Kim and Commins discuss what the next series of data on the investigative peanut immunotherapies may mean for the field.
What might be the best outcome from new peanut allergy immunotherapy trial data is the next round of research it allows. Though the US Food and Drug Administration (FDA) will rule on the marketing application of at least 1 potential first-generation immunotherapy in 2019, a pair of researchers at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2019 Annual Meeting in San Francisco, CA, considered what lengthier trial results would show in different peanut-allergic patient groups.
In the next segment of an interview series with MD Magazine®, Edwin Kim, MD, MS, and Scott Commins, MD, PhD, colleagues from the University of North Carolina School of Medicine, discussed the newest findings for AR-101 and Viaskin Peanut—as well as their own investigative work to understand the post-treatment life of a peanut-allergic patient.
MD Mag: What are your thoughts on peanut therapy candidates AR-101 and Viaskin Peanut?
Kim: I mean, of course we're really excited to see where these treatments go, and at this point, understanding that the FDA is actively looking at AR-101 as a possible treatment. And we're waiting for Viaskin to be resubmitted to the FDA. And I think it will be exciting.
I will say, sort of from the clinical allergist point of view—coming back to this theme of patient choice, it is going to be very important. It would be really nice to have multiple options, because it probably is not a one-size-fits-all when it comes to peanut-allergic patients.
Commins: I wonder. When you look at the data, sometimes they don't hit their pre-subscribed primary endpoint. But even within that, it seems like there are signs of efficacy, and maybe it's like, the next studies are really the ones where we start to get a better sense of—as we talked about before—the personalization.
And so you have this top-line data, but maybe what we really want to see, as you mention, is that next set of studies.
Kim: I totally agree with that. And in particular, I think when I look at the DBV data, you have to wonder, based on the phase 2 studies, of whether it just takes longer. The phase 2 seem to suggest year 2, and year 3 perhaps there was a stronger efficacy right there, or a responder rate. And obviously the study that was just published that only shows that first 12 months.
I do know that they have ongoing safety and efficacy studies that are ongoing, so it would be really interesting to see what that that data shows.
Commins: Do you have a sense that that we're going to keep looking younger and younger?
Kim: I do. You know, I think at this stage, the data from all different modalities—oral, epicutaneous, even sublingual—seemed to suggest not that it can't work in older populations, but seems to have a stronger benefit in younger populations. In particular, when you think of something like oral, it seems like it might be better tolerated in the younger groups. And then if you kind of add on top of that another layer of this whole idea of early introduction, we're going to be likely diagnosing people with peanut allergy much, much, much earlier.
So I think it'll sort of just come hand-in-hand, where we're going to be treating younger at this point. I think it'll be really exciting to see both companies—my understanding is they have studies in that younger age group, age 1-4. So, it'd be really interesting to see what that data looks like as well.
Commins: And then the other part of what we do, sometimes day-to-day, is think about equivalents. You've been dosing with powder for a while, but then how do we get you to a real-world solution? And I think the other thing that that concerns me is, what do we do with our teenagers? I mean, how long are you going to continue to eat candy and not hide it in the closet?
Kim: You know, it's a really nice segue into one of the abstracts that we were able to put together of what is life like after immunotherapy. Again, it looks like the data suggests that you can increase that threshold and protect them, but are they going to do that forever? What is the real-life outcome of this?
So, our abstract tried to show we had patients, even up to 8 years after finishing their immunotherapy trial—many of them had introduced some peanut food into their diet. Like you suggest, maybe it's a candy. Maybe it's peanut flour that they get at the store. Whatever it might be, it seemed to show that many were actually able to do it‚ which I think is important on multiple levels. One of them is just being able to open up the diet a little bit, maybe relieve some of that anxiety that inherently comes the allergy.
And then perhaps, that's also a way to kind of maintain that benefit that they got from the immunotherapy, as well. That might be especially important when we get into those teen years, and when they're ready to leave the home and it might be harder for them to do a treatment when they're out of the family environment. So perhaps this is a way that they maintain stuff.