oral immunotherapy

Antihistamines modestly reduce side effects of peanut oral immunotherapy

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The use of H1 or H2 antihistamines may mitigate some side effects of peanut oral immunotherapy, but they did not influence quality of life, according to a study published in The Journal of Allergy and Clinical Immunology: In Practice.

Future trials should explore safer approaches to food allergy treatment that improve quality of life, Derek K. Chu, MD, PhD, of the department of medicine at McMaster University in Hamilton, Ontario, Canada, and colleagues wrote.

Peanuts
Source: Adobe Stock

The randomized, three-arm, parallel-design, placebo-controlled Peanut Immunotherapy Starting in Canada, Evaluation and DiScovery, or PISCES, trial involved 43 patients (mean age, 7.8 years; age range, 5 to 11 years; 65% boys) with peanut allergy being treated with OIT at Hamilton Health Sciences’ McMaster Children’s Hospital.

Researchers assigned 10 patients to “double placebo” with placebo OIT and placebo premedication, 16 to peanut OIT with placebo premedication and 17 to peanut OIT with antihistamine premedication.

The patients assigned to antihistamine premedication before their OIT received 2.5 mg of desloratadine, a second-generation H1 antihistamine, in 5 ml by mouth once a day or 75 mg of ranitidine, an H2 blocker, in 5 ml by mouth twice a day.

The risk for experiencing at least one adverse event was higher among those treated with OIT vs. the double-placebo group, whether they received OIT with antihistamines (HR = 3.75; 95% CI, 2.79-4.72) or with placebo (HR = 4.62; 95% CI, 3.61-5.62).

However, premedication with antihistamines before peanut OIT reduced the number of moderate or severe adverse events compared with OIT without antihistamines (1.9 vs. 4.2 events per patient; incidence rate ratio [IRR] = 0.46; 95% CI, 0.24-0.89).

Still, both OIT groups saw increases in their rates of moderate or severe adverse events compared with the double-placebo group at 0.9 events each (OIT without antihistamines, IRR = 4.65; 95% CI, 2.02-10.73; OIT with antihistamines, IRR = 2.16; 95% CI, 1.01-4.6).

According to the researchers, reductions in urticaria drove these differences, with fewer events per patient on peanut OIT with antihistamines (0.6 vs. 2.1; IRR = 0.28; 95% CI, 0.1-0.8) and on double placebo (0.7 vs. 2.1; IRR = 3.04; 95% CI, 1.17-7.88) compared with patients on peanut OIT without antihistamines.

The participants on peanut OIT with antihistamines experienced numerically, but not significantly, fewer abdominal pain events than those on OIT without antihistamines (2.6 vs. 4.6; IRR = 0.61; 95% CI; 0.27-1.37), with both OIT groups experiencing more events than the 0.8 observed in the double-placebo group.

Additionally, the antihistamine premedication increased incidence of neuropsychiatric events, primarily tiredness and dizziness, compared with placebo premedication (3.35 vs. 1.06; IRR = 3.16; 95% CI, 1.84-5.42).

After 12 months, mean quality-of-life scores were 4.36 (standard deviation [SD], 1.1) for the participants on peanut OIT and antihistamines, 3.28 (SD, 0.99) for those on peanut OIT and a placebo, and 3.63 (SD, 0.62) for those in the double-placebo group, which suggested small or no differences between the groups. Reviews of specific scores pertaining to emotional impact, food anxiety and social and dietary limitations yielded similar results.

These results suggest that adverse events caused by OIT are not the only factors impacting quality of life, the researchers wrote. Also, they continued, antihistamines do not have enough of an impact on adverse events to significantly improve quality of life.

Although antihistamines do not increase the costs of oral immunotherapy, their addition to an already complex regimen should be weighed against their modest benefits and their potential for adverse effects, according to the researchers.

Future research should investigate safer food allergy treatment approaches that improve patient and family quality of life, the researchers concluded, noting that the OUtMATCH study will explore the use of omalizumab (Xolair; Genentech, Novartis) with peanut oral immunotherapy.

PERSPECTIVE

 Douglas H. Jones , MD, FAAAAI, FACAAI)

Douglas H. Jones, MD

These results are not too surprising. However, I have not used antihistamines as part of an OIT treatment protocol, as I have not wanted it to become a “crutch” or mask symptoms. Ultimately, we want patients to consume foods and doses safely without the need of other medications. I have used antihistamines in conjunction with OIT for other reasons such as environmental allergies or eczema, but they were used for that purpose and not OIT.

One interesting finding in the study was that concurrent treatment with antihistamines reduced moderate to severe but not mild OIT-induced adverse events, and yet it did not lead to important improvements in quality of life. Further, there were additional adverse effects such as sedation and dizziness in the antihistamine group.

Overall, it does not seem that adding antihistamines moved the needle much. I also think the quality-of-life assessments and conclusions were not thorough. First, there was no indication of what quality-of-life measures were accounted for. Second, they only did a baseline assessment and then another assessment 4 weeks after the desensitization. This does not allow much time for the participants to really understand the difference that OIT may have made. Third, the maximum doses achieved in this study imply that the patient would not have been allowed to free-eat foods after OIT. If this is the case, then that would likely affect quality-of-life scores. So, I think these aspects should be more carefully evaluated before drawing conclusions.

I think this study shows that OIT can be performed without antihistamines and that they are not needed as part of a protocol. Rather, they can be used to control concurrent allergic disorders such as environmental allergies or eczema.

Further research is needed into quality-of-life assessments with varying maintenance doses of OIT and after patients have been in maintenance for a longer period and incorporating foods more regularly into their diets. Also, as the article suggests, similar research with biologics may show different results as well.

Douglas H. Jones, MD

Cofounder of Global Food Therapy

Cofounder and President of Food Allergy Support Team

Director of Rocky Mountain Allergy at Tanner Clinic

Healio Allergy/Asthma Peer Perspective Board Member

Almost one-third of peanut allergies, nearly all egg allergies resolve by age 6 years

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About three out of 10 peanut allergies and nine of 10 egg allergies resolved by age 6 years, although infants with early-onset severe eczema or multiple allergies were less likely to outgrow them, according to a longitudinal study.

These findings may inform the use of disease-modifying treatments such as oral immunotherapy or proactive treatment of eczema in early life, the researchers wrote in the study, which was published in The Journal of Allergy and Clinical Immunology.

29% of children with a peanut allergy and 89% of children with a raw egg allergy at age 1 year saw their allergy resolved by age 6 years.
Data were derived from Peters RL, et al. J Allergy Clin Immunol. 2022;doi:10.1016/j.jaci.2022.04.008.

“Prioritizing research of these and future interventions for infants less likely to naturally outgrow their allergy would yield the most benefit for health care resources and research funding,” Rachel L. Peters, PhD, associate professor, epidemiologist and team lead within the population allergy research group at Murdoch Children’s Research Institute, Royal Children’s Hospital, in Parkville, Victoria, Australia, said in a press release.

Rachel L. Peters

The researchers examined data from the HealthNuts population-based longitudinal study, which tracks the prevalence and natural history of allergic diseases among 5,276 children recruited at age 1 year from council-run immunizations in Melbourne, Australia, from 2007 to 2011.

Food allergy testing was performed during the 1-year visit, with follow-up oral food challenges or new testing for patients with new symptoms conducted at 2 (egg only), 4 and 6 years along with parental questionnaires.

Although 156 children had a peanut allergy at age 1 year, these allergies resolved in 29% (95% CI, 22-38) of children with definite allergy by age 6 years.

Compared with those children whose peanut allergy had resolved by age 6 years, persistent peanut allergy appeared more common among children who had early-onset severe eczema (adjusted OR = 3.23; 95% CI, 1.17-8.88), sensitization to at least one tree nut (aOR = 2.51; 95% CI, 1-6.35) and skin prick test results of 8 mm or larger (OR = 2.35; 95% CI, 1.08-5.12) at 1 year.

Among the 471 children with raw egg allergy at age 1 year, allergies resolved in 89% (95% CI, 85-92) of those with definite allergy by age 6 years.

Additionally, compared with children whose egg allergy had resolved, persistent egg allergy was more likely among children with an SPT result of 4 mm or larger (OR = 2.98; 95% CI, 1.35-6.36), peanut or sesame food sensitizations (aOR = 2.8; 95% CI, 1.11-7.03), early-onset severe eczema (aOR = 3.77; 95% CI, 1.35-10.52) and baked egg allergy (aOR = 7.41; 95% CI, 2.16-25.3) when aged 1 year.

During the time children were aged 1 to 6 years, new-onset peanut allergies developed in 0.7% (95% CI, 0.5-1.1), and new-onset raw egg allergies developed in 0.09% (95% CI, 0.03-0.3) of the children.

At age 6 years, peanut allergy — including definite, probable and possible outcomes — had an overall weighted prevalence of 3.1% (95% CI, 2.6-3.7), and egg allergy had an overall weighted prevalence of 1.2% (95% CI, 0.9-1.6).

Additionally, SPT responses at age 1 year appeared larger among children with persistent food allergy compared with those children whose allergies had resolved, although the researchers cautioned that these test results were poor predictors of predicting peanut allergy prognoses (area under the curve, 0.64; 95% CI, 0.54-0.74) and egg allergy prognoses (area under the curve, 0.68; 95% CI, 0.58-0.78) at age 6 years.

According to the researchers, this was the first study to monitor food allergy status through standardized questionnaires, SPTs and OFCs, and its results highlight how the onset of peanut allergy after age 1 year is a real and potentially increasing problem.

Further, the researchers wrote, challenges remain in predicting which patients will outgrow their allergies and when this tolerance will occur. Such information, they continued, would help clinical management, implementation of emerging therapies such as oral immunotherapy, and family counseling.

“Prioritizing research of these and future interventions for infants less likely to naturally outgrow their allergy would yield the most benefit for health care resources and research funding,” Peters said.

Reference:

Study to assess single oral immunotherapy’s ability to treat multiple food allergens

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Oral immunotherapy has shown promise in inducing remission of specific food allergies, with one FDA-approved option available for peanut allergy, but these patients often shoulder the burden of multiple food allergies.

Alladapt Immunotherapeutics has completed patient enrollment in its Harmony phase 1/phase 2 study of ADP101, an oral immunotherapy designed for treating multiple food allergies.

The double-blind, placebo-controlled study will evaluate ADP101’s use in 73 adults and children who will be assessed at 15 sites in the United States. Nearly two-thirds of these patients have demonstrated allergy to more than one of the 15 allergens that ADP101 targets.

Healio spoke with Alladapt chief medical officer Dana McClintock, MD, and cofounder and CEO Ashley Dombkowski, PhD, to find out more about the therapy and the study.

Healio: What is the current standard of care for treating IgE-mediated food allergies?

McClintock: The standard of care across food allergy is avoidance of the food and treatment of the reactions that occur. Unfortunately, even when you’re trying your best to avoid these foods, accidental exposure occurs. That’s why patients carry an EpiPen.

The one FDA-approved therapy for treating IgE-mediated food allergies at this point is Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp, Aimmune Therapeutics), which is specific to pediatric patients who have peanut allergy. That’s the only one, unfortunately, that directly treats the disease beyond avoidance and treating reactions.

Healio: How does ADP101 aim to improve treatment?Dana McClintock

McClintock: ADP101 is a broader oral immunotherapy. Instead of being focused just on peanuts, it also will target almond, hazelnut, cashew, pistachio, pecan, walnut, milk, egg, cod, salmon, shrimp, wheat, soy and sesame. The therapy includes the ability to desensitize across the major causes of food allergy reactions — things that, unfortunately, can result in severe reactions and trips to the ED when patients have accidental exposures. It builds on that early, important work that Palforzia has done, but it’s also able to potentially help a wider range of patients who have food allergy.

Dombkowski: Whether you’re a child or an adult with an allergy, lifetime ED use is 40% to 60%. All foods have a significant risk for sending people to the ED.Ashley Dombkowski, PhD

Also, food allergy is increasingly a multi-allergic disease, as research continues to show. More than half of children with peanut allergies are multi-allergic. Two-thirds of adults with egg allergies are multi-allergic. So, with a disease that is increasingly broad in terms of potential triggers, and increasingly deep in terms of burden of disease, it really sets up the need for an approach that could be broadly applicable.

Our approach is to take oral immunotherapy and have a single, standardized, industrialized, FDA-approved, eventually reimbursed drug that is premeasured, precise and dosed for patients whether they have mono- or multi-allergy through a very broad range of triggering foods.

Food allergy is on the rise globally, yet I have rarely seen such a huge unmet medical need neglected by the biopharmaceutical industry for so long. We see food allergy as the last frontier of atopic disease. We’re excited to see pharmaceutical companies increasingly coming around to food allergy because we think patients need options and FDA-approved, validated, scientifically driven interventions that have been missing for so long.

Healio: Can you tell us about the mechanics of how a single drug can target multiple allergens?

Dombkowski: We start with raw materials that come out of the industrial food supply chain, and we put them through a manufacturing process to make them pharmaceutical-grade as per FDA. We have six tree nuts, two fin fish, a pink fish and a white fish — salmon and cod — and shrimp, soy, wheat, milk, egg, sesame, and peanut. We combine those in a very precise ratio so they are equal parts by protein weight. We also go through volume reduction to remove certain fats and in other cases carbohydrates, etc. and minimize doses. Patients can go through a two-and-a-half to three log increase in their exposure, starting at sub-milligram doses, and then increasing over time. We’re implementing a low and slow up-dosing protocol.

We spent a lot of time talking with patients, families, caregivers and clinicians about what their needs are and what they’re looking for, and we’ve incorporated that feedback. We also will continue to be on listening tours as we continue our development, and that’s included in the design of our Harmony study.

McClintock: We wanted to have the most common causes of food allergy together so we could enroll and evaluate a broad range of patients. It builds on that foundation and allows for scale for truly global products that could bring this type of therapy to a larger number of patients around the world using a very standardized and pharmaceutically approved approach.

Healio: So, the approach is designed to accommodate multiple proteins?

Dombkowski: We understand that oral immunotherapy appears to work by modulating that IgE4-to-IgE ratio. When you’re using the gut via oral immunotherapy to retrain the immune system, whether it’s a single protein or a mixture of proteins, once it goes into a patient and goes through digestion and is broken down, it’s really about the individual proteins that are taken up and seen by the immune system. So why should it just be one? A protein is a protein is a protein. Why couldn’t it be more than one, as long as you get the proteins right and make sure your dosing protocol is gentle enough? It should be able to be done simultaneously.

Healio: What can you tells us about the Harmony study?

McClintock: Patients qualify for the study based on a clinical history of food allergy that we confirm at entry using a double-blind placebo-controlled food challenge, which is the gold standard. We confirm that they are reactive to their food. Of the foods we’re looking to treat, they must react at the 100 mg level and below to at least one and no more than five. So, they are quite sensitive.

Then, they’re randomly assigned to either one of two active dose arms to achieve dose levels for maintenance or matched placebo. They go through up-dosing steps, starting very low and gradually increasing every couple of weeks until they reach a plateau level. We also have a lower dose and a higher dose plateau. We’re testing two levels, and we’ve built in flexibility to allow for patients to plateau early if needed. The goal is really to be able to help them get to that higher maintenance level over time, so we give them time to do that.

After a period of up-dosing and the maintenance level, we do an exit food challenge, where we repeat the test from the starting point. We look at how many patients can increase their threshold and how high their reactivity level is.

Many different studies have shown oral immunotherapy’s ability to raise that threshold on food challenge. That’s what we’ll be evaluating. We’re looking at our treatment vs. a matched placebo to see what percentage of patients will be able to successfully raise that threshold by the end of the study.

Healio: Was it difficult finding patients for the study?

Dombkowski: We recruited patients aged 4 to 55 years. Despite the complexities of COVID-19, we had huge demand. The demand from patients exceeded our expectations, which I think speaks to the pent-up demand and interest among this population.

Healio: What is the timetable for treatment during the study?

McClintock: Somewhere between 4 and 6 months to do the up-dosing, depending on the patient’s needs. Then another couple of months, depending on how long that first part takes to get to the exit procedure.

Healio: When do you expect to present the results?

McClintock: We’re looking at approximately a year from now because we have that up-dosing timeframe. Then we have a maintenance period of a few months. We also need to conduct those exit challenge procedures and get the data entered and analyzed.

Healio: What would the next step be after that?

Dombkowski: We’re contemplating a very robust clinical program. Obviously, we want to move ahead with phase 3 clinical development, and we’re also interested in additional ways we can think about expanded patient populations and combinations with other drugs. We really want our holistic, global, pediatric and adult population to be in our sights, and we think this program deserves to be brought to as many patients as possible.

Healio: If the study is successful, what impact will it have on patients?

Dombkowski: We are very sensitive to the feedback. We continue to see patients who are meticulous and constant in their chronic avoidance of allergens, particularly multi-allergen patients and patients who don’t have peanut allergies. Avoidance is such a burdensome endeavor. We’re committed to working with resourcing and very responsibly developing a new intervention. Our entire team goes to bed thinking about our patients, and we wake up thinking about them. We’re really all in here.

McClintock: People who don’t experience food allergies often underappreciate just how challenging it is for those who do. We’re excited to be bringing potential options to these patients who live with a lot of anxiety about what they eat, particularly when you have multiple allergies or allergies outside of peanut, which aren’t as appreciated but can be just as severe and problematic. The big focus for us is to address this unmet need, and we’re excited to be part of bringing it to the fore.

Study to assess single oral immunotherapy’s ability to treat multiple food allergens

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0


Oral immunotherapy has shown promise in inducing remission of specific food allergies, with one FDA-approved option available for peanut allergy, but these patients often shoulder the burden of multiple food allergies.

Alladapt Immunotherapeutics has completed patient enrollment in its Harmony phase 1/phase 2 study of ADP101, an oral immunotherapy designed for treating multiple food allergies.

The double-blind, placebo-controlled study will evaluate ADP101’s use in 73 adults and children who will be assessed at 15 sites in the United States. Nearly two-thirds of these patients have demonstrated allergy to more than one of the 15 allergens that ADP101 targets.

Healio spoke with Alladapt chief medical officer Dana McClintock, MD, and cofounder and CEO Ashley Dombkowski, PhD, to find out more about the therapy and the study.

Healio: What is the current standard of care for treating IgE-mediated food allergies?

McClintock: The standard of care across food allergy is avoidance of the food and treatment of the reactions that occur. Unfortunately, even when you’re trying your best to avoid these foods, accidental exposure occurs. That’s why patients carry an EpiPen.

The one FDA-approved therapy for treating IgE-mediated food allergies at this point is Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp, Aimmune Therapeutics), which is specific to pediatric patients who have peanut allergy. That’s the only one, unfortunately, that directly treats the disease beyond avoidance and treating reactions.

Healio: How does ADP101 aim to improve treatment

Dana McClintock

McClintock: ADP101 is a broader oral immunotherapy. Instead of being focused just on peanuts, it also will target almond, hazelnut, cashew, pistachio, pecan, walnut, milk, egg, cod, salmon, shrimp, wheat, soy and sesame. The therapy includes the ability to desensitize across the major causes of food allergy reactions — things that, unfortunately, can result in severe reactions and trips to the ED when patients have accidental exposures. It builds on that early, important work that Palforzia has done, but it’s also able to potentially help a wider range of patients who have food allergy.

Dombkowski: Whether you’re a child or an adult with an allergy, lifetime ED use is 40% to 60%. All foods have a significant risk for sending people to the ED.Ashley Dombkowski, PhD

Also, food allergy is increasingly a multi-allergic disease, as research continues to show. More than half of children with peanut allergies are multi-allergic. Two-thirds of adults with egg allergies are multi-allergic. So, with a disease that is increasingly broad in terms of potential triggers, and increasingly deep in terms of burden of disease, it really sets up the need for an approach that could be broadly applicable.

Our approach is to take oral immunotherapy and have a single, standardized, industrialized, FDA-approved, eventually reimbursed drug that is premeasured, precise and dosed for patients whether they have mono- or multi-allergy through a very broad range of triggering foods.

Food allergy is on the rise globally, yet I have rarely seen such a huge unmet medical need neglected by the biopharmaceutical industry for so long. We see food allergy as the last frontier of atopic disease. We’re excited to see pharmaceutical companies increasingly coming around to food allergy because we think patients need options and FDA-approved, validated, scientifically driven interventions that have been missing for so long.

Healio: Can you tell us about the mechanics of how a single drug can target multiple allergens?

Dombkowski: We start with raw materials that come out of the industrial food supply chain, and we put them through a manufacturing process to make them pharmaceutical-grade as per FDA. We have six tree nuts, two fin fish, a pink fish and a white fish — salmon and cod — and shrimp, soy, wheat, milk, egg, sesame, and peanut. We combine those in a very precise ratio so they are equal parts by protein weight. We also go through volume reduction to remove certain fats and in other cases carbohydrates, etc. and minimize doses. Patients can go through a two-and-a-half to three log increase in their exposure, starting at sub-milligram doses, and then increasing over time. We’re implementing a low and slow up-dosing protocol.

We spent a lot of time talking with patients, families, caregivers and clinicians about what their needs are and what they’re looking for, and we’ve incorporated that feedback. We also will continue to be on listening tours as we continue our development, and that’s included in the design of our Harmony study.

McClintock: We wanted to have the most common causes of food allergy together so we could enroll and evaluate a broad range of patients. It builds on that foundation and allows for scale for truly global products that could bring this type of therapy to a larger number of patients around the world using a very standardized and pharmaceutically approved approach.

Healio: So, the approach is designed to accommodate multiple proteins?

Dombkowski: We understand that oral immunotherapy appears to work by modulating that IgE4-to-IgE ratio. When you’re using the gut via oral immunotherapy to retrain the immune system, whether it’s a single protein or a mixture of proteins, once it goes into a patient and goes through digestion and is broken down, it’s really about the individual proteins that are taken up and seen by the immune system. So why should it just be one? A protein is a protein is a protein. Why couldn’t it be more than one, as long as you get the proteins right and make sure your dosing protocol is gentle enough? It should be able to be done simultaneously.

Healio: What can you tells us about the Harmony study?

McClintock: Patients qualify for the study based on a clinical history of food allergy that we confirm at entry using a double-blind placebo-controlled food challenge, which is the gold standard. We confirm that they are reactive to their food. Of the foods we’re looking to treat, they must react at the 100 mg level and below to at least one and no more than five. So, they are quite sensitive.

Then, they’re randomly assigned to either one of two active dose arms to achieve dose levels for maintenance or matched placebo. They go through up-dosing steps, starting very low and gradually increasing every couple of weeks until they reach a plateau level. We also have a lower dose and a higher dose plateau. We’re testing two levels, and we’ve built in flexibility to allow for patients to plateau early if needed. The goal is really to be able to help them get to that higher maintenance level over time, so we give them time to do that.

After a period of up-dosing and the maintenance level, we do an exit food challenge, where we repeat the test from the starting point. We look at how many patients can increase their threshold and how high their reactivity level is.

Many different studies have shown oral immunotherapy’s ability to raise that threshold on food challenge. That’s what we’ll be evaluating. We’re looking at our treatment vs. a matched placebo to see what percentage of patients will be able to successfully raise that threshold by the end of the study.

Healio: Was it difficult finding patients for the study?

Dombkowski: We recruited patients aged 4 to 55 years. Despite the complexities of COVID-19, we had huge demand. The demand from patients exceeded our expectations, which I think speaks to the pent-up demand and interest among this population.

Healio: What is the timetable for treatment during the study?

McClintock: Somewhere between 4 and 6 months to do the up-dosing, depending on the patient’s needs. Then another couple of months, depending on how long that first part takes to get to the exit procedure.

Healio: When do you expect to present the results?

McClintock: We’re looking at approximately a year from now because we have that up-dosing timeframe. Then we have a maintenance period of a few months. We also need to conduct those exit challenge procedures and get the data entered and analyzed.

Healio: What would the next step be after that?

Dombkowski: We’re contemplating a very robust clinical program. Obviously, we want to move ahead with phase 3 clinical development, and we’re also interested in additional ways we can think about expanded patient populations and combinations with other drugs. We really want our holistic, global, pediatric and adult population to be in our sights, and we think this program deserves to be brought to as many patients as possible.

Healio: If the study is successful, what impact will it have on patients?

Dombkowski: We are very sensitive to the feedback. We continue to see patients who are meticulous and constant in their chronic avoidance of allergens, particularly multi-allergen patients and patients who don’t have peanut allergies. Avoidance is such a burdensome endeavor. We’re committed to working with resourcing and very responsibly developing a new intervention. Our entire team goes to bed thinking about our patients, and we wake up thinking about them. We’re really all in here.

McClintock: People who don’t experience food allergies often underappreciate just how challenging it is for those who do. We’re excited to be bringing potential options to these patients who live with a lot of anxiety about what they eat, particularly when you have multiple allergies or allergies outside of peanut, which aren’t as appreciated but can be just as severe and problematic. The big focus for us is to address this unmet need, and we’re excited to be part of bringing it to the fore.