Ladies and gentlemen, welcome to the phase II top-line distal ulcerative colitis conference call and live webcast. I am Sandra, the conference call operator. I would like to remind you that all participants have been placed in listen-only mode and the conference is being recorded. The presentation will be followed by a Q & A session. You can register for questions at any time by pressing Star and One on your telephone. For operator assistance, please press Star and Zero. The conference must not be recorded for publication or broadcast. At this time, it is my pleasure to hand over to Giovanni Di Napoli, CEO. Please go ahead, sir.
Thank you. Thank you very much and good afternoon, everyone, and thank you for joining us this afternoon. UC is clearly a home ground for us at Cosmo. Our MMX technology is behind Lialda, one of the world's leading mesalamine treatments, and then also Uceris. We have spent two decades building leadership in gastroenterology. Today we take the next step. This morning we have reported the phase II results for our drug, topically acting gel in distal ulcerative colitis. That delivers an antibiotic directly where the disease is located, and it could become the first antibiotic in this indication.
In this phase II study, 45% of patients reached clinical remission versus 18% on placebo. Today, to take you through the results of the study, I am joined by Luigi Longo, our Chief Scientific Officer, who will present the data. Also we have the honor to have two of the leading voices in IBD, Professor David Rubin of the University of Chicago and Professor Simon Travis of the University of Oxford, who will put the results in clinical context. I will close the meeting with a few next steps and then before we open to the Q & A. I hand it over now to Luigi for the presentation. Thank you.
Thank you so much, Giovanni. Thanks to all of the people attending our call. We are honored to present you this program as well as the results that we have achieved so far. Ulcerative colitis is a chronic inflammatory bowel disease that affects the lining of the colon. The patients typically experience a lifelong pattern of periods of remissions interrupted by flares, requiring long-term disease management. This disease is significantly affecting their daily routines, well-being, and overall quality of life. During active disease, the common symptoms include rectal bleeding, diarrhea, urgency, and abdominal discomfort, and this significantly affects daily routines as well as the day-to-day function. At diagnosis, it is estimated that about 70% of the patients present with a distal involvement, meaning the inflammation is localized in the rectum alone, and this is called ulcerative proctitis, or extends into the left side of the colon, known as distality.
These locations are particularly relevant because they are closely associated with rectal symptoms that can be difficult for patients to manage. The key point is that urgency or rectal symptoms remain the major drivers of patient burden and treatment dissatisfaction. Despite the high prevalence, proctitis has historically received less attention, highlighting a meaningful opportunity to better address the needs of this patient population. UC has become a global disease, affecting an estimated 5 million people worldwide. From this, approximately 3.5 million are living with distal disease, including proctitis, with around 2.54 million in the U.S. and Europe alone. This means that disease affecting the rectum and left side of the colon represents a large population of the overall UC patients. Taken together, these figures reinforce the scale of the unmet need. Millions of patients are managing symptoms such as urgency, rectal bleeding, diarrhea, and discomfort.
Yet distal disease, in particular proctitis, has historically received less focus attention. This creates meaningful opportunities for therapies designed to address the specific burden of these patients. Although U.S. and European guidelines recommend topical therapies as first-line treatments of this subset of patients, current approaches still leave important gaps. First, there has been little innovation in this field over the last years, with most recently approved therapies being systemic, not localized and immunosuppressive. Second, not all patients respond well to initial topical therapy. Some remain symptomatic, while others achieve only partial control and continue symptoms and disruption that affect daily life. Third, the practical burden of current rectal therapies can limit their effectiveness in real world. Challenges with retention and adherence can make sustained use difficult. Where first-line treatment is insufficient, escalation may require rectal or systemic corticosteroids as well as more advanced immunosuppressive systemic therapies.
These options can introduce additional treatment complexity and potential safety considerations. Finally, patients with ulcerative proctitis have often been excluded from the phase III clinical trials. As a result, treatment decisions are made with a more limited evidence base than for the overall UC population. This despite the fact that this population accounts for about 40% of the population. Overall, this underscores a clear need for more effective, practical, and evidence-based treatment options tailored to patients with such distal disease. Cosmo designed rifamycin topically acting gel to address several of the key gaps in the current treatment paradigm for distal UC and ulcerative proctitis. First, rifamycin TAG is built around the novel multi-target mechanism of action with the goal of addressing the complex inflammatory processes that drive disease activity and persistent symptoms.
Secondly, it uses an innovative gel formulation optimized for distal delivery, where effective practical topical treatment may offer a more targeted approach. Third, the program is supported by a rigorous phase II trial designed according to the FDA guidelines on UC. Finally, the product is underpinned by a proprietary formulation and IP extending beyond 2044. Together, these attributes position our rifamycin topically acting gel as a differentiating potential option for this large group of patients. To understand the rationale for our therapy, it is important to recognize that ulcerative colitis is driven by several interconnected processes rather than a single pathway. A central feature is the imbalance in the gut microbiome, the gut bacteria. This altered bacterial environment can contribute to ongoing immune activation and subsequent inflammation. At the same time, patients with UC experience dysregulation of immune responses, which sustain inflammation activity in the colon mucosa.
Another important factor is impaired intestinal barrier function. When the epithelial barrier becomes more permeable, bacterial products as well as other waste substances can cross into the tissue, amplifying the inflammatory cycle. Environmental factors and genetic predisposition also influence risk and severity. rifamycin topically acting gel is designed to potentially address the first three factors. Thanks to the pharmacological properties of the active substance, an antibiotic with anti-inflammatory properties, and also the pharmaceutical characteristics of our proprietary formulation that we will see in the next couple of slides. We will now see what makes rifamycin TAG an innovative treatment of the disease. As the video illustrates, currently available mesalamine enemas are formulated as liquid suspensions. Importantly, they remain liquid at body temperature rather than transitioning into a more structured or adherent formulation after administration.
Due to this, the product may not remain in place effectively and can lead to leakage after administration, which can be inconvenient for patients and may negatively affect the overall treatment experience. There is also a tolerability consideration. These commercial formulations are acidic, and when administered onto an already inflamed mucosal surface, that acidity may contribute to unpleasant sensations and local discomfort. Taken together, all these represent important limitations of current rectal treatment options. In contrast to conventional liquid rectal formulation, our proprietary rifamycin 1% topically acting gel has been designed specifically to improve the patient experience, and we will see in the data how we achieved this goal. As the video is showing, at room temperature, the formulation is a liquid, allowing for convenient administration. Once administered and exposed to body temperature, it turns into a gel.
This transformation is of extreme importance because the gel has high adhesiveness and is designed to remain in contact with the mucosa. As we will see in the data, this may reduce the risk of leakage and the immediate need to use the toilet after administration. The formulation also has a physiological neutral pH. This is intended to improve tolerability, particularly when the mucosa is already inflamed and sensitive. Together, all these characteristics are designed to solve practical issues that can limit confidence in the current therapies and make our treatment more practical and better tolerated, supporting improved long-term adherence to the therapy. Now, let's take a look at this diagram depicting the study design.
This was a phase II trial designed to evaluate rifamycin 1% topically acting gel in patients with mild to moderate ulcerative colitis using a placebo-controlled design and the FDA standard primary endpoint to the clinical remission. Patients first entered a screening period. Only those with a confirmed inflammation in the target area, distal colon, so the left side of the colon and rectum, after endoscopy plus histology, would proceed to randomization. Eligible patients were then randomized in a 2: 1 ratio to receive either rifamycin TAG or placebo. The treatment period lasted six weeks, during which patients recorded their symptoms daily and finally underwent end of treatment endoscopy to evaluate the primary endpoint. This scope was then followed by an eight-week follow-up period.
The primary objective was to assess the efficacy of rifamycin TAG versus placebo in inducing clinical remission after six weeks of treatment, the endpoint as per FDA guidance. The study also evaluated clinically relevant secondary outcomes, including safety and tolerability, as well as patient satisfaction. Now, before we start reviewing the study results, it is important to clarify what the clinical remission means. This is a demanding FDA alignment point. Clinical remission requires a total Mayo score of two or less. Mayo score is the disease severity scale utilized to grade UC in all the clinical programs of new drug products. This overall score of two is achieved only when all of the following three individual criteria are met at the same time. First, stool frequency must be almost normalized with a score of one or less. Second, rectal bleeding must be completely absent with a score of zero.
Even minimal bleeding results in failure to meet the primary endpoint. Finally, the endoscopic appearance of the mucosa must be nearly free of disease. The endoscopy score must be one or less, and the score of one is acceptable only when there is no mucosal friability. That is, the appearance of the inflamed mucosa. This endpoint integrates both the patient experience, the symptoms, as well an objective assessment of mucosal status. Failure of one of these components means the patient is not considered to be in clinical remission. This high bar is important in the context of interpreting the phase II efficacy results. Now, let's take a look at the patient demography in our trial. Looking at the baseline characteristics, the two arms were very well balanced. There were no measured differences in terms of sex or mean age.
As regards to disease extent, the population was well balanced across the two arms. Approximately 2/3 of patients had distal ulcerative colitis, while roughly 1/3 had ulcerative proctitis. Importantly, most patients remained on concomitant oral UC therapy, primarily oral mesalamine. Turning to the primary endpoint, rifamycin TAG demonstrated a statistically significant improvement in clinical remission at week six compared to placebo. Clinical remission was achieved by 46.2% of patients receiving the active treatment versus 14.3% in the patients receiving placebo. This represents an absolute difference of 31.9 percentages with a P value of 0.019%, meaning the study met the pre-specified primary endpoint. When we exclude the mildest patient, the patient with minor symptom as well as less disease severity at endoscopy, and focus only on those patients with a moderate baseline disease activity, the difference between treatment arm and placebo widens further.
In this subset, clinical remission at week six was achieved by 48.3% of patients receiving our rifamycin TAG compared to 11.1% on placebo, an absolute difference of 37.2%. This suggests that the treatment effect is particularly compelling in patients with greater baseline disease activity and burden. Beyond the clinical efficacy, it is also important to look at the overall experience reported by patients by answering specific questions on a questionnaire. This really marks the difference in our point of view between the previous conventional therapies and our therapy. In fact, as you can see by the numbers here, patients reported a positive overall experience with our product. Compared to placebo, more patients described the treatment as satisfying, easy to administer, and easy to retain upon administration. The most notable practical difference was about dosing. About 85% of patients receiving the gel reported no immediate need to use the toilet.
This is an important limitation of most of the conventional liquid rectal therapies. Tolerability was also favorable. Most patients reported no burning sensation, no itching, and no pain after administration, and this translates in an outstanding 82% of patients who expressed the willingness to reuse our treatment. Overall, these findings support the formulation's goal of delivering not only clinical benefit, but also a more practical and acceptable treatment experience for patients. Turning to safety, treatment-emergent adverse events considered to be related to the treatment were frequent.
In the rifamycin group, events related to the treatment were reported in four patients or 7.8%, compared to one patient or 4.2% in the placebo group. The individual events were generally isolated, low in frequency, and not serious in severity. Overall, the safety profile was consistent with a locally acting treatment, with a few treatment-related adverse events observed and no evident clustering of specific tolerability concerns. I now turn the speech to Giovanni for closing remarks.
Well, Luigi, thank you so much. These are clearly outstanding results. From efficacy point of view and also safety point of view, I think the primary point of this phase II trial has been met, which was the goal to move this asset forward into phase III. We clearly have a very well-differentiated novel mechanism of action. You saw the video from the presentation that it's a very different experience also the patients have perceived out of this drug. The gel, I think, gives a lot of upside in term of tolerability, but also efficacy as a local treatment. As I said, and Luigi shared, we had a positive safety profile. No surprises there.
What I want to point out is that this is a large underserved population. I think what I would love to do is to now ask a few questions through Luigi to our two key opinion leaders and get their feedback on both the population that could benefit out of this drug, but also the novel treatment and therapy that we have developed at Cosmo. Luigi, maybe you want to involve both Professor Travis and Professor Rubin, then we can get their feedback as well.
Yeah. Let's start with the first question. Professor Travis, UC and ulcerative proctitis represent a large underserved population. In your opinion, where could rifamycin TAG fit in the current treatment landscape, and how significant is the opportunity?
Thank you, Luigi. Thank you, Giovanni. I think it's a real opportunity in that it will appeal to both patients and physicians. Physicians will like the novel mechanism of action and the fact that it can be added on to any existing therapy, which includes the advanced therapies, because it doesn't add to immunosuppression. Patients will like the tolerability, and the fact that it goes in as a liquid, becomes a gel, is just extremely appropriate for a topical agent, because solids are better tolerated than foam, better tolerated than liquids. This is the first gel, and it works. Could it become first-line therapy? That depends on the phase III results, but certainly, it will find a place in the current treatment of a neglected area of ulcerative colitis.
Thank you, Professor Travis. Now a question for Professor Rubin. What are the key features that differentiate rifamycin TAG from existing treatment options, and how may its local active mechanism and novel gel formulation support clinical adoption in distal disease and ulcerative proctitis?
Well, thanks, Luigi and Giovanni. I think that this is a significant advance for our patients, and I'm very enthusiastic. Rifamycin is not an immune suppressant as far as we know. It may have anti-inflammatory properties unique to that particular therapy and mechanism, but obviously we know it better as an antimicrobial agent, reducing bacterial loads. In delivery to the rectum with this unique gel and its adherence to the mucosa, the lining of the rectum, I think that it may be providing a more direct effect to reduce what we think might be stimulating that immune response to cause some of these chronic problems. So it's a very unique concept and in our world, when something works, we're delighted, and then we want to understand it better. But the rationale here makes good sense to us.
Very enthusiastic, and I think patients will be very receptive, not just to the gel, which as Professor Travis already mentioned, will be well received. But I think they understand conceptually the principle that if we reduce some of the bacteria in your bowel, it might reduce the inflammation. Then, of course, when it works, they're going to be very happy as well.
Great. Thank you. Thank you so much, both Professor Travis and Professor Rubin. I would love to open to Q & A. I think I can ask the operator to open up the line for those who want to ask a question, and please let's go ahead.
Thank you, sir. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on the telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to disable the loudspeaker mode and eventually turn off the volume of the webcast while asking a question. Webcast viewers may submit their questions in writing by the relative field. Anyone who has a question may press star and one at this time. Our first question comes from Chiara Montironi from Van Lanschot Kempen. Please go ahead.
Hi, this is Sandrine for Chiara. Congratulations on the good results, and thank you for taking our questions. First, a bit from a modeling perspective. Can you give us any indication on pricing expectations for a drug in mild to moderate UC? Any benchmark that we should keep in mind? Secondly, you said that the Mayo scores gives a strict benchmark for the results. How would that compare, do you feel, to the previous drugs that have been studied in this field? Any remarks you could give us of benchmarking this drug to the field?
It was very hard to hear. Sorry, I didn't want to interrupt you, but
It's okay. I could hear her.
Yeah, please.
Why don't I answer the benchmark part of the question?
Yeah, please. Go ahead.
She asked about pricing, so I will leave that part to you guys.
Yeah.
In terms of benchmarking, Simon can add his wisdom. This is the best results I have seen of a topical therapy. 47% remission of those symptoms is a remarkable result. That is saying one in two patients essentially are going to respond and feel better with this. That is a really confident number for us, and it is better than other topical therapies. In comparison to some of our systemic therapies, the advanced drugs that we talked a little bit about here, this is better than those when you look at remission rates. Of course, we want to see more to understand, but very enthusiastic results with this phase II trial. Simon, do you want to add?
Yeah. I completely agree. Of course, there are very few trials in mild to moderately active disease to use it as a benchmark. Because all the advanced therapies are focused on moderate to severe disease. The key there is what the placebo response was. The clinical remission, that is clinical symptom control and endoscopic remission, you have got 11% placebo, which is low, and you have got a delta, your difference between the active treatment and placebo of over 30%. It looks as though it is highly effective. They are going to have to be confirmed on a phase III trial. But I think this is extremely promising indeed.
Thank you.
Okay. Both of you answering to the question. I guess the first question was about the price, and I want to follow up on this. I think we will stick with clinical outcomes today, and I think we have a little bit more work to do on the market research side. Next question.
Next question comes from Raghuram Selvaraju from H.C. Wainwright. Please go ahead.
Thanks very much for taking our questions. One for management and one for the experts. For management, I was wondering if you have done any extensive kind of market research into patient receptivity to this formulation and this route of administration, and how patients are likely to weight maybe the perceived reduced convenience against the potentially greater safety of a non-systemically administered therapy, particularly one that has an efficacy profile like this one has demonstrated so far.
From an expert standpoint, I think it would be helpful for us to understand, particularly given all of the recent developments in ulcerative colitis treatment and emergent therapies that are likely to come to market over the coming years, how you would see deployment of a therapy like this. Would it be primarily in combination with other drugs? Would it be sequenced after other drugs have been deployed? How are you thinking about that? Are there any mechanistic approaches that are currently available in ulcerative colitis that you would consider to be particularly likely to be synergistic with this one? Thank you.
Luigi, shall I just answer the first part of that question from a clinical perspective? Because market research only means so much. I can tell you in 40 years of clinical practice, patients are extremely used to using topical therapies. They do not like it, but when they work, they put up with it. The main problem of topical therapies is, as Luigi indicated, that the most effective 5-ASA preparations are acidic.
The less effective steroid preparations are neutral, and this is a neutral agent, and they would accept topical therapy, especially with these characteristics, just as you have seen in the questionnaires that the patients asked, with 82% being prepared to use it again. I will hand over to David to answer on the question of where it fits with the other agents, because you can hear a separate view, but it has got a place. David, over to you.
Sure. Well, as it stands now in ulcerative colitis, whether it is distal ulcerative colitis, as has been studied here, or more extensive ulcerative colitis, as you already heard, and I want to emphasize, some of the main disruptive symptoms are from the inflamed rectum. That is what gives people urgency and makes them socially immobile. It is what wakes them up from sleep, and it is extremely uncomfortable. So even when we use systemically active therapy for the more systemically extensive or involving colitis, we often still use rectal therapy as a bridge to control those symptoms until the new therapy may kick in.
In answer to your specific question, which is thoughtful and I appreciate it, there is absolutely no reason I can imagine why rifamycin gel would not be completely compatible with combo therapy with any of our other drugs that we are using to manage the rest of the colitis, and that it would be used as a bridge towards systemic control or other management strategies. This is a no-brainer for me, and I would be very comfortable doing that and would plan to do so right away.
Thank you. Thank you very much, sir, for the questions. I will move to the next one.
The next question comes from Ben Jackson from Jefferies. Please go ahead.
Thanks. A question or two from my side, please. The first for the professors. Could you just perhaps touch on how payers will look at this in terms of combination approaches or bridging approaches, any kind or any potential pushback that they could get for a reimbursement standpoint throughout the globe? Secondly, one for the company, so Gio, more to you. I know this is more about the clinical results here, but I still think it's important. How are you thinking about developing this program from today, i.e., when would be the optimal time to consider partnership here? Could you do it alone into phase III? Perhaps what would you hope that those phase IIIs look like in terms of either a monotherapy approach or perhaps a combination approach, too? What would you hope for there? Thank you.
I'll start with the U.S. market, and then I'll let Simon speak to Europe, perhaps, and other parts of the world. I'm the first author of the guidelines from the American College of Gastro, which were cited in the slides. In those guidelines, we recommend topical rectal therapy as part of the management strategy in combination with other therapies when there's more extensive disease or in combination with other therapies when we're bridging to them, also as a monotherapy for patients with limited proctitis. The guidelines only carry you so far, as I'm sure all these investment advisors understand. From the standpoint of payers, when we make the case of efficacy tolerability, and that it's built into guidelines with hopefully phase III data that will support it, I would anticipate that this would be viewed as a preferred strategy.
The best correlate to that I can point to would be, for example, the budesonide foam formulation available in the U.S., where we have been able to get it and use it without much trouble. This will, of course, be dependent on other market factors and pricing. But from a management point of view, disease management, not business management. From a disease management point of view, this will be an obvious one that will fit right into algorithms and our approach. So I hope and understand and expect payers would support that.
Thank you, David. From U.K., European perspective, like David, I was the author of European and British guidelines, but can't speak for the payers. It comes back to the first question, how much is it going to cost? On the other hand, the fact that it is a topical agent, it's not an immunosuppressant, it's dealing with a neglected population who is very substantially underserved by current therapies.
Then with results such as you've seen, they're confirmed, then I can't see that there would be any question that it would meet the NICE criteria, because you've got a very wide window there when you look at the cost of advanced therapies. That's why patients will like it, because it offers not only a bridge and time for an advanced therapy to work, but it may well avoid the need to escalate. I believe that the regulatory authorities and the payers will accept that as a need. So I'm very positive about its prospects, yeah.
Good. Thank you to both, and Ben, thanks for your question. On the management side, I can tell you that you know very well our business model is to fund and develop our programs ourselves. I guess, based on our earnings that we had back in July, our balance sheet is super solid to support the next step of this clinical development, meaning phase III trial. We are a business to business company. If I have to think about this asset, I can tell that there will be a lot of interest from Big Pharma, GI, after these positive results. With that said, we are focused on our own execution. The phase III planning is ongoing. We are working on the final study design, but this will be formed after we meet with the FDA, and also the European authorities.
But what we want to do is a global dossier, global registration program, potentially across North America, Europe, and a few other geographies. It is early to define all of these specifics, but the study will be powered to confirm the efficacy and the specific findings we had in this phase II trial. So we are going to clearly keep all of you up to date as we move forward into phase III, but it is exciting to be in this situation. It is exciting to have such results. I am very confident also based on the results that we had to move this fast-forward into the phase III program.
Thank you.
Good. Thank you, Ben. Next up, and I guess the last question as I see on screen.
The next question comes from Nicolas Pauillac from Kepler Cheuvreux. Please go ahead.
Yes. Hi, guys. Hope you can hear my question. Maybe two questions on my end. The first one is, I was just looking at the placebo response rate study that you had in the studies. It does seem kind of low if we compare, for instance, to what budesonide foam had in their trial. I was wondering if there was any, let's say, logical explanation to that, perhaps in the way you did the patient screening or something.
Then the follow-up question on that is, when we move to phase III, should we assume that we will get probably a, let's say, normalization of placebo rates closer to what we saw in comparative phase III trial? Or you think that you might be able to get to the same placebo rate, let's say, there? Then just one question on phase III trial. I know it's early stage to discuss all of that, but do you think that you will need to do, let's say, superiority study, or you can go ahead with just a, let's say, simple phase III?
Should I just chip in about the placebo rate? Because you're absolutely right to point out that it is low. I can tell you, and you can understand, that that came as something of a relief. Because, in mild to moderately active disease, then you often get a higher placebo rate. However, it was part of the design and an integral part of the design that patients had to have microscopically active disease confirmed before entry to the trial. The reason the placebo rate in many trials in this area in the past has been high is that people have simply taken recruited patients on the basis of symptoms alone in the past, or symptoms and endoscopy without confirming activity.
In fact, it has to be a tribute to Cosmo that when they did the budesonide MMX development, of which I was the chief investigator a number of years ago, they pre-specified that the patient had to have active disease. That's fair enough, because if you're treating ulcerative colitis, if they don't have active inflammation under the microscope, then they haven't got active ulcerative colitis. So the starting point was correct. The further aspects to your question, I'll hand over to Luigi, unless, David, you've got any other comments you'd like to make.
Thank you, Simon. I completely agree with you, and also, I thank you personally, because you have been instrumental to this study. I've been discussing the design with you a few years ago. We have been brainstorming about how to have a clean population with a low placebo rate, and this is how the study ended up. We were successful in designing this study very scientifically, and the placebo rate is low. Regarding the second part of the question, can you please repeat the question, if you don't mind?
Yeah. Sure. Thanks for the call. It was just to have, let's say, your first thoughts on how we should think about the phase III design. Like, how you're going to be, let's say, forced to do non-inferiority studies to standard of care or things like that.
Well, let's say it's premature to provide any information about a phase III program that will come after negotiation with both FDA and EMA. For sure, what we can see from historical recent approvals of other drug products in the field is that the standard of care or the standard design is a placebo-controlled trial, so this is likely to be our design. But it's really premature to make any forecast on how the design will look like because, again, this will really depend on the view of the regulators, how they see this therapy, and as well as the, let's say, decision about this.
Okay, super. Thanks. Yeah. Thanks a lot.
Thank you.
Great. Let me ask if there is any additional question.
So far, there are no further questions from the phone.
Good. Let me close by thanking first Professor Rubin and Professor Travis. Thank you so much for your participation. I think you were able to address all the questions that we have received. Thank you, Luigi, for the presentation. I want to leave you all with three main points. First, this study still remains a real clinical need. We heard this over and over the last 40 minutes. Secondly, TAG showed strong remission signals with a new mechanism of action and a new way of treating those patients.
And third, Cosmo knows the disease from years. We have done this before, and we now want to move this into phase III and successfully bring to market another therapy that can be benefited from millions of patients globally. Our focus now is phase III execution, and we will keep you updated with the progress. Thank you, everyone, for the participation and the engagement. Bye.
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