FAACT's Roundtable

Ep. 204: Exciting Updates from AAAAI 2024

• Shahzad Mustafa • Season 4 • Episode 204

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Learn about ground-breaking news and updates from the recent American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting held this February in Washington, D.C. In lay relatable terms, FAACT’s Medical Advisory Board Chair, Dr. Shahzad Mustafa, discusses the approval of Xolair and what it means for the food allergy community. He also shares his thoughts regarding treatments that are on-the-horizon for anaphylaxis from ARS Pharma, Bryn Pharma, Aquestive, DBV Technologies, and Blueprint Medicines.

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Caroline: Welcome to FAACT's Roundtable, a podcast dedicated to navigating life with food allergies across the lifespan. Presented in a welcoming format with interviews and open discussions, each episode will explore a specific topic, leaving you with the facts to know or use. Information presented via this podcast is educational and not intended to provide individual medical advice. Please consult with your personal board certified allergist or healthcare providers for advice specific to your situation. Hi everyone, I'm Caroline Moassessi and I am your host for the FAACT Roundtable Podcast. I am a food allergy parent advocate and the founder of the Grateful Foodie blog and I am FAACT's Vice President of Community Relations. Learn about exciting news and updates from the recent American Academy of Allergy, Asthma, and Immunology Annual meeting held this February in Washington, DC. In lay relatable terms, FAACT's Medical Advisory Board Chair Doctor Shahzad Mustafa will discuss the approval of Zolair and what this means to the food allergy community. He'll also share his thoughts regarding on the horizon treatment treatments for anaphylaxis from ARS Pharma and their intranasal spray called Neffy, Bryn Pharma and Aquestive Therapeutics, plus Blueprint Medicines regarding systemic mastocytosis and DBV Technologies. Regarding the peanut patch before we start, we want to highlight FAACTs National Gold Sponsor, the National Peanut Board, and thank them for the years of continued support and partnership.

Caroline: Welcome, Doctor Mustafa, to FAACT's Roundtable podcast. You are a fan favorite. Thanks to your warm and easy to understand style. Everyone just waits to hear you speak. So, we're all excited about today's podcast, and we're absolutely just delighted that you were going to share with us today the exciting news and updates from AAAAI.

Dr. Mustafa: Thanks, Carolyn. It's fun to be here.

Caroline: Well, again, we're absolutely ecstatic you're here. And so we have a lot to discuss today. But let's get started with your background, if you don't mind sharing with listeners, and if you don't mind focusing on why you relate to our community just a little differently than most doctors.

Dr. Mustafa: Yeah, so I do. I practice allergy immunology in Rochester, New York. I see kids and adults. We have a practice that sees everyone. I actually have a little research interest in immune problems due to cancer and chemotherapy, so that's pretty different. But our other real research interest in our practice, because we take care of so many individuals with food allergy, is considerations of quality of life and the management of food allergy. I'm not sure what makes me a little different. It might be that my eleven year old guy has peanut allergy, peanut cashew and pistachio allergy. So that actually happened after I was already in practice. So, as you guys, some of you may know, I'm very try to be evidence based, scientific, but I appreciate that sometimes it's hard to translate the science when feelings and emotions and, you know, family gets involved. So I think that's given me added perspective to this stuff.

Caroline: Oh, it definitely does. I know I hear from people after they've listened to your podcast or heard you speak, that they really feel that you understand that emotional aspect and the steps that they walk through. And they appreciate that you bring that into your medicine and you bring that into our podcast and everything else. So thank you so much for sharing who you really are.

Dr. Mustafa: Yeah.

Caroline: So now, turning to the big news announced at quite a can you explain what does the approval of Zolair for food allergies mean to our community? And then, if you don't mind just touching about how the process goes in terms of approving a drug, because this has been a really long process.

Dr. Mustafa: It has been a really long process. Interestingly, and this was presented by Doctor Bob Wood in our AAAAI, the big meeting in Washington, DC. The first big paper on Zolair, which the brand name is Omelizumab, oral anti Ige. And very simplistically, Ige is our allergic antibody. So if you block Ige, you would suspect you have less allergic reactions. And that does play out to be true. Zolair was first came to market for asthma in 2003. Carolyn, allergists thought we'd be out of business, because if you block your allergic antibody, right, there won't be any allergies. Well, turns out the human body is super complicated. But also in 2003 was the first paper published on zolair and food allergy, and it showed what this paper shows. The difference is this paper was very rigorously done at multiple sites with multiple food challenges. It's a very complicated study with multiple phases. And as of right now, only the first phase has really been reported out. And it's the first phase that led to FDA approval. A little background. There's been a lot of small studies that suggest zolair can be used to manage food allergy. But the difference for this one is, again, it was rigorously done at multiple sites with multiple food challenges. So it's a little bit more hard and fast data that is necessary to change a label and how the FDA works in America. It's a very high bar to get things changed on label. And the study was able to do that. So as of last weekend, Zolair is FDA approved for the management of food allergy, any food allergy or food allergies in individuals one year of age and older, which is wildly exciting. It may change the entire landscape of food allergy management in our specialty, and it comes with more questions than answers.

Caroline: Isn't that how everything is in life? So now, for the average person just listening, what would they do right now? Like, do they go to their doctor and say, am I a candidate? Does my insurance cover it? What are the side effects? Like, what would you do right now if someone walked into your practice?

Dr. Mustafa: Yes, I think right now is going to be an exciting time of raising awareness. As people start to learn about this, I guess we need to learn about what it means. Right. So the indication and the label says Zolair is supposed to increase the amount of the allergen that it takes to cause a reaction. I think that's important. The design is not to make you unallergic. And as of today, the goal is still continued avoidance of the food. It is not consumption of the food as of today. Now, this might change. Zolair is really a huge safety blanket as you continue to avoid your food allergen. But if you were to have an accidental exposure, it would be unlikely to cause a reaction because the medication has increased the amount of food it takes to cause a reaction. I think that's important. That's where we're at today. That may change over time. In parts of this study, which is called the outmatch study, there's phases to it, and the third phase is actually trying to introduce foods under the umbrella of Zolair. But as of today, it's continued avoidance and protection from reactions with accidental exposure. Still carrying epinephrine. The beauty of Zolair is it's been around for 21 years, Carolyn. Right. It's been FDA approved for asthma. It's FDA approved for asthma in kids six years of age and older. We've seen studies in food allergy dating back two decades. We have a long history with it. It is fantastically safe. It is still a medicine. You still have to think about side effects. But the side effects are very similar to placebo. That's a huge privilege. It's a very safe, well tolerated medication. I think it's unique from other medications about the safety being as good as it is. And it might be very, very different than other food allergy therapies. Many individuals are familiar with oral immunotherapy which has many side effects and considerations. You know, there's no head to head studies yet. That's part of this outmatch as well. But Zolar is almost certainly better tolerated than oral immunotherapy as far as side effects. So it works to increase the amount of food it takes to cause a reaction. It's well tolerated. It's an injection. It's an injection every two to four weeks, depending on your dose. You start off in probably a healthcare facility, but can likely do the injection at home eventually self administered. And for individuals who have IgE mediated allergies, not intolerances, not sensitivities, not FPIES, this is a treatment option, and you should discuss it with your healthcare team.

Caroline: Now, you might not know the answer to this one, but do we know anything about insurance? And is this considered a difficult thing to get covered?

Dr. Mustafa: Yeah. So I definitely don't know the answer to that one. We have six kind of injectable medicines and allergy these days for different reasons. For hives, for eosinophilic esophagitis, for asthma, for atopic dermatitis. These are highly effective, safe medications, but they're called monoclonal antibodies, they're injectables, and they tend to be more expensive. So there are more barriers for insurance coverage and prior authorizations. A practice like mine has a full specialty pharmacy, Caroline, dedicated to doing that work alone, getting these medications approved because it is so important, because they have changed how we practice allergy these days. So it's going to be a learning process. I mean, this just happened, right? So insurance companies and all this stuff going to make policy. So it's really hard for me to speak to that. But at the same time, it's literally the only FDA approved product for management of food allergy there is. Palforzia peanut oral immunotherapy. But that's just for peanut, and that's just age four to 17. Zolair is not food specific. It's any food, and it's over the age of one. So I can never predict what insurance companies are going to do. But in a space where there's unmet need. Right, Carolyn? We don't have many therapeutic options, and now we do that one that's been proven to be effective and safe, I certainly would hope, and actually, I would honestly expect it to get coverage. There may be some criteria for that, but I expect it to be available for this use.

Caroline: This is really exciting. I actually remember when my son was in preschool, and he's 25 now. Learning about TNX 901 and writing my first advocacy letters know in support of this kind of research. So it was pretty amazing to get the news this last week. Like, this has been a long and exciting journey and it's not over, but this is amazing.

Dr. Mustafa: Yeah, I think this is an inflection point. It has been a long journey. I think it may just be starting in many ways because, like I touched upon, the goal right now is to increase the amount it takes to have a reaction. But there's other phases of OUTMATCH, and the second phase is actually comparing Zolair to oral immunotherapy. How exciting is that? So trying to see which one is maybe more effective or better tolerated. And the third part of it is in individuals with food allergies, really having them start to ad lib, consume their food allergen under the protection of Zolair. Again, this is where a lot more questions than answers come up. And we have a lot to learn and we're going to do that over the next coming years. And OUTMATCH, as great of a study as it is, and I'm working off the top of my head here, I think there was 155 subjects in the study. It's a pretty small number. We're not talking about thousands of people or 500 or, you know, it's a pretty small number. It is a very, very well done, well designed, tight study. It's hard to poke holes in it, but it's a pretty small amount. And, you know, just talking roughly, Carolyn, in the study, Zolair was able to increase the amount of food allergen for about two out of three to 70% of individuals, which is fantastic. That's great. But where does the scientist brain go? What about the other third? So everyone is not a responder. There are people who, before Zolair and after 16 to 20 weeks of zolair, did not change their threshold dose or the amount of allergen it takes to have a reaction. So the question becomes, what makes them different? And, oh, by the way, food allergy is not like asthma or eczema. You can't see or feel the improvement, right? How are you going to know?

Caroline: It's a good point. You're right.

Dr. Mustafa: I can't talk about this, you know me without talking about the importance of getting the diagnosis right. So it's always been important, but goodness, now with therapies that are potentially indefinite, therapies with expensive medicines, we have to get the diagnosis of food allergy, right? And we have to know that positive blood work or skin testing does not make you food allergic. So we really, really, really want to have the diagnosis right, and we should be considering more food challenges than ever before, not only to make the diagnosis, but potentially to do a food challenge once someone starts Zolair to see if it actually is helping them or not, because the only way to know is exposure to the food. This is very complicated. I'm not even sure how we're going to handle it in our own practice yet.

Caroline: Well, it's exciting, but thank you for bringing up, you know, the challenge and food challenges and diagnosis. I think that's really huge because, you know, I confess to even my kids are balking at having to continually do challenges. But in college, you need to know what's going on. And especially, like you said, if new treatments are coming, we really need it. So thank you for bringing that up, but very exciting. I'm sure we'll have more conversations in the future about Zolair. So I really appreciate you updating us on that and in lay terms, so we all can understand. That's what we love about you so much.

Dr. Mustafa: Thanks so much. Yeah, it's absolutely. It's. It's thrilling. It's a needle mover. In our specialty, changes like this don't come along every day. And for individuals with children, family members themselves with ige mediated food allergy, certainly discuss this with the healthcare team. It's an exciting time.

Caroline: Excellent. Thank you. Now let's turn our attention over to new treatments in the pipeline for anaphylaxis, for the actual allergic reaction. So let's start with Neffy, the intranasal spray. And if you don't mind explaining to our listeners, what is it and what information was presented at AAAAI that has direct impact or even meaning to our listeners, like, what is going on with Neffy and what does it mean to us?

Dr. Mustafa: Yeah. So that's a company working on intranasal epinephrine. Epinephrine, as we all know, comes in an intramuscular injection for the treatment of allergic reactions. And this company is working on an intranasal spray that can deliver the same medicine in a different way and have similar characteristics and hopefully, treatment outcomes as the intramuscular injections. Obviously, injections have a high bar. People get nervous to use it. There's anxiety related to it. So the thought is a nose spray or nasal spray, maybe someone may be more likely to use it or better tolerated than an injection. The medicine is the same. It's just a delivery system. And interestingly, doing studies on epinephrine you can't really cause people to have anaphylaxis and then use epinephrine. That's frowned upon. So a lot of the studies are just on blood levels, vital signs, things like that. And the early returns are that it looks like it has similar benefit to injection epinephrine. There's subtleties to it that the company has to work through and other companies that are working in this space, but it's, again, it's exciting expansion of choices. Right now, there are no choices. The only choice is different devices of injections for epinephrine. It would be nice to have different choices, and then it doesn't have to have one choice for you. Might be a different choice for someone else, but choices are always nice.

Caroline: Well, thank you. And I want to make sure listeners know that these products that we're discussing now have not been approved. And so these are all in the studies and in the process. So on that same note, with the intranasal spray type solution, do you mind just touching on Bryn Pharma because they're in that space, too.

Dr. Mustafa: Yep. Different company working on a similar product, intranasal epinephrine. There's subtleties that are different between these products, between the two companies, but the overall idea is the same. I think the device is a little different. I think one. I'm forgetting which one, I apologize, is people have heard of Narcan, right? Narcan device. I think one essentially uses a similar device. The other one uses a little bit of a different device, but the concept is the same. It's a nasal spray for epinephrine to treat anaphylaxis. And there are subtleties there in similar points of development along the process with FDA approval and stuff, but a little bit off there. But at the end of the day, it's going to be a relatively similar product that comes out with subtleties of using intranasal. And I'm sure you'll talk about the next other form of epinephrine, which is not injection or intranasal, but sublingual.

Caroline: Actually, yes. Yes. And before you pop over to there, I just want to mention that Brynis the one, that the device is a little different. So it's not the Narcan one, but I believe it has two doses.

Dr. Mustafa: Yes.

Caroline: As a parent of a patient, this is so exciting to think that we can have these choices.

Dr. Mustafa: Yeah, choices are always great, even if people decline choices that just the option of having choices improves patient quality of life reports, things like that. But subtleties. Many people with food allergies have environmental allergies. They're working on making sure that these medications, these nasal sprays, are just as effective if someone has a stuffy nose or environmental allergies, things like that, things that may not come to mind right away. These companies are doing great work to bring these products to market. I'm confident they will.

Caroline: Oh, so exciting. So exciting. So, yes, now please talk about Aquestive and what they're doing that is totally different.

Dr. Mustafa: So that's totally different, yet it's the same. It's also delivering epinephrine, but in a different form. It's delivering it with a kind of a film that kind of dissolves in your mouth. So different. Not a spray, not an injection, not a pill. So that's through a film that's not quite as far along in studies. Again, a lot of the studies are going to be done on the kinetics of the medication, what it does to how quickly it absorbs, how quickly it washes out, what it does to vital signs, things like that. But the goal, again, remains the same. It's treatment of allergic reaction just with a different form of epinephrine. It is still epinephrine. The base, the foundation remains the same.

Caroline: It's all on the delivery. But you know what? If we've waited this long and we're here to witness zolar coming out, this is fine. We have patience. We've proven it. Yeah, we will be there. And so now give us a quick update, if you can, about DBV and the Patch and where that is.

Dr. Mustafa: Yeah. So again, DBV is a company that's been working on epicutaneous immunotherapy. There's allergy shots for environmental allergies, there's oral immunotherapy for foods, there's sublingual drops for food allergy and even environmental allergies. Epicutaneous is the peanut patch. This is DBV, which has excellent primary literature on how effective it is in increasing the amount of peanut it takes to have an allergic reaction. It's a very small amount of peanut that's introduced to the skin, but it absolutely increases the amount that it takes to have an allergic reaction for an individual. It's been shown in very young kids. So the primary literature, the science is great. DBV continues to work through the drug approval and the FDA process, and they're still working through that. So they are also not yet FDA approved. They've had a long journey. I'm confident they will get FDA approval and this will be a treatment directed just at peanut, not just any food. So that's different than Zolair. And what's different than OIT is if OIT is direct ingested peanut. And the Peanut patch through DBV, epicutaneous immunotherapy is direct just at peanut. How do you do it? Right. Daily doses versus a sticker side effect profile. How much protection you get. There's going to be so many discussions. So we've gone from a world of avoid your food allergen and carry epinephrine injection to, oh, avoid it. But maybe you can use an injection or oral immunotherapy or maybe soon, one day, epicutaneous peanut patch. And, oh, by the way, you don't have to have an epinephrine injection. Maybe you'll have a nose spray or a film. We've gone from pretty limited choices to soon to be more and more choices, which is fascinating and exciting, and we have a lot to learn.

Caroline: Well, for those of us that are older here, it feels like to me the moment when the flip phone came out, like everything just started to change, right from having our little flip phones to now these amazing little computers in our hands. I kind of feel we're right at that moment. It's pretty exciting. And so now there's another company that I'd love to discuss, blueprint medicine year with a new drug release and advances in mast cell disease. And they focus on systemic mastocytosis. So if you don't mind touching on this for our patients who live with these mast cell related conditions and what's going on with Blueprint Medicines.

Dr. Mustafa: Yeah. So they've developed a medication for mastocytosis, which is a pretty uncommon condition where you have increased mast cell activity. This is different than things like mast cell activation syndrome. Essentially what their medication does is it kind of blocks the release of mediators from the mast cell, like histamine and other things. So it's FDA approved for mastocytosis. This type of medication is being and has been studied in numerous other disease states, Caroline, even like asthma, hives, urticaria. So again, it's an exciting time, relatively well tolerated medication that has been proven to be effective. And I think, I'm not an expert in this, but blueprint medicine is really in its infancy and it's growing. There's a lot of potential here and a lot of work being done in this space as well. So, again, expanding therapeutic options for conditions that have historically had very few. So, very, very exciting.

Caroline: That was just a lot of great news about new medications and treatments in these companies. But overall, what are some other highlights that you might want to share with our listeners from AAAAI? That is a giant meeting.

Dr. Mustafa: It is a giant meeting. I think it's a great time. I mean, some of the most stuff I get out of it is interacting with colleagues, networking, catching up with old friends, having conversations, the water cooler conversation, the conversation over a drink, because it can lead to wonderful ideas of collaboration. Right. There's been so many advancements in our field. I think a small but important one is getting away from albuterol for asthma. That comes up. Right. We're really starting to get away from albuterol from asthma. And in adults 18 and over, there's an FDA approved product called budesonide albuterol. The brand name is Air Supra, which is now the rescue medication of choice. I mean, think about not treating asthma with albuterol. And we're starting to get there. We're really, really, really changing the paradigm of how we treat asthma. So I think that's an exciting shift that's happening in our field right now. And then certainly just approaching all these new therapies and different disease states. We have six injectable medications for in our field that we use for a variety of indications right now, and those indications are changing and growing. Many individuals in our field, you know, we see a lot of asthma, but we don't see so much COPD emphysema. Some of these medications that we currently use in asthma may have effectiveness in COPD as well. How exciting is that? That's a huge population in America that remains underserved in some ways. Our therapeutic options are limited. So a lot of exciting time. I give quite a lot of credit. They had a full track dedicated to the basic science. I'm not a scientist, I'm more of a clinician, but this was a full track of sessions dedicated to basic science, which really, that's where this all starts. Amazing people doing work at the bench research level, which then translates to medications and our patients. So I give the quad a great kudos. I think it was called a discovery, forgetting the name now. Goodness. But it was a special dedicated pathway towards, through the meeting dedicated to basic science research. They did a great job of fostering that and had great turnout.

Caroline: There is so much that goes on at that meeting. I feel like when you look over the building, you're just going to see this big brain cloud, like just all these thoughts and ideas and information just being translated. And it's really kind of fun too, being at AAAAI, because FAACT has a booth there, is seeing all the doctors and physicians from all over the world come and end here.

Dr. Mustafa: We met so many international meeting.

Caroline: Very. So it was really exciting to see that huge collaboration.

Dr. Mustafa: Yeah, it's definitely an international meeting. And next year's AAAAI meeting is in San Diego. It's combined with the World Allergy Organization, so it may have even more of an international feel.

Caroline: That's fantastic. So before we wrap up today, is there anything else you want listeners to hear from you?

Dr. Mustafa: No, I think it's an exciting time in our field. We've had a lot of new therapeutics in the last few years and it's only going to continue to expand work with a wonderful allergist that keeps up on this stuff that you have a good rapport with, that you have a good feel with, that you can have a conversation, because there is no algorithm to how we treat this stuff. A decision for one family, one patient may be very different for someone else, and that's perfectly okay. Even in food allergy, it's very important to realize that strict avoidance and carrying epinephrine is still a very appropriate option. Everyone does not need to be pursuing these new therapies. These new therapies are great for some people, but that option still is perfectly appropriate. So I don't want that to be lost. And sometimes when you work with these families, it's almost like I feel guilty someone else is doing something, but I'm not. No, no. I think that the beauty of shared decision making is really important. We just finally have choices. It's great.

Caroline: These are incredible words of wisdom. Thank you so much again for your time. Doctor Mustafa. I can't wait to talk to you again to hear about more updates and just to hear again your fantastic perspective. So thank you so much for your time.

Dr. Mustafa: Thank you so much for having me.

Caroline: Thank you for joining us today on FAACT's Roundtable Podcast. As reported earlier this week, there was a death due to anaphylaxis. Disney Springs, located at Walt Disney World Resort. A New York University Langone affiliated physician lost her life after eating at a restaurant where the food allergy community often considers the safest place on earth for dining out. Of course, this is devastating news and there's so many questions, no one has all the facts. But there's an added fear now that if this happens at the safest place, how can anyone dine out safely with their food allergies? We all know it's about education and communication from the front of the house to the back of the house in a restaurant. We need to reassure the food allergy community that you can take precautions to safely be accommodated while dining out. Fact has numerous resources for traveling, dining out, and information in our behavioral health center. If you're feeling anxious and on that note of feeling anxious, if you find this story or others like it really impacting you, we encourage you to seek out healthcare professionals to help you get through those tough times and to equip you with the tools that you need. Please check out our show notes for links to these important resources, or visit FAACT's website@foodallergyawareness.org dot before we say goodbye today, we just want to highlight one more time FAACT's National Gold Sponsor, the National Peanut Board, and we would like to thank them for their years of continued support and partnership. Thank you for listening to FAACT's Roundtable podcast. Stay tuned for future episodes coming soon. Please subscribe, leave a review and listen to our podcast on Pandora, Apple Podcasts, Spotify, Google Podcasts, iHeartRadio and stitch. Have a great day and always be.

Caroline: Kind to one another.