vehicle with a drug mixed into it is still a horrible drug because the patient doesn't want to use it. It stings, it itches, it burns. A really good example of that would be Eucrisa or crisaborole. The boron derivative, excellent drug, i t was put in a horrible vehicle.
It stings and burns when you put it on your skin. The drug has underperformed. Here, with roflumilast and the excellent formulation capabilities that they have at Arcutis, they took the risk of making a superb vehicle, and the vehicle is superb. What does that mean? That means you're going to get a higher vehicle effect. What does that mean? That means that your drug has to perform even better, so your drug plus vehicle splits from vehicle, and so you can get a positive phase III trial and FDA approval. The current approval system really encourages horrible vehicles. Here, Arcutis made an excellent vehicle. This means that people are going to want to use this product. They're going to want to purchase it. You're going to get excellent results, but you're going to get a little bit higher vehicle effect and t hose two things go hand in hand.
I really think and applaud Arcutis for taking that risk, willing to make a great vehicle for an excellent drug. To answer your question about the seborrheic dermatitis patient, I actually, in my practice, see more seborrheic dermatitis patients than I do psoriasis patients. I think seborrheic dermatitis is kind of an understated, almost taboo kind of disease, because people don't want to admit that they have horrible itching of their scalp. Somehow, either through the media or personal perception, people feel that if they have flaking on their clothing, they have to scratch in public, t hat's just not socially acceptable. Some of that might have been a lot of messaging that was put forth quite successfully by Procter & Gamble in their Head & Shoulders campaign many years ago. When people come in, a lot of times seborrheic dermatitis is kind of an afterthought.
I also think a lot of patients with seborrheic dermatitis don't come to the dermatologist because we haven't had anything good to give them. We tell them, "Okay, use a tar shampoo." well, then you smell like a road, or w e tell them to use an antifungal shampoo, and then your hair is real wiry, and it takes the color out of your hair, if you happen to have dyed hair. A lot of people don't get treatment because they feel it's not worth their time or they're not willing to use the treatment. I think having an elegant, efficacious treatment is going to draw a lot of closet seborrheic dermatitis patients into the dermatologist's office. Furthermore, I think seborrheic dermatitis is an underappreciated disease in terms of the burden of disease.
It takes about 45 minutes of scratching to remove the entire cuticle off your hair. That's the protective layer. Once you remove it, the hair breaks. Many people complain of hair loss, worried that they're losing their hair, especially men think that they have male pattern baldness. W hat they really have is seborrheic dermatitis and the hair is just breaking off from the scratching. A lot of seborrheic dermatitis is misdiagnosed by both the patient and the non-dermatologist. Dermatologists can step in here now with a highly efficacious drug, and then people don't lay awake scratching all night. They're not socially embarrassed because they have to scratch during an office meeting, y ou know, their hair can still look wonderful.
They can still do all the various fashionable perming, waving, coloring, combing, cutting that they want because the roflumilast foam won't interact with any of those cosmetic alterations to the hair. This is really, for me, a game changer, k ind of like the biologics were in psoriasis, they were a huge game changer. Now we could control psoriasis without icky, sticky creams. The roflumilast foam, now we can control seborrheic dermatitis without itchy, sticky creams.
Thanks, Dr. Draelos. Yeah. Then just with regard to the question about the FDA, the company's policy is not to comment on regulatory reviews while they're ongoing. I would just say that we continue to be very confident in the approvability of roflumilast cream in plaque psoriasis, and we look forward to hearing from the FDA on the 20th of July.
Great. Thanks so much.
Our next question comes from Louise Chen with Cantor.
Hi. Thanks for taking my questions and congratulations on the great data. I had a couple questions for you. First question is, how do you plan to build out the seborrheic dermatitis market? What gives you confidence that you can successfully do this since it's a new market here? Second, why do you think there hasn't been more innovation in seborrheic dermatitis? Last question I have for you is, if the positive data today have any read-throughs to the other products in your pipeline. Thank you.
Thanks, Louise. Maybe I'll take your second question, and then I'll ask Ken to comment on the first, and Patrick to read or to discuss briefly your third question. You know, I think the lack of innovation, it's a good question, and I don't think we have a particularly good answer. I would just say, you know, if you look at the topical space in general, you know, the most recent drug just recently approved in plaque psoriasis was the first novel topical in psoriasis in 26 years, 1 996 was the last time prior to the recent approval. Atopic dermatitis has seen two in over two decades.
There's just generally a real lack of innovation in topicals. I think also, there's some real similarities between, I think, where atopic dermatitis was, say, 10 years ago prior to the approval of drugs like Eucrisa and Dupixent and where seborrheic dermatitis is today. We think there's going to be a very significant increase in interest by physicians, patients, and pharmaceutical companies going forward as people realize just how large and unsatisfied this market has been. Ken, you want to talk a little, excuse me, about the market?
Yeah, certainly. Hey, good morning, Louise. I just wanted to talk about the market. You know, this is a new market, but it's not. Meaning that, you know, I think the people understand what seborrheic dermatitis is, specifically physicians, and they've been treating this for a very, very long time, you know, with the older standard of care, you know, antifungal corticosteroids, sort of what's been available to them. I think the so-called, you know, gap in terms of market, I think, really lies in terms of patient education and really helping them understand, you know, that, you know, first of all, I think separating the idea that, you know, this is just your sort of garden variety dandruff when, in fact, it is not.
Secondly, I think the current amount of education around this condition is quite limited. As I mentioned earlier, if you were to kind of Google seborrheic dermatitis, you're not going to find much information on this, frankly. I think really presenting a good suite of education to patients and simply making them aware of something brand new and exciting that's actually highly efficacious, I think will be sort of part and parcel to our strategy here. The good news is, again, it's not a new condition, and, you know, we're not needing to educate anybody on how to do something that they're not already familiar with, that is treating the condition.
Again, really identifying it, and, you know, what we found in addition to kind of the overall patient interest is that oftentimes it takes a little bit longer than, you know, like takes a little bit of time to get the positive diagnosis at the dermatologist, y ou know, recognizing the symptoms early and ultimately finding one's way to the dermatologist will be key for us. There are already like you said you know 2-plus million patients you know getting therapy today, specifically topical corticosteroids for seb derm. I think that is obviously a very rich, you know, kind of pool of patients to tap into from the start.
Patrick, do you want to maybe opine on implications for the remainder of our pipeline?
Yeah, absolutely. W e have two key readouts coming the rest of this year. Scalp psoriasis, as Frank mentioned, Q3, Q4, and then atopic dermatitis. I would say the read-through of these data, this being our first phase III study that we've conducted with the foam, you know, has clear implications for scalp psoriasis. We had really excellent phase II data in both seb derm and scalp psoriasis. Now we've been able to kind of check the box on the first one here at seborrheic dermatitis today. We think our ability too, for the product to deliver excellent phase III results has now been shown for foam as well as the team to be able to execute another phase III program really has some nice read-through for scalp psoriasis.
With regard to atopic dermatitis, I touched on that one a little bit better. For me there, it's really about, again, the, you know, the ability of this organization to kind of construct, execute phase III studies, and bring them successfully forward with data so that we can move into getting approval for some of the investigational products.
Thank you.
Our next question comes from Chris Shibutani with Goldman Sachs.
Hi, this is Steven in for Chris. Congratulations on the data. Maybe one on the clinical and one on commercial, w as curious if you did any subgroup analyses for patients with either face or scalp involvement or moderate versus severe disease. Then, commercially, are the dermatologists that you plan on targeting for plaque psoriasis the same doctors that you'd be targeting for seb derm indication?
Sure. Patrick, can you maybe take the first, and Ken, the second question?
Yeah. Hi, Chris. Thanks for your question. This is what we have right now in front of us is just the top-line data for this study. As we get the full dataset coming in, we also will move to bring, you know, additional abstracts and publications on these data out that will include those subgroup analyses. I think the ones that you identify with regard to different body locations as well as different severity are really interesting ones that we're going to definitely want to address. I would say kind of watch the space. We'll definitely be bringing that out as quickly as we can get it.
Yes. With respect to the commercial sort of targets question, Steven, I think it is the same subset, meaning that you know we across the four conditions that we seek you know to address with topical roflumilast, there's a very high crossover. You know, this is medical dermatology, and you know whether you're talking about seb derm, AD, you know scalp.
Plaque psoriasis.
Yeah, plaque psoriasis. This is all the same, you know, universe of things that, you know, key medical dermatologists see. It would likely be, you know, the same physicians. I think the one caveat, as I mentioned earlier, was with respect to kind of the setting in which many of these patients present, and are treated. In this case, there's a little bit more of sort of outside of dermatology component ever so slightly, you know, about the 60/40 ratio. There are a few patients outside, you know, in primary care offices also, getting therapy. As with respect to the derms that we're thinking about, absolutely, you know, the same subset, same group.
Perfect. Thank you very much.
Yep. Our next question comes from Vikram Purohit with Morgan Stanley.
Great. Good morning. Thanks for taking my question. I had one for Dr. Draelos. We were just curious to learn a bit more about how you think roflumilast foam could be used in the real-world setting, assuming approval, particularly when it comes to which areas of the body you think the foam would be best used for, and how you think your patients might evaluate which treatment option, whether it's the foam, whether it's antifungals, whether it's topical corticosteroids, which to use across different areas of the body, and what you think a day of treatment could look like for one of your typical patients now that the foam could be available.
That's an excellent question. Well, seborrheic dermatitis doesn't just affect the scalp. We focused on the scalp, but it's very common in the eyebrows. It's very common around the corners of the nose. It's very common in the beard area, also the corners of the mouth. It also can occur in the armpits. It can occur on the central chest. It can occur in the groin area. Basically, seborrheic dermatitis occurs in areas that are sebum rich, which is the oil the body produces, and also sweat rich. The treatment of seborrheic dermatitis typically involves moist areas of the body, a foam is ideally suited for that. It typically also involves hairy areas of the body, and the foam is ideal for that.
You don't get very good results when you use cream in those areas because they tend to stick on the hair, and they tend to hold moisture, which can cause other skin issues. The foam vehicle is really ideal for all body and scalp and face treatment areas of seborrheic dermatitis. One nice thing about this medication is that you don't have to use it multiple times a day. You know, you can apply it. The other thing that's very easy is foams are very easy to apply and spread. Creams usually take more rubbing for a longer period of time with greater force. The foam just can be spread very easily. Elderly individuals that have seborrheic dermatitis wouldn't have any problems with application of the product.
I think patients would find that the application of the foam is aesthetically pleasing to them. Instead of having a horrible disease with a horrible treatment, they'll find that they get disease control with an excellent treatment. In the clinical studies that I conducted, resolution of seborrheic dermatitis occurred very quickly. It was very easy for me to go down the row of people enrolled in the study and say, "Oh, you got the active, you didn't, you got the active, you didn't." Because we saw reduction in redness, reduction in evidence of scratching, and reduction in flaking within four weeks of initiation of treatment. That is one of the problems with the antifungals currently. They take a long time to work, t he corticosteroids, of course.
Seborrheic dermatitis is a disease that can come and go depending upon the state of health of the individual. A lot of times people do need to continue treatment on and off for various periods of time. Corticosteroids don't lend themselves to that type of treatment but there are no such issues with topical roflumilast. This is a treatment that could be used not only for acute disease, which results in like four weeks, but also on and off as the patient needed treatment over the course of a lifetime.
Kevin, next question, please.
Great. Thank you.
All right. Our next question comes from Uy Ear with Mizuho.
Hi, guys, congrats on the data. Just a few questions from me, t he first question is, what else do you need to have in order to file the NDA in the first half of next year? A second question is, you know, now that you've seen pricing for Opzelura and for the Dermavant product, how does this change your thinking on pricing with your own products? For Dr. Draelos, just kind of curious how you see the frequency of use for roflumilast foam in seb derm? That is, are you expecting your patients to use this on a continuous basis o r if it's on an intermittent basis, like, how many tubes do you think they'll go through on an annual basis? Thanks.
Maybe we'll start out with Dr. Draelos, and then Patrick, if you could address the NDA and Ken, you could touch on pricing.
Yes. There is a wide range in the severity of seborrheic dermatitis, and seborrheic dermatitis is linked to the immune status of the patient. Some people will treat their seborrheic dermatitis maybe for a month, maybe 3x a year. As you get older and the immune system begins to fail, seborrheic dermatitis becomes more common and it also becomes more persistent. I would see patients using roflumilast foam continuously, which can be done safely now in a more mature population. Remember that seborrheic dermatitis also occurs in babies. I mean, it's called cradle cap, but it's seborrheic dermatitis, especially when it gets severe. In that situation, a child might use this product for a month or so. As you get older, the use will increase.
I would anticipate that patients would want to keep a tube of roflumilast cream and foam when they both become available for a variety of diseases in their medicine chest consistently. The use of the foam, I would anticipate that depending upon the body surface area involved, people would probably go through a can of roflumilast foam probably every two to three months. Possibly every month if they had armpit, central chest and groin involvement.
Thanks. Patrick?
Yeah. Thanks for the question, Uy. These data really represent kind of the last major chunk of information that we're really looking for for to be able to get started on the NDA. My team and others will kind of pivot within the organization to start putting this together now to meet that deadline of getting our submission out in the first half of next year.
Great and then Ken?
Yes, yes. Good morning, Uy. With respect to pricing, yes, we've seen now, I think, you know, two key price points with respect to Opzelura and now VTAMA. Both of those products have taken sort of the highest respective price point in the class for their respective conditions. I would say fundamentally, our philosophy still doesn't change. I think we mentioned this at our Investor Day, that sort of irrespective of what our competitors are pricing at, I think we focus, you know, w e place a premium on high quality access, which is actually not specifically just coverage.
Its more about quality of that coverage itself and how many hurdles and step-throughs and prior authorizations, you know, might a physician or a physician office have to do to get to the therapy. We still believe that our sort of more modest pricing will lead to more simplicity and ease of achieving, you know, getting the prescription itself.
Speaking about, you know, when we think about, you know, Opzelura, which now has had some time under its belt, while we're seeing sort of " access" in terms of coverage, the number of steps, you know, double, triple step edits, a couple of prior authorizations, I don't believe that actually aligns with the way that physicians want to use topicals specifically. I t remains to be seen ultimately, you know, how that plays out for the VTAMA product.
In the case of seborrheic dermatitis, if we're talking about that specifically, you know, I think we aim to keep the whatever price we choose for psoriasis, we are likely to price similarly in that same range, you know, being cautious not to sort of decouple, I think, the core pricing between the cream and foam. Also importantly, as mentioned earlier, because of the composition of the patient types and their reimbursement status or type of insurance, it's also very important to be, you know, a little bit more conservative there to make sure that more patients can access those therapies.
Okay. Thank you.
Our next question comes from Greg Fraser with Truist Securities.
Good morning. Thanks for taking the questions and congrats on the results. I was hoping you could comment more on the itch results to help put the improvement there into context. What were the baseline itch scores? Did the responders have little to no itching by week eight? Just any additional color on the itch results would be helpful. Thank you.
Sure. Patrick, thanks for the question, Greg. Patrick, do you want to take that one?
Yeah. Thanks for the question, Greg. What we'll do is, you know, I think we're going to go continue to do some more analyses on these, and I think that will help answer kind of your question with regard to, you know, where patients got to with itch on that 10-point scale. We looked at this Worst Itch Numeric Rating Scale responder analysis, which, as I described, included patients coming in with a four and then having a four-point or greater improvement. In order to look at that, we would need to do a kind of subgroup analysis and then also look at patients getting to some of the lower itch scores to comment specifically on that.
I think just kind of stepping back and looking at the analysis that we do have, you know, this is the one that the FDA has determined to really be conducted in patients who have a clinically meaningful level of itch coming in, so at baseline, they have a four, y ou know, in trials like this, you know, we typically see averages in the five to six range for patients with this condition. Then in order to be considered a responder, you have to have, as I mentioned, a four or greater improvement.
T hat kind of setting by the FDA of this type of analysis to be potentially included in labeling required a lot of back and forth and also discussion with patients in order to elucidate exactly where the clinical meaningfulness of baseline as well as improvement sits so that we could be confident that when we're kind of communicating with patients that they would be in this response group, that it would be a benefit that they would be able to observe themselves. We feel that this is a good way to look at the data, but we will bring additional cuts of it to abstracts and publications as well.
We've done that historically by focusing on itch in some of our earlier trials and other indications, and we plan to do the same here.
Got it. One more. What percentage of the seb derm patients have involvement on body surface area up to 20%? Is an indication with that language based on the phase III design? I s that something that you expect in the label? Thank you.
Yeah. The eligibility criteria of up to 20% really is very, very inclusive. You know, you know, typically you see body surface area percentages in 3% for both mean and median in this indication, j ust given the distribution, which we've talked about earlier, you know, primarily on the scalp and face, but then also, you know, touching on some of these other areas, a patient with body surface area greater than 5% or 6% is really pretty unusual for seborrheic dermatitis. Your typical patient, again, is going to be significantly lower than that.
I think that the inclusion in the label will be focused really on more having a broad label that would be inclusive of patients age nine and above, and then also with regard to severity of moderate to severe. We wouldn't anticipate necessarily having that eligibility criteria spelled out in the label, but it would be reflected in the breadth of the label itself.
Got it. Thanks so much.
I'm not showing any further questions at this time. I'd like to turn the call over to Frank for any closing remarks.
Okay. Well, thank you, and I'll just wrap up by thanking everyone for making the time to join us for the call today, and I hope everyone shares our enthusiasm for the data. I appreciate the questions, and we look forward to talking to you all again very soon. Thanks.
Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and h ave a wonderful day.