DBV Technologies SA at Barclays Global Healthcare Conference

Mar 15, 2017 AM EDT
DBV.PA - DBV Technologies SA
DBV Technologies SA at Barclays Global Healthcare Conference
Mar 15, 2017 / 07:20PM GMT 

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Corporate Participants
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   *  Susanna Mesa
      DBV Technologies - SVP Strategy

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Conference Call Participants
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   *  Geoff Meacham
      Barclays Capital - Analyst

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Presentation
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 Geoff Meacham,  Barclays Capital - Analyst   [1]
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 (audio in progress) -- DBV Technologies. We are thrilled to have you, Susanna. Do you want to say a couple of things to start off the conversation, and we'll get right into Viaskin.

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 Susanna Mesa,  DBV Technologies - SVP Strategy   [2]
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 Sure. I think the next 12 to 18 months are a really exciting period for us. We have about five clinical trials reporting data, starting with our vaccine trial, which is expected in the first half this year, so in the next couple of months here. We also our Phase III for peanut allergies reporting in the next half, in the second half this year, as well as our Milk trial and our EoE trial next year. So, a very exciting period for us.

 And for those of you that are not familiar with DBV, we are the epicutaneous immunotherapy company. We've developed a new pathway for immunotherapy focused on the skin, where we target the Langerhans cells to create a very potent immunotherapeutic agent which we're first exploring in food allergies with peanut being our most advanced asset. And I'm happy that Geoff is our analyst.

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 Geoff Meacham,  Barclays Capital - Analyst   [3]
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 So, let's talk a little bit about the peanut allergy space. Obviously, people tend to look at it as a zero-sum game, and we tend to think about this as having you guys and other competitors are overall good for the -- to build awareness. But where is your -- let's start, Susanna, with the kind of pre-market, like what are the next steps here strategically for you guys ahead of data? And then how do you think about -- we'll talk about the launch.

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 Susanna Mesa,  DBV Technologies - SVP Strategy   [4]
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 Maybe just address your first question. Just in terms of the zero-sum game, of course we don't see it that way. It's a really, really big population of patients that are currently suffering, not just from peanut allergies, but from all food allergies. Just in peanut allergies, we have about 8% of children in the US actually suffering from peanut allergies. So, it is a very broad population that hasn't had a treatment or development in this field for the last 20 years. Pharmaceutical development has been stalled in food allergies because of the safety associated with treatment in this field. So, I think the more products and the more treatments that are available for those patients, the better, the more optionality for them.

 I think the way we see Viaskin is that we see that, because of our efficacy and safety profile, which has been demonstrated through Phase II today, it's a nice standard of care product. And we see that it appeals to the patient because it's easy, because it's safe; it doesn't require a lot of the stress in terms of the age profile. It doesn't require a lot of modifications to the lifestyle. And that helps a caretaker also see it as something that's feasible, as something that helps their child or whoever that patient is. So from that perspective, we see it as something that fits nicely into the physician office, and it also fits well with the practice today, but is not a zero-sum game. Of course, I think the more development there is in the field, the better it is for this patient.

 In terms of our next steps in terms of approval and commercialization of the peanut allergy product, we are, like I mentioned, in a Phase III. It's a global program that encompasses two different trials -- is the PEPITES trial, which is an efficacy and safety trial. That trial is 356 patients, children four to 11 years of age, and it measures efficacy after one year of treatment. So we should have data for that program in the second half, as I mentioned.

 And in addition to the PEPITES trial, we have the REALISE trial, which is a Phase III study. It's a six-month blinded safety study. We don't have efficacy measurements, and it really is to deploy the BLA filing of the product. So once these two trials are fully completed, we will be in a position hopefully to use our breakthrough designation and submit it to the appropriate regulatory agencies in the US as well as Europe.

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 Geoff Meacham,  Barclays Capital - Analyst   [5]
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 Looking further out, though, how do you view, Susanna, the inputs for kind of the pricing equation?

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 Susanna Mesa,  DBV Technologies - SVP Strategy   [6]
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 Sure. So, I think what we've seen so far is that payors are really looking for a product that fits nicely into that patient's life, and so something that's not going to require -- that doesn't have more safety issues than it actually create -- gives to the patients. So far, we've seen really good reception in terms of the payor reception for Viaskin peanut.

 We've provided some initial guidance in terms of pricing for the product. We've said that anywhere between $5,000 to $10,000 is really the range we are looking for for that first initial -- or for each year of treatment. And so far, our market research points to that is something that we can achieve. So we continue probably to believe that that's the right pricing for us.

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 Geoff Meacham,  Barclays Capital - Analyst   [7]
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 Obviously, the pediatric market is the bigger of the population, but how do you guys see the adult population? Are your current trials enough or how would you address that sort of clinically first? And then commercially obviously a different story.

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 Susanna Mesa,  DBV Technologies - SVP Strategy   [8]
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 Yes. I think, for us, the goal would be to be able to treat all peanut allergy patients. Our Phase II data shows that there is a 250 microgram dose of Viaskin Peanut, and for those of you that are not familiar with the food allergy space, 250 micrograms is a very, very small amount. A peanut is 300 milligrams. So, what we've done with Viaskin Peanut is really discover a very potent pathway to treat this allergy. We are treating it with 250 micrograms, and patients are getting sensitized to levels above 1,000 milligrams after three years of treatment. So, it is very potent. But for the adults (inaudible) the adults, we will probably have to explore a higher dose. So that's something that we are going to do in the future. But I think what we've seen is that while it is an important patient population, our market research suggests that the children are really the prioritized population for us, at least right now. We see that in the way that we enroll our clinical trials. They enroll very fast. There's a motivation to receive treatment from the caretaker and from the patient. And at the end of the day, the product fits very nicely in that pediatric population. So, it is something that we are prioritizing, and our Phase III program today is in patients four to 11 years of age. And actually, we recently confirmed that the FDA has given us the green light to go into a Phase III trial of patients one to three years of age, which is actually very surprising to see that the agency is okay with us going straight into a Phase III into that young population, which, for them, is very delicate and it has to be very well-treated because of the safety issues that may arise. So we are going straight into one to three years of age, and that is starting in the next couple of months here. So, we will have the full children, pediatric side of the equation covered. And I think, once we get the results from the Phase III in this initial four to 11 patients years of age, we will be able to provide refined guidelines -- guidance in terms of when we intend to go into adults and the adolescents. And it is something we want to explore. We are already working with our medical team and testing higher doses to see if there is a correlation between the dose and the body surface, or if there is a correlation between the size of the patch and the response of the patients. So we are doing all of those studies in-house right now to optimize the treatment when the time comes, when we go into this older population. But at least, for today, we are really focused on the pediatric population. We believe is the prioritized population in this disease.

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 Geoff Meacham,  Barclays Capital - Analyst   [9]
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 So higher dose and it builds bigger patches possibly?

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 Susanna Mesa,  DBV Technologies - SVP Strategy   [10]
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 Possibly. I think we've seen some correlations between both. As you know, Viaskin targets the Langerhans cells, and so when you are older, the Langerhans cells are more spread out from each other. And so what we've seen is that if you increase the size of the patch, you may be able to capture more Langerhans cells for the older patients.

 We are a science-driven company, so we like to first and foremost sift everything into the clinic, look at our animal models, make sure that we have a really scientific and solid plan forward before we actually jump into humans. So, we are looking at all those different things in the lab first, and then hopefully, by the time we have the results from the Phase III, we will provide a refined guideline on when we would be able to move into the older patients.

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 Geoff Meacham,  Barclays Capital - Analyst   [11]
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 You can leverage potentially a bigger patch for other food allergies like milk, or do you want to stick with the same size patch you think (multiple speakers) in the pediatric population?

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 Susanna Mesa,  DBV Technologies - SVP Strategy   [12]
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 It depends for -- it depends on the type of the formulation that we use for the antigen that goes into the patch. So, for example, if I think about the milk, the protein formulation is a little bit different than the peanut. Milk protein tends to be a little bit more unstable, and it's actually very difficult to formulate. So it was an accomplishment to actually get it done. And so the patch itself has to be a little bit thicker just to be able to keep that protein intact. So if you look at the milk patch, it's just a tiny bit bigger, but we are talking about very minute changes here. So I think, for the children, we are very comfortable with the size and dosage today, at least for where we are now, and then again in the future as additional changes need to be made for the older population, so that is something we will explore.

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 Geoff Meacham,  Barclays Capital - Analyst   [13]
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 It's really a very interesting platform and mechanism for other allergies. And so if you have sort of a laundry list of what -- based on the literature, based on scientific evidence, like what beyond peanut and milk, is there anything mechanistically that you can say this should be particularly robust? I know you're studying for (multiple speakers) antigens essentially.

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 Susanna Mesa,  DBV Technologies - SVP Strategy   [14]
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 Yes, so, I think, again, for those of you that are not familiar, the way that Viaskin works is that we are able to capture an antigen into the backing of the patch, which is electro-magnetically charged. When you apply the patch onto the skin, it creates a condensation chamber that allows the antigen to dissolve. And when it dissolves, the Langerhans cells actually migrate to the top of the skin, grab that antigen and migrate to the lymph node to activate the immune system. And because of the antigen, and usually here being a protein for example with food allergies, it's too large to pass into the bloodstream, the response is actually centralized in the lymph node and it doesn't go into the bloodstream, which is what allowed us to go into food allergies, because we are not creating systemic responses.

 And so as we continue to discover a little bit more about this new technology, epicutaneous immunotherapy, we saw that it has a very nice profile for treating diseases in other immune disorders as well as inflammatory disorders. And so, today, that's really our prioritized pipeline, its goals. And one of the products that we are investigating today actually in a pilot Phase II study is actually eosinophilic esophagitis, which is really almost an inflammation of the esophagus. And so we are looking into that, and the animal data looks really, really nice.

 As you mentioned, we also look into vaccines, so we do have a vaccination platform within the Viaskin platform that's currently ongoing. We have proof of concept Phase I data in humans coming on in the first half of this year for (inaudible). We are also looking into RSV vaccination, and we've had a couple of nice preclinical presentations in a couple of different medical meetings over the last few months. And in addition to that, we've looked at a couple of different indications again in autoimmune and inflammatory diseases, including diabetes 1. We looked at celiac disease. We looked at a couple of other indications that seem to fit really nicely for the patch, both because of the efficacy being concentrated in this lymphatic area with the Langerhans cells activating the immune system, but also because of the safety, again, because we are not allowing that antigen to pass into the bloodstream and you are not having the systemic reactions that you see when you inject something, when you take something orally, when you take something sublingually. It's a very unique platform in itself.

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 Geoff Meacham,  Barclays Capital - Analyst   [15]
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 So maybe if we can just go back to peanut for a few moments, at last week's Quad AI meeting, you presented some updated long-term data on peanut, a smaller study, not as of course big as your upcoming Phase III trials here. Can you maybe just walk us through the data and what the long-term safety and efficacy seem to show in this population and maybe some of the differences between what's in the Phase II trial just from a design perspective or eligibility and so forth type criteria and how we can use that as a proxy for what will be obviously very important data in the back half of this year?

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 Susanna Mesa,  DBV Technologies - SVP Strategy   [16]
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 Sure. Quad AI was an exciting year for us -- an exciting meeting for us. We had eight presentations total, so it was good to see that the presence of DBV continues to be very marked at this congress, which is the landmark congress in allergy. We had a latebreaking presentation that showed that patients that have been treated with Viaskin for 36 months of treatment to three years of treatment with 250 micrograms are able to maintain their response, but also progress with time. So, what we see is that there is a natural progression that occurs as the patch is worn for longer. So, from year one, where we went for -- from some 53% response rates in children treated for one year with Viaskin Peanut, we went to 83% after three years. There is a significant increase in the number of responders that we are seeing from year to year. And you can see that also by the second metric that we use to evaluate efficacy, which is not the primary endpoint, but it's called the commuter reactive dose. And it's the addition of all the different stuffs in the food challenge when you look at the overall consumption of peanut protein during the trial. And you can see that it tracks very nicely. And by the end of three years, you have patients going all the way up to 5,000 milligrams, and you have other patients going to 1,000. And so it's a very robust response profile that's also marked by the change in the biomarkers that we are looking at. So I think, for us, it was exciting to see, one and foremost, that we can maintain that response with the exact same dose that we've using after one year. So there's no additional dose escalation that need to be made. You are able to make that long-lasting, sustained response year after year, but in addition to that, we see a progression in the number of patients that are benefiting. And what that tells us is that, in real life, there's patients that are simply going to need not one year but maybe three, maybe four, maybe five, maybe six. We've seen in different immunotherapies that it depends on the patient. And so what this tells us is that there is an opportunity for additional responders to occur after year one. But I think, again, after capturing the fact that the response is sustained, it is exciting to see that additional responders as well as increase in the overall consumption of peanut is achieved after three years.

 Most importantly, I would say the safety continues to look really favorable. We still see no SAEs related to treatment; we see no epinephrine due to treatment. And even though the patient had been going on at this trial for three years switching the patch, monitoring the change of the patch and recording it in diaries, taking them to the physician, even though we see all of those kind of burdens that are not what you would see in real life, we still see the compliance continues to be above 95% after three years of treatment but the dropout is very low. And so we are seeing and are encouraged by the different types of metrics that we are gaining from this long-term trial to help us understand how the products will be used in real life.

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 Geoff Meacham,  Barclays Capital - Analyst   [17]
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 Sure. And then as a potential proxy for the data, if you could maybe just highlight a couple of the key differences, if any, that you would note between the data at Quad AI and just the kinds of kids who are enrolled in your Phase III trials?

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 Susanna Mesa,  DBV Technologies - SVP Strategy   [18]
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 So, I think, overall, Quad AI was three years of treatment, and we will have our endpoint at year one of treatment for the PEPITES trial. So, it will be, I would say, probably more representative by looking at the baseline population at the VIPES trial, which is our Phase II program that we were just discussing.

 So, you know, we haven't provided the VIPES characteristics publicly for the Phase II program, but what we said is that they are very similar to what we saw in the children population for VIPES. And that's because the patients that we are enrolling in our trial, which exclude patients that are reactive above 300 milligrams of peanut, which is about one peanut, it's pretty encompassing of the full peanut allergic population. So, we want to be as broad as possible in terms of the types of patients that are benefiting from treatment. So, today, for PEPITES, we believe the population is going to be pretty reflective of the children population in VIPES.

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 Geoff Meacham,  Barclays Capital - Analyst   [19]
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 Okay. Just with respect to the long-term data that you guys saw at Quad AI, is this perhaps maybe a post-marketing type of design where you looked at -- because there's just an open question about the maintenance component of it is not really -- but it could lead to a very long duration of therapy in the real world though. So what are some of the range of options that you would think about when it comes to let's say analyzing that?

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 Susanna Mesa,  DBV Technologies - SVP Strategy   [20]
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 Sure. I think [ALSAS] is done, so it is three years. It's done. It was to study the long-term efficacy and safety. PEPITES, which is a Phase III, will also have a three-year program that's an extension trial, and that will most likely be more post-marketing, kind will gain information that will help up us understand the duration of the treatment, that will help us understand how patients are using it in real life. And that's actually one of the reasons we invested in launching our REALISE trial, which is this other Phase III that I spoke about earlier, because it helps us understand how patients are using the product in real life and how the doctors are interacting with the patients. And so there are going to be some metrics that will be taken out for this trial. The endpoint is at year one, which is customary for most immunotherapies. You can't have a placebo patient for three, four, five, six years. But I think what we learn from (inaudible) which is the extension trial and how it correlates into the real world, the most important lesson is the fact that the response is maintained, but it's progressive. And so it's progressive in the sense that it's going to be very variable from patient to patient. And today, we see that that's what is so neat about Viaskin, is that, in some way or another, it allows us to be a personalized product that allows the patient to achieve a relative risk reduction based on his or her specific threshold in the evolution of that disease over time. And that's exactly what it also showed, is that, with time, those responses change from patient to patient. And so it's neat for the physician to be able to work with the patient directly and the caretaker to see the evolution of that disease after two, three, four, five years of treatment.

 Now, one of the things that we are seeing today is that there's going to be some patients that are simply not going to want to go off therapy, and they are going to want to use Viaskin as a chronic treatment, and that's why it's important to show that, even without a different dose, they are still maintaining that response right, so that, if that patient decides to continue wearing the therapy for the rest of their lives, they're going to be able to be protected with (inaudible). There's also some patients that after three years of getting for example 5,000 CRD, which is what we saw in our ULTA trial for three years and they may say now I want to reintroduce peanuts into my diet. And so that patient may work with a physician in reintroducing peanuts into the diet slowly, and to a point where he can then be of therapy. So I think, today, the endpoint of the trials and the objective of trials today is to provide patients with a risk reduction to accidental traces of peanuts. So you want to reduce the risks that are associated with the traces exposure. But what sustain of responsiveness may look like in the real world, and by sustain responsiveness I mean patients being off treatment, that today is unknown. And I don't think the FDA has provided us with guidance on how they looked at that. And so today, we have to just go off with what the FDA has guided us to, which is achieving the right risk-benefit for a product that can be approved, that it can be effective in real life because patients like it, because they are using it, because they are not dropping off because it doesn't have an innate profile that makes it almost unusable, and be able to at the same time provide them with the safety and efficacy. And that's how you come to a risk-benefit profile that really allows for a therapy to treat patients in the real world.

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 Geoff Meacham,  Barclays Capital - Analyst   [21]
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 Susanna, thank you very much.

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 Susanna Mesa,  DBV Technologies - SVP Strategy   [22]
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 Thanks everyone. Thanks for joining us and for those of you on the webcast.




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