Welcome to the DBV Technologies Clinical Update Conference Call. My name is Vanessa, and I will be your operator for today's call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session. To queue up with your question, you can press zero then one, and these instructions will be repeated for you. I will now turn the call over to your host, Anne Pollak.
Thank you Vanessa. This afternoon, DBV Technologies issued a press release announcing the initiation of the VITESSE, a phase III trial for the modified Viaskin Peanut patch. 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, enrollment projections, and other anticipated study milestones, the timing and anticipated results of interactions with regulatory agencies, our forecast of our cash runway, and the ability 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 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 and estimates. Please refer to the company's filings with the SEC and the French AMF for information concerning 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 obligation to publicly update or revise any forward-looking statements to account for or reflect events or 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.
Anne thank you. Good evening to all joining us today on the teleconference and on the WebEx. Let me start with, as we say in French, excuse my humblest apologies. We're running a bit late simply because the phone signal and Wi-Fi signal at the hotel where I am isn't there. Our apologies for that. Hopefully, you can hear me well. Now, back to the matter at hand. As Anne mentioned, today we announce proudly initiation of VITESSE. VITESSE is a phase III double-blind, placebo-controlled, randomized study to assess the efficacy and safety of the modified Viaskin Peanut patch in children four-seven years old with peanut allergy, and it will be a 12-month treatment. We have planned for an enrollment of 600 subjects randomized 2:1 across approximately 80 sites in North America, in Europe, the UK, and Australia.
We expect the first patient to be screened in the fourth quarter of this year and the last patient screened by year-end 2023. We thus anticipate top line results for VITESSE will read out in the first quarter of 2025. VITESSE will evaluate the modified Viaskin Peanut patch. Now, the modified patch, and many of you know our technology well, as you know contains the deposits of dry peanut protein on a backing film that sits above the skin on an adhesive foam crown that we often refer to as the foam ring. When the patch is applied to intact skin, a condensation chamber is formed within the foam ring between the allergen backing and the top layer of the skin, the epidermis.
Also, there's a top layer to the Viaskin Peanut patch, which is a breathable over-adhesive dressing that is meant to help secure tightly the condensation chamber to the intact skin. If you are joining us by WebEx this evening, you can see two patches on the slide. The patch at the top, the circular patch. The larger patch is the modified patch, the modified Viaskin Peanut that we will be evaluating in VITESSE. We've communicated quite a bit already on the development of the modified patch. The rectangular patch, which we previously referred to as Current Viaskin Peanut or CVP, is the patch that was evaluated in EPITOPE, our study in 1-3 year-olds, as well as in 5-11 year-old children with peanut allergy in PEPITES and in REALISE.
Again to repeat, there is absolutely no difference in the condensation chamber of the two patches, the modified patch or the original CVP. When developing the modified patch, what we changed are the shape and size of the over-adhesive dressing to improve adhesion. As we've shared with you, we have data showing that it performed better on that dimension. We also eliminated the peel tab, added a notch to the paper applicator, which may feel like a small thing, but it's meant to support easy- proper application of the patch to the patient's skin. These little design changes actually have a significant impact.
We created the modified patch in response to the Complete Response Letter DBV received in August of 2020 in connection with the Biologics License Application for the rectangular Viaskin Peanut patch in children ages 4-11 years. In the CRL, the FDA identified concerns regarding the impact of patch site adhesion on efficacy and indicated the need for patch modifications. To address these concerns, we developed a modified over-adhesive dressing that is larger and circular in shape, and we notified the FDA that we intended to conduct a phase III efficacy and safety trial with the modified patch. Now, over the last several months, DBV and FDA have engaged in ongoing discussions about the EPIT platform, about the very nature of our technology as a novel drug device combination that is intended for delivering allergen immunotherapy.
The fact that it's a novel device that has no analog was a big part of our discussions here. We also discussed with them elements of design of the VITESSE trial. We then submitted initial protocol to the FDA as part of the briefing material to the Type C meeting that was granted to DBV in the second quarter. Following submitting the Type C meeting material and initial protocol, we've had subsequent exchanges between DBV and FDA that ensued on critical design elements and endpoints which were included in the final protocol. These recent interactions with the FDA advanced alignment that VITESSE would evaluate the efficacy and safety of the modified Viaskin Peanut patch as peanut immunotherapy, and data from VITESSE may potentially support a future BLA submission.
I'm thrilled to report the process of sending the final protocol to study sites for subsequent institutional review board approval has begun. It is with these first protocol submissions to sites that we consider VITESSE initiated. As you know, IRB review can take anywhere from a few weeks to a few months, and we expect sites will begin screening subjects in the fourth quarter, and we will keep you updated on a regular basis on enrollment as it progresses. Now, importantly to the trial design, let me turn the call over to Pharis, our Chief Medical Officer, to provide you more details on the VITESSE protocol.
Thanks Daniel. Many of you on the call know the existing Viaskin Peanut data set very well. I'm sure you will recognize the close similarity of the test to PEPITES, our phase III efficacy and safety trial that used the rectangular-shaped Viaskin Peanut patch in children ages 4- 11. We have used all our learnings from the Viaskin Peanut program to align the VITESSE protocol with patients most likely to benefit from Viaskin Peanut treatment with the modified patch. The first change you likely noticed is the age of the target population, 4- 7 years old. We decided to target this age group after careful review of post hoc analyses of PEPITES's efficacy data and in consideration of the recently announced EPITOPE data.
The VITESSE age inclusion criterion is aligned with an age cohort of peanut allergy patients who have demonstrated a higher response rate in previous peanut allergy treatment studies. We intend to present the results of a post hoc efficacy analysis of PEPITES's participants based on age at study entry at the upcoming annual scientific session of the Canadian Society of Allergy and Clinical Immunology later this month. The second significant change is the inclusion criteria regarding the eliciting dose, or ED, of the subjects. An eliciting dose is the amount of peanut protein that induces unmistakable allergic symptoms such as hives, wheezing, vomiting, or dizziness. Subjects with eliciting doses of 1, 3, 10, 30, and 100 milligrams will be eligible to enroll in VITESSE.
Defining the VITESSE eligibility ED criteria of less than or equal to 100 milligrams of peanut protein identifies those subjects who are at the most risk of reactions to accidental peanut exposure and with the highest unmet need. The 100 milligram ED is lower relative to the 300 milligram ED used in PEPITES. Eligible subjects will be randomized 2: 1 to receive Viaskin Peanut or placebo for a treatment period of one year. The primary efficacy endpoint is the percentage of treatment responders in the active versus placebo arms at month 12. The primary efficacy analysis includes the success criterion of a lower bound of the 95% confidence interval being greater than or equal to 15%. As in PEPITES, subjects in VITESSE will be stratified into two groups based on their eliciting dose at baseline.
Subjects with an ED less than or equal to 30 milligrams of peanut protein will be a treatment responder if their ED increases to 300 milligrams or more at month 12, as determined by an exit double-blind, placebo-controlled food challenge. Subjects with an eliciting dose of 100 milligrams of peanut protein at baseline must have a month 12 eliciting dose of at least 600 milligrams to be a treatment responder. The month 12 food challenge will be conducted with an additional dose step of 600 milligrams before the final dose of 1,000 milligrams. We added the 600 milligram food challenge dose to increase both the safety and sensitivity of the exit food challenge assessment. The efficacy assessment of the test provides a smoother ascent in the escalating food challenge doses that should feel more comfortable to families and yield more comprehensive efficacy data.
The addition of the 600 milligram dose in the food challenge was agreed with the FDA. Overall, the test will target a younger age range and lower ED patient population relative to PEPITES. These patients may be considered the most vulnerable and at the highest risk for severe allergic reactions and can potentially benefit the most from Viaskin Peanut. The treatment responder criteria have been accepted by the FDA, and they represent clinically meaningful improvements in ED. There was extensive statistical modeling of available data behind these changes, and we are confident that Viaskin Peanut will perform as expected. However, estimating the placebo response can sometimes entail more uncertainty and be less predictable. To be conservative, we increased the number of subjects in the test relative to PEPITES to 600 subjects from 356.
Given that ease and simplicity of use has always been a key characteristic of our device, and the modifications made to the product and instructions for use are anticipated to build upon this, we believe the recruitment of the test can be accomplished at a rate similar to PEPITE. Positive feedback on the recently announced EPITOPE results from patient advocacy groups and our study sites indicates that there remains a very high interest in Viaskin Peanut and continued enthusiasm to support the VITESSE study. The assessment of safety parameters in the test will be essentially the same as in PEPITE. We will evaluate the safety of the modified Viaskin Peanut patch based on overall adverse events, local site reactions, and systemic allergic reactions. The last aspect of the VITESSE protocol I'd like to discuss is patch adhesion assessment in the trial.
As Daniel referenced earlier, the recent exchanges between the FDA and DBV focused on the EPIT platform as a novel drug device combination for delivering allergen immunotherapy. Like other forms of allergen immunotherapy, regular exposure to the allergen is what matters in driving the desensitization process. For our product, this means applying one patch each day to provide the immune system daily exposure to peanut protein via the epicutaneous route of administration. The instructions for use or IFU have been modified to be better aligned with an allergen immunotherapy product, and specifically ,one that is intended to be used for multiple years. The IFU will direct caregivers to apply one patch at approximately the same time each day following removal of the previous day's patch.
In VITESSE, the modified patch is to be worn for as close to a full day as possible, with a minimum daily wear time of at least 12 hours each day. The PAPITE data supports these instructions and the concept that on average, more hours of wear time each day tends to result in a better treatment effect driven by the antigen transfer and uptake process. As you know, Viaskin Peanut was developed to provide high compliance in real-world settings, such that over the course of a 12-month treatment period or even longer, small variability in day-to-day application time should not play a critical role in treatment success. In VITESSE, we will collect adhesion data focusing on average daily wear time as the key parameter in patch performance. In conclusion, VITESSE incorporates key learnings from previous clinical trials of Viaskin Peanut, including PAPITE and other peanut allergy treatment studies.
We are confident we have designed a trial that will support the clinical and regulatory development of the modified Viaskin Peanut patch. I'll now turn it back to Daniel. Daniel?
Thank you Ph aris. As we've mentioned before, VITESSE means speed in French, and we decided to conduct a new phase III pivotal trial with the modified patch because we believe it is the fastest way to potentially bring Viaskin Peanut to families and allergists. We also feel confident that data from VITESSE will further strengthen the potential Viaskin Peanut label and enhance its commercial potential. I wanna talk a bit more about that. We defined the inclusion criteria of VITESSE to address the higher unmet need of younger, more sensitive peanut allergy patients. Now, we know because we're in the market all the time, we talk to allergists, we talk to patient advocacy groups, we talk to parents.
We know from that market research and those discussions as well as from review of food allergy quality of life studies, that caregivers of children with peanut allergy have two goals when considering peanut allergy management and treatment. The first goal is to protect their child from a reaction to an accidental allergen ingestion. That's the great fear that parents have, unfortunately, that today is the day my child will consume the allergen, and with that comes the serious consequences that may follow. The second objective is to prevent that food allergy from negatively impacting their child's quality of life, and that's not a one day thing, it's an everyday thing. Now, caregivers of children of peanut allergy consistently cite those two goals regardless of their child's age.
However, we also know that caregivers cite stressors that are specific to younger age groups such as: One, younger children don't have the ability to self-manage their food allergy. Also, second factor, is that young children are transitioning at that age to more independent environments such as daycare, such as school and extracurricular activities, and la stly, in young children, parents want to avoid this perception that food allergy will increasingly impact their child's quality of life. Now, we also know, so that goes to the psychology of treating the younger children and the unmet need that's embedded in that. We also know that children with peanut allergy who are highly sensitive to peanut protein are at a greater risk of having allergic reaction to accidental exposure to peanut.
Here, I'll pay attention to the right-hand side of the slide that shows the relationship between eliciting dose and exposure dose. Exposure dose being the amount of allergen that is accidentally ingested. An allergic reaction is predicted to occur when a patient's eliciting dose is less than the accidental exposure dose. Now, this has been well researched. The median amount of peanut protein associated with real-life accidental exposure reactions is approximately 125 milligrams. Based on the modeling theory depicted on this slide, children with eliciting dose of 100 milligrams or less, those are the children that will be included in VITESSE, will have a reaction to that median typical accidental exposure dose of 125 milligrams. It's the leaping from one side to the other of that risk chasm that we are looking to achieve with VITESSE.
Now, there are approximately 530,000 children aged 4-7 with peanut allergy in the United States. Five hundred and thirty thousand children, 4-7 , suffer from food allergy or live with food allergy in the United States. We believe caregivers and allergists of younger and more sensitive patients are especially motivated to seek a peanut allergy treatment that will reduce the risk of experiencing allergic reaction to peanut protein. We also believe, the product profile of Viaskin Peanut will be attractive to patients, caregivers, the patient's loved ones, and the allergy treating community. In closing, we have shared a lot of information with you today. VITESSE, as Pharis explained, builds on very thorough analyses we have made of the very rich PEPITES data. Now let me summarize it for you as you can see on the slide.
VITESSE versus PEPITES will use a larger circular patch, the modified Viaskin Peanut. We are targeting younger patients, ages four to seven, who we know are better responders from PEPITES and are also closer to the age of diagnosis. We are targeting patients with lower baseline ED, as they represent the higher unmet need. We also modified the responder criteria in agreement with FDA. As Pharis said, there is no patch detachment endpoint. We will focus on IFU that is targeted to daily wear time, as that is what optimizes the allergen delivery. The statistical success criteria is the same as in PEPITES, and we are running a larger trial to be conservative in our assumptions, and we are confident we can enroll VITESSE at a good pace. Initiation of VITESSE is an essential next step to bringing Viaskin Peanut to allergists and to allergy families.
I want to take a second to thank everyone at DBV who's been working tirelessly to advance this innovative therapy, as well as all investigators and their staff in the AD sites that will help us in this important mission. Operator, let's open the call to questions.
Thank you. We will now begin our question and answer session. If you have a question, please press zero, then one on your touchtone phone. If you wish to be removed from the queue, please press zero then two. If you're using a speakerphone, please pick up the handset first before pressing the numbers. Once again, if you have a question, please press zero then one on your touchtone phone. We have our first question from John Walden. Please go ahead. Your line is open.
On the progress, and thanks for taking the questions. You mentioned this earlier, but I was hoping you could give any more color on the differential response rates for the 4-7 and the 7-11-year-olds you saw in the PEPITES for both the children who are on Viaskin Peanut and then also those who are on placebo?
Yeah. We're about to have this data published and showed at the Canadian Allergy Society meetings in Quebec City in two weeks. We don't want to front run that since we've been working closely, as you know, with the allergy community. We do know that what we saw in EPITOPE, younger children respond better to epicutaneous immunotherapy to Viaskin Peanut. We've seen the same pattern, the same trend in the younger children versus the older children with PEPITES. That's what we use in our modeling among the many variables we looked at to land on this population here. I'll leave it up to the investigators who show the data in a few weeks to help you quantify that, but the difference is significant.
Is there any reason to expect a better response with the new modified patch? You mentioned the allergy chamber is the same. Should it behave the same, or should there be any difference, you know, good, bad, between the two patches?
Yeah. Let me give you my thoughts on this. Pharis may have, I'll invite him to make some comments also. His view might be different or more nuanced. Look, we've shown, and we published the SOLAIRE data and the PEPITES data, that it takes about 12 hours for the antigen to be delivered and w e've seen in PEPITES that patients who achieve 12 hours or more, which is roughly 90, a bit more than 90% of patients achieve an average of 12 hours of wear over one year, tend to be better responders than the patients who did not hit 12 hours. As you extend from 12 hours up to 24, the clinical response rate kept on improving slightly, but not on the same slope. There's an improvement with time here. We know that's the phenomenon.
To your question, could the modified patch bring a better clinical response? It's possible. It will help. We like to think more patients get to 12 hours, but again, we need data to verify that, John. That's just a hypothesis. Whether or not that also translates into better clinical response in patients who pass the 12 hours is an interesting question that we should be answering with data. Pharis, you may have some thoughts to add here.
I agree with you Daniel. I think that's the thesis of this study, at least one of them to be answered. Jonathan, yeah, I think there's a potential that it may improve some of the patients who perhaps had poorer adhesion than the rest of the cohort. Again, if you go back to that decile data, it's just one of the deciles. Maybe those are the patients who may target an improved or modified product. But for most of the patients, as Daniel said, they averaged about 20 hours a day. We don't expect to move that number too much here.
Got it. I noticed you discussed this a bit. For the patients with a higher eliciting dose at baseline, the threshold now 600, down from 1,000. Is that a function of the riskier patient population you discussed? I'm wondering what data you had to give the FDA to give them comfort that that lower threshold is sufficient here.
I'll have Pharis answer it, but the FDA was comfortable with a 600 milligram dose in the exit food challenge. That was part of our discussions with them not since the CRL, actually. We were confident that they would be accepting of that. I'll let Pharis add a bit more detail about the reality of performing the food challenge.
Yep, sure. In the previous study, John, as you know, we went from 300-1,000. That was a pretty big jump when you think about it. We did receive feedback that the caregivers were, you know, quite stressed about that. We do listen to what our patients and caregivers say. That was one reason. The other thing that I would say is the 100-600 is still a 6x increase, which is quite meaningful. These are absolutely clinically meaningful changes. As Daniel had presented, if on average it's 125, and you're taking someone from 100-600, that's clearly a meaningful jump. Again, we had these discussions with the agency, and they were aligned with this response criteria.
One more if I may. Wondering how this development interplays with your path forward in the 1- 3 year-olds, and you mentioned, you know, 530,000 4- 7 year-olds. You know, what's your best guess on how many peanut-allergic 1- 3 year-olds out there, and, you know, can you get there quicker than the 4- 7 year-olds?
It's always an important question that's been pretty much dominating the work we've done here. To be clear, the more we look at the 1- 3 year-old data, it remains very impressive, very solid. Now, as we shared, job one for us is to get VITESSE going because that could be rate limiting obviously to our ability to launch the product. The FDA has a lot of things going on also, so to be respectful, obviously, of their time, we want to get VITESSE done on the back of the quick discussions and the Type C meeting that took place back in Q2. Now that that's essentially done, we're going to plan on having a discussion with the FDA, on what can we do with the 1- 3-year-old data to maybe accelerate the launch of the product.
Again, that discussion with the FDA has not taken place. We expect it will take place between now and the end of the year.
Is that helpful? Thanks again and congrats.
Yeah, very much so.
Thanks again.
Yeah, thank you.
Thank you. I'm standing by for further questions. If you'd like to queue up with your question, please press zero then one on your touch tone phone. Once again, if you have a question, you can queue up by pressing zero then one. I will stand by. We have a follow-up question from John Waldon.
When you guys gave the update a few weeks back on your cash position, you mentioned that you think it's past the completion of VITESSE, which now you're saying is first quarter 2025. Just wondering if you could give a little bit more color on that runway and what that gets you.
Yeah. We obviously have a precise forecast. At this point in time, we will leave it to the fact that it's, you know, two and a half years. Two years is a long time. We have sufficient cash to take us to the top line of VITESSE with comfort on top of it. I think investors should take comfort in that. There's also other activities, you know, besides VITESSE that we want to undertake, advancing our milk program being one of them, all of which is included in that budgeting effort.
Perfect. Thanks Daniel.
Yeah.
Just to confirm sir, I have no one else in queue. Do you have any further questions?
No thank you.
Thank you sir.
John, thank you.
It seems that's all the questions we have today. We'd like to thank everyone for joining. We'd like to thank you for your participation. You may now disconnect.