By the end of January 2020, the FDA will have announced its decision regarding approval of the Aimmune Therapeutics peanut allergy drug Palforzia (AR101). The company recently presented information about their new drug, and others they have in the pipeline, at the 38th Annual J.P. Morgan Healthcare Conference.
Including Palforzia, Aimmune has three products in the pipeline. AR201 to treat egg allergies is in Phase 1 and 2 studies, while another product for multiple tree nut allergies is at the preclinical stage. The company is not obliged to conduct Phase 1 trials because the drug candidates are based on foods that don’t present toxicology issues. This factor helps to shorten the time to market timeline for Aimmune’s oral immunotherapy treatments.
Palforzia is a peanut protein powder designed to be taken daily, mixed with unheated food. This treatment must be administered by an allergy specialist, and aims to desensitize patients to peanut protein. Results from clinical trials indicate that after 12 months of receiving the treatment, people with peanut allergy can tolerate 100-fold more peanut protein without experiencing allergy symptoms. However, the tolerance decreases after the treatment ceases, indicating that regular doses must be maintained over prolonged periods.
Slides presented at the recent meeting offer more information about Aimmune Therapeutics current developments. These can be accessed by free login to the JP Morgan Healthcare Conference website.