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

The Asthma and Allergy Foundation of America (AAFA) and its food allergy division Kids with Food Allergies (KFA) work with doctors, researchers, patients, caregivers, public health, and government agencies to conduct and support research that is important to people affected by asthma and allergies.

Here are current research opportunities you can get involved in as a person with asthma or allergies (or as a caregiver for someone with asthma and allergies):

Latest News on Food Allergies, Asthma, and Other Allergic Conditions

New Report on the Current State of Health Care for Eosinophilic Esophagitis
AAFA and the American Partnership for Eosinophilic Disorders (APFED) published a new report called “Life with EoE: The Patient Experience and Opportunities to Improve Care in the U.S.”

The report highlights the current state of EoE care in the United States. This includes challenges and barriers to timely diagnosis, quality medical care, effective treatments, and access to resources for EoE. These challenges also present opportunities to address the unmet needs and improve future care for people living with EoE in the United States.

This report is the result of a research study on the needs of people with EoE and their caregivers. We collected data through social listening of peer-to-peer discussions, one-on-one interviews with people with EoE and caregivers, a survey of people with EoE and caregivers, and a survey of health care providers who treat people with EoE.

Under-the-Tongue Epinephrine Film, Anaphylm™, Showed Positive Results in Recent Clinical Tests
Aquestive Therapeutics, a pharmaceutical company, conducted pilot studies to test their new product called Anaphylm. Anaphylm is an under-the-tongue epinephrine being developed to treat severe allergic reactions. The pilot studies focused on the effectiveness and safety of Anaphylm.

The results showed that Anaphylm was able to deliver epinephrine within 10 minutes of being given. These results are positive as severe allergic reactions, called anaphylaxis, need to be treated quickly. The studies also compared Anaphylm with auto-injector forms of epinephrine. The data showed that Anaphylm provided higher epinephrine levels during the first 10 minutes compared to the other forms. The studies found no major adverse events reported among the participants who received Anaphylm. This suggests the treatment is safe and well-tolerated by patients. Aquestive Therapeutics plans to submit a protocol for another trial to the Food and Drug Administration (FDA) later this year. This trial will provide further information on the effectiveness and safety of Anaphylm.

FDA Advisory Committee Unanimously Recommends Nirsevimab as the First Vaccine Against RSV for All Infants
The FDA Antimicrobial Drugs Advisory Committee (AMDAC) has voted in favor of a new vaccine to help prevent respiratory syncytial virus (RSV) in newborns and infants. The vaccine is called nirsevimab. The committee unanimously agreed that nirsevimab is effective in preventing RSV lower respiratory tract disease (LRTD) in newborns and infants during their first RSV season and for children up to 24 months old who are still at risk in their second RSV season.

If approved, nirsevimab would be the first vaccine designed to protect all infants during their first RSV season, regardless of their health condition or preterm status. The FDA accepted the application for nirsevimab in 2022 and is expediting its review. The FDA will consider the AMDAC’S recommendation during its review of the application for nirsevimab. If approved by the third quarter of 2023, nirsevimab will be available in the U.S. before the 2023-2024 RSV season.

FDA Announces Additional Steps to Modernize Clinical Trials
The FDA has released draft guidance with updated recommendations for good clinical practices (GCPs) in clinical trials. The goal is to modernize the design and conduct of trials, making them more efficient without compromising the safety of participants or the accuracy of the data collected.

GCPs are important for participant safety and data integrity. But the current trial system has been seen as costly, inefficient, and lacking collaboration and innovation. The new draft recommendations aim to streamline trials, making them more flexible and efficient.

The FDA hopes that the finalized recommendations will encourage thoughtful and safe approaches to clinical trials while embracing innovative technologies and trial designs, such as the use of digital health technologies like wearable sensors to facilitate data collection and patient recruitment. The draft guidance will be open for public comment for 60 days. They will consider feedback before finalizing the guideline.