Welcome to the Epitope Top-Line Results Call. My name is Adrian, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press zero one on your touch-tone phone. As a reminder, conference call is being recorded. I'll now turn the call over Anne Pollak. Anne, you may begin.
Thank you. Good afternoon, everyone. This afternoon, DBV Technologies issued a press release announcing the top-line results from Epitope, our phase III trial of Viaskin Peanut in peanut allergic toddlers. The press release is available in the Press Release section of the DBV Technologies website. Before we begin, please note that today's call may include a number of forward-looking statements, including, but not limited to, comments regarding our clinical and regulatory development plans, the timing and anticipated results of interactions with regulatory agencies, our forecast of our cash runway, and the ability of any of our product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements are not promises or guarantees and are based on the assumptions that are subject to risks and uncertainties that could cause the company's actual results to differ significantly from those suggested by these statements.
Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Please refer to the company's filings with the SEC and the French AMF for information concerning the risk factors that could cause the company's actual results to differ materially from expectations, including any forward-looking statements made on this call. Except as required by law, the company disclaims any obligations to publicly update or revise any forward-looking statements to account for or reflect event circumstances that occur after this call. Joining me on the call today are Daniel Tassé, Chief Executive Officer of DBV, and Pharis Mohideen, Chief Medical Officer. I will now pass the call over to Daniel. Daniel.
Thank you, Anne, and thank you all for joining us by phone or by webcast. What a very important Viaskin Peanut update. Today, we will focus on the positive top-line results from Epitope, the phase III trial of Viaskin Peanut in children ages 1 to 3. Now, today, when we speak about toddlers, we are referring to children between the ages of one and three years of age. First and foremost, it is a very important population with high unmet needs, and I will come back and discuss that a bit further in a few minutes. For now, let's start with the clinical results. I'm very happy to report that the study met its primary endpoint. Viaskin Peanut demonstrated a statistically significant treatment effect.
67% of subjects in the Viaskin Peanut 250 microgram arm were treatment responders at 12 months, and that compared to 33.5% of subjects in the placebo arm. Very importantly, the lower bound of the 95% confidence interval of the difference between treatment arms was 22.4%, far exceeding the pre-specified threshold of 15%. We were also very pleased to see that the safety profile results of Epitope are generally consistent with the known safety profile of Viaskin Peanut observed in children with peanut allergy ages four and older, from prior clinical trials. Now, in a few moments, Pharis will review the data in detail. Before he does that, I'd like to provide some context on the toddler segment of the peanut allergy patient population.
As we all know, the years between ages one and three are characterized by amazing growth and milestones. Children enter toddlerhood as babies and emerge walking and running and usually chattering away. During these years, children afflicted with peanut allergies are most likely to be diagnosed as they expand their range of foods and as they try new things. Now, DBV has long recognized the need to have treatment options available for children when they are diagnosed. The clinical goal of peanut allergy treatment is to reduce a child's risk associated with an accidental peanut ingestion.
There is also a more nuanced treatment goal and one that's also very important, and that is to alleviate the fear, the stress and sense of isolation a child with peanut allergy and their caregivers may feel from constantly avoiding peanuts and having to educate friends and classmates to be mindful of the risk that peanuts pose to them. At the time Epitope was designed, there were no FDA-approved treatments for peanut allergic toddlers. Unfortunately, that is still the case today. Now, all of us at DBV are proud, very proud, that the Epitope results contribute to the growing body of research focused on food allergy immunotherapy in toddlers. With that as background, let's focus on the data. I will now turn the call over to Pharis to review the results in detail.
Thanks, Daniel, and thanks to everyone on the call with us today. Let's jump right into the data. As Daniel mentioned, Epitope evaluated the safety and efficacy of Viaskin Peanut in peanut-allergic children ages one to three. As you can see from the slide, Epitope enrolled 362 subjects in part B at approximately 50 centers across the U.S., Canada, Europe, and Australia. A double-blind, placebo-controlled food challenge was administered at baseline and month 12 to determine the subject's eliciting dose or ED. Treatment responders at month 12 were defined as either a subject with a baseline ED less than or equal to 10 milligrams, who then reached an ED greater than or equal to 300 milligrams of peanut protein, or a subject with a baseline ED greater than 10 milligrams who reached an ED greater than or equal to 1,000 milligrams of peanut protein.
These are exactly the same response criteria used in our previous pivotal study, PEPITES. Here we see the age distribution and baseline eliciting dose. There were 244 subjects in the Viaskin Peanut arm and 118 in the placebo arm. Overall enrollment was balanced for age between the active and placebo treatment arms with an even distribution of about one-third of subjects in each age group. The median baseline ED was 100 milligrams in both the active and placebo arms. Here is the primary efficacy endpoint at month 12. 67% of subjects in the Viaskin Peanut arm met the treatment responder criteria, compared to 33.5% of subjects in the placebo arm. Viaskin Peanut demonstrated a statistically significant treatment effect with a P value less than 0.001.
The difference in response rates was 33.4%. The lower bound of the 95% confidence interval was 22.4%, which exceeded the pre-specified threshold of 15%, and thus, the primary endpoint was met. We expected a higher placebo response rate in this age group relative to the older PEPITES population, given the natural resolution of peanut allergy that may take place in this 1- to 3-year-old age range. In an additional pre-specified efficacy analysis, treatment response was defined as subjects reaching an eliciting dose greater than or equal to 1,000 milligrams of peanut protein at month 12, regardless of baseline ED. In this analysis, 64.2% of subjects in the Viaskin Peanut arm met this treatment response criterion, compared to 29.6% of subjects in the placebo arm.
The difference in response rate was 34.7%, and the P value was less than 0.001. Okay, moving on to safety. The Epitope safety results were generally consistent with the safety profile of Viaskin Peanut 250 micrograms observed in children with peanut allergy ages four years and older in prior clinical trials. No imbalance in the overall safety adverse event rate was observed between the active and placebo arms. Overall, 8.6% of subjects in the Viaskin Peanut arm and 2.5% in the placebo arm experienced a serious adverse event. Only one SAE, a mild periorbital edema, was deemed related to treatment, to active treatment. 3.3% of subjects in the Viaskin Peanut arm discontinued due to an adverse event.
1.6% or a total of four subjects in the Viaskin Peanut arm experienced an anaphylactic reaction determined to be related to treatment or possibly related to treatment. Among these anaphylactic reactions, three resolved with a single dose of epinephrine, and one resolved without epinephrine. All anaphylactic reactions were mild to moderate in severity and were characterized mainly by skin and respiratory symptoms. The most commonly reported adverse events were skin reactions localized to the administration site that were mostly mild to moderate in nature. 22.5% of the subjects in the Viaskin Peanut arm experienced an application site reaction that was assessed as severe by an investigator, compared to 8.5% of subjects in the placebo arm.
Based on examination of the skin using the study protocol-defined skin grading system, the severity of administration site skin reactions decreased throughout the course of the 12-month study. In summary, Viaskin Peanut resulted in a robust treatment effect in 1- to- 3-year-olds with peanut allergy. There was a 67% response rate with Viaskin Peanut compared to 33.5% for placebo, with a lower bound margin of the 95% confidence interval being 22.4 and the P value being less than 0.001. The 33.5% placebo response rate is consistent with an approximately 22% natural resolution rate for this age range, as cited in the literature, plus the expected placebo response associated with the double-blind, placebo-controlled food challenges as conducted in this study.
Safety is consistent with what was observed in our previously conducted studies, with a low rate of discontinuations due to adverse events. Local application site reactions were the most commonly reported adverse events. The related or possibly related anaphylactic event rate was 1.6%, with none of the events being severe. Now, before I turn the call back to Daniel, I want to sincerely thank the study subjects and their parents, caregivers, and allergists who participated in Epitope. We are so grateful for your contribution. Now I'll turn it back to Daniel for some closing remarks.
Thank you, Pharis. The question becomes, now what? How do the Epitope results affect the pathway for Viaskin Peanut? Now, based on these data, and given the high unmet need and absence of approved treatment in this important population, we will explore regulatory avenues for Viaskin Peanut in children ages 1 to 3. Separately, we continue to have productive dialogue with the FDA on the protocol for VITES, the phase III trial of the modified Viaskin Peanut patch in allergic children ages 4 years and older. As I mentioned earlier, the Epitope results are an important and positive milestone for Viaskin Peanut. The data support the clinical benefit of Viaskin Peanut in toddlers and further advance our understanding of the ability of epicutaneous immunotherapy to induce an immune response with minimal amounts of allergen by targeting a completely different immune pathway than used in oral immunotherapy.
The Epitope results also validate the unwavering support of everyone who has contributed to the development of Viaskin Peanut. First and foremost are the toddlers who participate in Epitope, their families, their caregivers, and their loved ones. To all of them, the biggest of thank yous. I also want to acknowledge other stakeholders who have remained committed to the promise of Viaskin Peanut and work diligently to advance its development. Food allergy families and patient advocacy groups, all allergy healthcare providers, all DBV employees, and our investors. I know you are as excited by the Epitope results and the future of Viaskin Peanut as I am. I want to thank everyone on the phone and webcast for joining us today. Operator, let's please open the line for questions.
Thank you. We'll now begin the question and answer session. If you have a question, please press zero one on your touchtone phone. If you wish to be removed from the queue, please press zero two. If you're using a speakerphone, you may need to pick up the handset first before pressing the numbers. Once again, if you have a question, please press zero one on your touchtone phone. Our first question is from Jonathan Wolleben. Your line is open.
Hey, good afternoon, and congrats on the data.
Thanks, John.
A couple from me. Wondering, can you remind us of the adhesion rate you guys saw in PEPITES? Also how the adhesion rate looks here with the original patch in the younger children?
Yeah, we have not. Let Pharis add some comments here. We just unblinded this recently. We have not looked in depth at the adhesion pattern. What's important to recognize, Jonathan, is that, you know, the FDA asked us to redesign the patch in children four and older, and we've done that. That's the data set we will complete with the VITES results. This is a completely different data set in a completely different population, and we will look at querying the data and figuring out the dialogue we wish to engage with the agency, if we choose to do so, after diving in the data a bit deeper.
Okay.
Pharis, anything you wish to add?
No, go ahead. Go ahead, John.
When you guys talk about anaphylaxis related to treatment, just wondering if you could provide a little more color. Is that, you know, anaphylaxis during a food challenge, or is it due to an accidental exposure? Just wondering if you could provide a little more clarity on what's actually going on with these, you know, limited number of anaphylaxis.
Yeah. These are treatment-related anaphylactic events, so these are not the accidental peanut consumption. These are not the food challenge-related anaphylactic events.
You didn't see any, you know, anaphylaxis, related to accidental exposures?
We did, as you would expect. The data set here, because remember, these are all multi-allergic type patients, right? They have milk and egg and other things. For this data set that we presented, we felt it was most important to show what was related to the product and what investigators and the parents, caregivers deemed to be related to the product.
Got it. Just, I guess, two more short ones. The 1,000 milligram eliciting dose data is quite compelling. Wondering, is that the highest you went in the food challenge? Then also, what are you measuring in the open label enrollment? Is there gonna be another long-term food challenge or a look at, you know, sustained unresponsiveness? Can you give us a little more color about what you're collecting in the extension? I'll hop back in the queue.
Yes. Go ahead.
No, no, you take it first.
Oh, okay. Yeah. We do have a crossover open-label extension called EPOPEX, and they do have the ability to have food challenge data in that. It's not controlled though, remember, because it's the placebo group that crosses over, just as we did with the PEPITES and PEOPLE. At the end, there is a higher dose than the 1,000. There's a 2,000 milligram dose also. Is that clear, John?
Yes. Thanks for the comments.
Yep. Great. No problem.
As a reminder, if you have a question, please press zero one on your touchtone phone. Again, it's zero one to ask a question, and we're standing by for more questions. We currently have no questions in the queue. Oh, Jonathan, just re-queued up. Your line is back open, Jonathan.
Just wondering if you could provide a little more, you know, thoughts on next steps here in the 1-3-year-olds. Do you think this is the original patch moving forward, or is there gonna be some sort of bridging with the modified patch? Just, you know, how are you thinking about today, given, you know, how good this initial data read looks?
We're just shaping our thinking here, John, on this. As I mentioned, we unblinded this literally very, very recently. Again, we look at this as being a product with very, very strikingly positive data in a patient population, 1- to 3-year-olds, where there's no other product that's approved. That to us is a distinct regulatory set of arguments that we have in mind with the agency than the work it asked us to do in the children 4 and older. That's essentially our frame of reference at this point in time. Again, we need to give this a lot more thought as to what is the right way to approach agencies if we choose to do so.
at this point in time, we see this as pretty important data around a product that showed, we believe significant benefits in a population that have high unmet needs. That should be the core thesis by which we articulate whatever we choose to do next. Does that make sense?
Thanks again.
Yep.
Just as a reminder, if you wanna enter the queue, please press zero one on your touchtone phone. Currently, we have nobody in the queue. We have no further questions.
Operator, well, we thank you, and thank you, everybody, for joining the call today. Wish you a great evening.
Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.