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Welcome to our December research update! Getting involved with research is an important way to impact food allergy treatments, education, and awareness.

Our community members have had several questions about a recent study that showed a link between IgE-mediated food allergy and heart disease. In our summary below under “Latest Food Allergy News,” we explain the study, debunk misinformation about the results and explain there are no immediate concerns for people with food allergy.

This month, we are also highlighting research opportunities and news on:

  • A clinical trial for children with peanut allergy
  • A research opportunity to share your thoughts on the effects of sesame labeling
  • Eosinophilic esophagitis (EoE)
  • Multi-food oral immunotherapy
  • Under-the-tongue epinephrine


Clinical Trials

Now Enrolling: The VITESSE Phase 3 Study for Peanut Allergy

Boy sitting on a park bench next to a cartoon dinosaur

The VITESSE phase 3 clinical research study is looking for children 4 to 7 years of age who have been diagnosed with peanut allergy and are currently following a strict peanut-free diet. Study doctors are testing an investigational drug patch (also called study drug patch) to learn how well it works and how safe it is in children with peanut allergy.

  • What should I know about the VITESSE study?
    • To be eligible for this study, participants must be*:
    • 4 to 7 years of age
    • Diagnosed with peanut allergy
    • Currently following a strict peanut-free diet

*Other inclusion/exclusion criteria will apply.

  • This study will consist of at least 12 study visits and 5 phone calls over a period of approximately 58 weeks (about 1 year)
  • Participants will be randomly assigned (by chance) to receive the study drug patch or placebo patch (looks like the study drug but contains no active drug). Participants will have about a 67% (2 in 3) chance of receiving the study drug patch and about a 33% (1 in 3) chance of receiving the placebo patch
  • The health and safety of participants will be monitored throughout the study
  • Participant data and information will be kept confidential according to applicable laws for clinical research studies
  • Study participants will receive all study-related procedures and the study drug patch or placebo patch at no cost

To learn more about the VITESSE phase 3 study and eligibility criteria, please visit VitesseAllergyStudy.com or ClinicalTrials.gov (identifier: NCT05741476).

Study sponsored by DBV Technologies



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Interviews and Focus Groups

Share Your Thoughts on the Effects of Sesame Labeling

If you or someone you provide care for has a sesame allergy, we would like to ask you about recent sesame allergen labeling legislation. A project at the University of South Carolina is compiling stories to describe the impact of the FASTER Act on people managing sesame allergies.

Contact Richie Holmberg at the University of South Carolina for more information and to participate in this study: holmberr@email.sc.edu.

LEARN MORE



Latest Food Allergy News

Food Allergy        

Study Finds Association Between IgE to Common Food Allergens and Heart Disease: Here’s What You Need to Know
A recent study found that IgE to common food allergens is associated with heart disease. Misinformation about the findings of the study are being shared widely, so here are some key things you need to know:

  • The study looks at sensitization, which is the presence of an allergic antibody. While sensitization is a prerequisite for food allergy, it is not the same thing as having a food allergy.
  • The study looks at the association between the two factors, meaning changes in one factor can sometimes lead to changes in the other. The results do not show that IgE to common food allergens leads to heart disease.
  • The study did not look at whether people had allergic reactions or were avoiding the foods they were sensitive to. This information could provide important context to the results.
  • There is still a lot that is unknown about why this connection. Other factors that were not included in the study may play a role. More research is needed to understand the association.

While the study highlights a previously unknown association, the results should not cause any immediate concern for the food allergy community. People with food allergies or known IgE levels should not change their food allergy management without talking to a doctor first.

Alladapt’s Allergy Treatment Receives FDA Fast Track Designation
Alladapt Immunotherapeutics has received Fast Track Designation from the Food and Drug Administration (FDA) for its ADP101 product. APD101 is an investigational multi-food oral immunotherapy (mOIT). This kind of treatment helps the body gradually tolerate a food allergen by slowly raising the amount of food allergens someone can eat before it triggers an allergic reaction. The product aims to address multiple food allergies and single food allergies in children ages 4 to 17 years with confirmed allergies to specified foods. The designation is supported by clinical research that showed promising results in its ability to desensitize patients to their allergens. Fast Track Designation can speed up the review process for potential treatments, potentially benefiting people with food allergies sooner.



Anaphylaxis

Aquestive Therapeutics Doses First Patient in Phase 3 Pivotal Clinical Study Evaluating Pharmacokinetics and Pharmacodynamics of Anaphylm™ (Epinephrine) Sublingual Film
Aquestive Therapeutics has started a crucial study for its product Anaphylm™. Anaphylm is an under-the-tongue epinephrine product used for severe allergic reactions. The study will compare the performance of Anaphylm to other forms of epinephrine. The goal of the study is to understand how the body absorbs and reacts to the medicine. The company aims to file Anaphylm for FDA approval in 2024, emphasizing its potential as a convenient and effective needle-free treatment for severe allergic reactions.



EoE

EsoCap Reports Positive Topline Results from ACESO Phase II Trial Investigating ESO-101 in Eosinophilic Esophagitis
EsoCap AG, a Swiss biotech company, recently announced positive results on their clinical trial looking at ESO-101. ESO-101 is a potential treatment for eosinophilic esophagitis (EoE). It’s a capsule with a thin, rolled-up film containing an anti-inflammatory corticosteroid. The ACESO Phase II trial included 43 adult patients across five European countries. The study found that ESO-101 significantly reduced the peak eosinophil count in esophageal biopsies compared to a placebo, meeting the primary endpoint. Additionally, ESO-101 was found to be safe and well-tolerated, with a unique delivery system that makes it easy for patients to swallow. The detailed results, including secondary endpoint data, will be presented at a future scientific conference.



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