Biotech Bulletin: Progress and Setbacks in the Search for Effective Peanut Allergy Treatments
The Wait Continues for Peanut Allergy Sufferers
More than six million Americans, both adults and children, are allergic to peanuts. Peanut allergies range in severity and occur when the body’s immune system identifies even trace amounts of peanut as harmful. In the most serious cases, life-threatening anaphylaxis results from exposure to peanuts. In 2020, the FDA approved PALFORZIA, the first oral immunotherapy to help reduce the severity of allergic reactions to peanuts. The drug is designed to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is still the only FDA-approved treatment available for treating peanut allergy,
Commenting on the FDA’s decision, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said, “Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions. Even with strict avoidance, inadvertent exposures can and do occur. When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy.”
This week, Novartis ($NVS) terminated its Phase 3 clinical trial evaluating Ligelizumab in patients with peanut allergy, according to Clinicaltrials.gov, which showed that the 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study had been “terminated by sponsor”. The trial had enrolled 211 participants and had commenced in December 2021 and was listed as completed in November 2023. The company told Endpoints News that the decision was not due to any safety signals, but was based on “observations from a routine, blinded efficacy review which suggested that some patients may benefit from an improved dosing regimen”.
Novartis and Genentech’s Xolair first received FDA approval for use in children with allergic asthma in 2016 and received a subsequent approval as a treatment for moderate to severe asthma in June 2023. Xolair is under priority review for the reduction of allergic reactions to peanuts, milks, eggs and cashews in individuals as young as 1 year old. The FDA may expand the drug’s label as soon as Q1 2024.
The wait continues for peanut allergy sufferers looking for new treatments. Apart from Novartis’ contributions, Intrommune Therapeutics is investigating whether a toothpaste featuring peanut proteins could help reduce allergic reactions in children. The company dosed the last patient in a Phase I trial in June 2023 and is preparing to initiate a Phase 2 trial this year. European biotech, DBV Technologies, met the primary endpoints in its Phase 3 clinical trial evaluating its investigational drug patch, ViaSkin™ Peanut and will commence a supplemental safety trial in Q1 2024.
