to the H.C. Wainwright 26th Annual Global Investment Conference. My name is Abby Gray, and I am an associate at H.C. Wainwright, and I would like to welcome Daniel Tassé, CEO, and Pharis Mohideen, CMO of DBVT or DBV Technologies company.
Thank you. Happy to be here, Abby. Thanks for having us.
I was just going to get us started with an introduction to the company's core technology or VIASKIN and kind of the overarching mission.
Sure. We're an immunology company targeting food allergies in children, using a technology that is unique and pretty clever, and breakthrough, which is to recognize that the human skin can be a pretty powerful immune organ to desensitize against allergens. So the technology that DBV developed by name of VIASKIN, is that via the skin, we can recruit an immune response and desensitize children against food allergies. Peanuts, VIASKIN peanut, is our new product. So that's our mission.
Wonderful! Let's start, let's start there.
Thanks.
Can you give us an overview of the VIASKIN peanut program, and how your product is differentiated from what's currently on the market?
Let's take the program. I'll go on differentiate.
Yeah. So we have two ongoing programs. So we have the one to three-year-old indication in toddlers with our original patch that's square in shape. And then in parallel, we have the four to seven-year-old indication in children with the modified product, which is slightly larger, about 50% larger, and it's circular in shape. All of the other components of the patch, the foam ring, and the 250 mcg are exactly the same. So we're running both programs in parallel, and they're considered separate BLA tracks by the FDA.
When it comes to the standard of care for, to label it, has been oral immunotherapy. So giving children escalating doses of the allergen that makes them sick until they build an immune response that you can probably describe as this fatigue. The body just stops responding to it. That provides protection. The challenge with that is that when you interrupt treatment, the rebound effect can be significant. Most importantly, that daily discipline to give the allergen to your child is very cumbersome to families, requires the child to be at rest for two hours a day or more to avoid the risk of acute allergic reactions to the protein, and making for a product that, although has good clinical results on paper, is really not very practical commercially. What we're offering, in many ways, is exactly the antithesis of that.
The patch is easy to administer. It takes 15 seconds or so. To the parents, it's important because it's rather validating that we're doing something important for the child, important to the child also. There's no restrictions of daily living. You put the patch on, you climb a tree, you go play baseball, you go play tag with your siblings. So the products could not be any different when it comes to the burden on families for clinical outcomes that are quite similar. And to be clear, what we're really trying to solve for these families through the reduction of the odds that you're going to have allergic reaction if your child accidentally eats peanut or a wheat product, that causes huge anxieties in families.
The ability to rest much more assured if there is accidental consumption of peanut, the consequence will be very little, if nothing, is really the value proposition for all forms of immunotherapy. Our product provides that with very little burden, if any at all, on families.
Right.
Does that answer your question?
That does.
Yeah.
Then you did talk about a little bit the differentiation between the two age groups. Can you kind of comment on if you're going to pursue any additional age groups or kind of where, what, you know, where you guys are with that kind of age range?
Yep. Yeah, so obviously, we're focused on getting the one to three and the four to seven across the line after. But as you can imagine, we have a platform technology, so we can change the size, shape, amount of peanut protein on that. And so as we get into what you may be asking about is a lifecycle management type program, we can obviously pursue older ages if we modify the patch or dosing regimens. Those things are remaining to be seen. Obviously, we have to get approved first, but for me, as the Chief Medical Officer, I'd be like a kid in a candy store to be able to throw different, you know, formulations or size or, or dosing regimens. So I'm really looking forward to that day.
If I may add to that, the unmet need is highest in younger children, obviously, because they're not an age to advocate for themselves, ask questions to the babysitter, read labels, obviously. So besides being organically a more attractive market, it also happens to be children whose immune system is most plastic, actually, the best responders. So there's a nice sort of confluence of those two things.
That also kind of goes into... As my next question is, thinking about the market opportunity for VIASKIN peanut and the current unmet need that VIASKIN peanut will address upon approval. So you've kind of commented on that, but is there any further, you know, comment you have about that?
We can certainly quantify it. We estimate there's 280,000 children, age one to three in the U.S., diagnosed with peanut allergy, unlikely to grow. By the way, 75%-80% of kids don't outgrow a peanut allergy. So that's pretty significant. If once diagnosed, it's likely to stay with you for the rest of your life. So 280,000 , one to three, 390,000 , age four to seven, put it together, it's a really large number of patients, with, again, a product that would be chronic therapy, and one we like to think is not burdensome to the family. So, the unmet need is significant, the epidemiology is significant, commercial potential is significant.
And then can you walk us through the current snapshot of where things stand for the VIASKIN peanut program? Since VIASKIN has kind of a little bit of a varied history to kind of get to where you guys currently are, can you talk about the modifications that have been made to the original patch? You did kind of comment square versus circular, just, you know.
You want to take it first?
Yeah. So as I said, the circular patch is the modified patch that we're using in the four to seven-year-old study. It's got about 58% more surface area in contact with the skin. The other components of the patch remain unchanged completely. We have this study. We call it VITESSE. It's ongoing at this time. We're on track to close recruitment at the end of this month. So we had said before third quarter, and we're right on track for that. And then with the original patch, the square patch, as we talked about, we have the one to three-year-old study that we've already completed, the EPITOPE study, and we're in discussions with the FDA on the supplemental safety studies for both of those indications, the COMFORT Toddlers for one to three-year-olds and the COMFORT Children for four to seven-year-olds.
Check mark in efficacy, one to three. Check mark to come. Well, sorry, as soon as safety is successful, but study about to be completing enrollment with results in a year. Two safety studies we're discussing with the FDA, so one of the events that are facing.
That kind of also leads into my, to my next question about the submission of the first two BLAs for VIASKIN . They're, you know, it's on the horizon. Can you just kind of further comment on the differentiated or the different parallel paths of the two age groups and kind of what where we are with timeline and what we may expect?
Yeah.
-coming up?
Can I?
Yeah, please.
So, the beauty of having two separate BLAs, although it was the result of answering the FDA's needs when it comes to patch redesign in the kids four and older, is a nice sort of hedging strategy for us and for investors also. There are two separate BLAs. I don't need the first BLA to be approved for the supplemental BLA to be worth something. They are two separate tracks. The one to three program is slightly ahead time-wise in the four to seven program because safety studies are shorter, six months, easier to enroll. So our ability to complete the safety study that's supplemental one to three is likely to play out before we get to top-line results of the efficacy trial in the four to seven. So the two are sort of back to back.
We have not yet committed publicly to when would be the filing of the BLA, but reasonable math would be that, the safety study being a six-month study, given a certain number of months for enrollment, it wraps us essentially to the path of commercialization taking us in the later 2026 or maybe 2027 .
In regard to alignment with the FDA on COMFORT Toddlers, when do you expect to receive a response on the proposal of the draft submitted in June?
[David?]
Yeah, so we expect to have feedback from them in the next several weeks. There's been really good dialogue. As you know, we are reviewed by the same division that does all the COVID work, so obviously, they've had a huge amount of work, but I think a lot of that is behind them, and we've seen really good interaction with the agency. Again, remember, we are a completely novel product. They've never seen anything like us before. We're not a transdermal product, and so it's taking a little bit of time on both sides to get comfortable with where we are.
It sounds like the toddler age group is going to be likely the first BLA submitted.
Yes. Yeah.
And so, what kind of remains for final alignment to kind of get it across that finish line?
The discussion with the FDA, and I'll set the stage, Pharis providing the details here. The discussion with the FDA around the safety study was to have best characterization of the wear experience, daily wear experience of patients, which can vary from one patient to the other for reasons of patient knowledge, quite simply. The FDA wanted that to be addressed through our safety study. We thought there was a better way of doing it by leveraging very rich data that we have from our efficacy trial, and that's been a discussion with the agency that was formalized with the FDA in late June. We believe that leveraging the efficacy data to identify best responders is a better way to answer the question on optimization of wear experience than generating the data from a safety trial decoupled from efficacy.
We think the FDA is responsive or at least receptive to the argument. That's what should play out the next few weeks here. So once that agreement has come to what is the data the agency wants to round off the dossier, assuming they're okay with the labeling proposal, we'll need to run a safety trial, and that will come with that feedback from the agency. And those trials are easier to enroll, obviously, and shorter to run, so we like to think we move on that pretty quickly. Specifics on that will come once we have communication back to the markets also. Is that helpful?
Yes.
Yes.
And then can you comment a little bit about the kind of classification of Label In versus Label Out and-
Yeah.
Kind of what you guys have learned from that and how you're hoping to kind of maybe apply that to future labeling?
... I'll have Pharis add more detail. We've offered only so much detail on that at this point in time, because until the FDA says yes, and again, where they draw the line remains to be seen, but conceptually, the Label In and Label Out has that certain mark.
Yeah, so as Daniel said, we've always believed that the wear time experience should be viewed in the context of efficacy as well as safety. So we went back to our EPITOPE study, and we looked at every subject in that study, and we looked specifically at the daily wear time. So we plotted all of those subjects out, and what's really interesting is that there are two subgroups. So there's one group, and that is the majority of the patients, who have very little day-to-day variability in wear time. So they get up to north of 20 hours per day very consistently. In contrast, there's a minority of subjects who have high day-to-day variability. So one day they might be at 12 hours or 13 hours, the next day they're up at north of 20 hours, but they jump up and down.
What's super interesting is that when you plot that out for the course of a year, within the first 90 days, nine zero, three months, you can see the differences in the two patient populations. Okay, so what's the big deal about that? When you then look at the efficacy in what we're calling the Label In group, the group that can get to north of 20 hours on average during the course of the study, they declare themselves in the first 90 days, their efficacy response is more robust. Remember, in the trial, we had a 67% response rate. In the Label In group, they're north of that number, so they have a tremendous response. In contrast, the Label Out group, those who don't get to 20 hours and have that high day-to-day wear time variability, have less of a robust response.
There's a clear difference in the efficacy part. And again, what's really important is the more robust efficacy response doesn't come at the cost of a worse safety profile. If anything, there's a slight numerical trend towards having a more favorable safety profile in the Label In group. It's a very pragmatic approach, and if you step back and think about the whole allergen immunotherapy space, the other therapies or immunotherapies, SLIT and SCIT, you'll need at least six months to multiple years before the practitioner can tell whether or not the therapy is working. But in the case of VIASKIN p eanut, in the first 90 days, the prescriber can sit down and have a joint decision-making conversation with the caregiver to say, "Hey, your daily wear time looks really great. You seem to be having a very easy time.
I recommend you continue therapy." Alternatively, if they have high variability, they can have their conversation and try to decide, are there any lifestyle modifications that we can make? And if not, then they can have the alternative discussion, which is, "Well, your wear time isn't quite, you know, as high as I'd like it to be. The data shows that your chances of having a robust response might be less. Maybe we should move on to a different therapy." So I think that approach, being so pragmatic, so simple, so straightforward, would be very well received by prescribers if and when we're approved.
And then thinking towards some of the more recent entrants into the food allergy market, how do you kind of foresee any competition in that regard? Or, you know, how are you thinking about kind of some of the new entrants?
Yeah, the competitive landscape is pretty barren, unfortunately, for parents. Even for us, I think it's not something we should celebrate. Oral immunotherapy in the form of PALFORZIA was approved many years ago. It was not a commercial success, although there's lessons from that are important to import to our product or others. Despite the fact that PALFORZIA was very cumbersome to families, it was recommended quasi-universally by prescribers to families who had a child that was just recently diagnosed with peanut allergy. So the willingness to treat and write a prescription was high, and managed care access reimbursement was also very good. So you have a situation where the product is recommended, the product is being reimbursed, was not a commercial success because the product is cumbersome.
But the core dynamics are important for us coming into the marketplace here, to believe the willingness to treat is high, market access reimbursements will be good. There's another product by the name of XOLAIR that was approved also, which is IgE monoclonal antibody, that is an attractive option for older children, for patients who are multi-allergic, and the best way to manage maybe the risk for them. Not an interesting option for children aged two, three, four, five. You don't want to suppress IgE production across everything in that population, obviously. But the fact that there's more options available creates a dynamic by which parents that go see the allergist, they talk about their child, they talk about the options, and that dialogue is important in market development for us, so we certainly welcome it.
Right. Then, so just as a point of clarification, in the children population, both trials so far have children. We're talking age four to seven, but then there was a couple of trials back, like the REALISE trial, that went all the way up to 11. So when you're thinking about future labeling, what would kind of that age range actually look like?
That's an important question. The labeling will be one to three at the age of initiation, or four to seven at the age of initiation. So you don't have to change patch on your fourth birthday. You don't have to stop therapy on your eighth birthday. So, and that's since it's gonna be chronic therapy, so the labeling will describe patients that started treatment, but no limit when they should come. So we believe it's gonna make for something that's pretty straightforward for parents and for physicians.
You know, just the last couple of minutes, I wanted to talk about what the kind of next catalyst or points of inflection are over the next 12 to 18 months for the platform.
Feedback from the FDA is pretty significant, since it's been the big question that obviously has been around our product here. So that's the next big inflection point and catalyst. We believe that should come within a matter of weeks. Later on this year, we'll be presenting year two of the open label extension, one- to three-year-old. The result was rather remarkable after year two. That should be available sometime later on this year. Then in the fall of 2025 , will be the top-line results of our study for seven-year-olds. So we have three pretty big events set over the next 13 or 14 months, as long as he does his job.
And then anything else that you'd like to speak on before we conclude in our last minute?
Pharis, anything you want to add?
No, I think, we're in a really good place. I'm really happy with the VITESSE recruitment, and, there's a lot of enthusiasm for our product. We had standing room only at, one of our product theaters, and, it's just really, really, a good place right now. Yeah.
Wonderful.
Happy, thank you.
Thank you very much.
Thank you.
Thank you.