Aimmune Therapeutics, the US company developing the peanut allergy therapy dubbed ‘AR101’, is set to receive a US FDA decision regarding its marketing application for the product in September this year.
The drug is designed as a once-daily peanut allergen therapy to gradually desensitize patients from allergic reactions, symptoms, and anaphylaxis. If approved, AR101 will become the first-ever approved treatment for peanut allergy, and indeed for any food allergy.
The AR101 application was supported by data from the phase 3 PALISADE trial, in which 555 patients who reacted to ≤ 100 mg of peanut were randomized 3:1 in a double-blind, placebo-controlled food challenge. Patients were treated with either AR101 or placebo on an escalating-dose regimen. Average patient age was 11.3 years (range 4-49), and 406 (74%) had a history of peanut anaphylaxis prior to screening.
Patients received therapy over the course of 24 weeks, and those who completed the regimen participated in a double-blind, placebo-controlled food challenge to gauge progress. At the exit food challenge, 67 per cent of patients who had received AR101 were able to ingest ≥ 600 mg peanut protein without dose-limiting symptoms, compared to just 4 per cent of patients who had received placebo.
While primarily targeting peanut-allergic children and adolescents aged 4-17 years old, the developers say it’s is not a matter of the therapy not working well in older people, but more that its benefits are likely to be greater, and the daily oral dose methodology likely to be better tolerated by the younger peanut-allergic population.
For further details about this latest step in the on-going development of allergy immunotherapy drugs, see the media report at MD Magazine.