With peanuts being the most common children’s food allergen and the rising prevalence of allergies, discovering a cure for peanut allergies is crucial. Symptoms of an allergic reaction – such as anaphylaxis, leading to the inability to breathe – can be life-threatening and occur rapidly. While EpiPens are used to control general allergic reactions, there is no specific treatment available for peanut allergies – until now.
AR101 is a pill containing precise amounts of peanut flour (mainly peanut protein) that is added to food. Gradually increasing the dose over time will increase the patient’s peanut tolerance and prevent severe allergic reactions. Last week, Phase 3 clinical trial data highlighted the therapy’s success: Children who received the pill had a higher tolerance to small peanut doses than the control group, which showed no improvement. Despite the treatment’s success, there were some safety concerns: 20% of patients discontinued the trial, with 12% withdrawing due to moderate side effects. AR101 now seeks FDA approval, which would make it the first protective treatment against peanut allergies.
Viaskin Peanut is a different type of therapy – it’s an allergy vaccine administered as a skin patch containing peanut protein, which increases the patient’s tolerance to those proteins over time. In Oct 2017, Phase 3 clinical trials showed mixed results: The treatment did improve peanut tolerance in treated children compared to the control group but didn’t increase tolerance enough to meet an FDA-set statistical difference. Despite missing that mark, the unmet need for peanut allergy therapies is large enough that working in only some patients may be enough to gain FDA approval. DBV Technologies announced 2 weeks ago that it still plans to pursue FDA approval and that it has received FDA support to move forward with filing for approval.
In contrast to the other two therapies, ANB020 is not peanut allergy-specific. This drug contains a protein that inhibits a critical part of the immune response associated with various allergies. Phase 1 clinical trials showed little to no side effects and efficient immune inhibition. The data from a Phase 2a trial involving 20 adults with severe peanut allergies are expected to be released early this year.
“Though exciting advances, people should understand that these therapies are not necessarily a ‘cure’ – patients won’t be able to trash their EpiPens or stop avoiding peanut products. To maintain the protection, the patient has to take the drugs indefinitely,” comments Rose Joachim, Immunology Analyst at GlobalData.
Jenna Collier, an Immunology Ph.D. student at Harvard University, added that “these clinical trials are just the beginning – in the near future, we will likely see improvements on both safety and efficacy of treatments like these as we learn more about the complex mechanisms of peanut allergy and tolerance.”
Acknowledgements: Thank you to Rose Joachim, Immunology Analyst at GlobalData, and Jenna Collier, Immunology Ph.D. student at Harvard University, for their commentary on the implications and future of peanut allergy therapeutics.
Managing Correspondent: Chelsea Weidman
Image Credit: Photos Public Domain