Aimmune Therapeutics, Inc., has announced that its peanut allergy drug met the main goal of an eagerly awaited late-stage study, sending its shares up 18% pre-market, Reuters reports.
The positive trial data comes nearly four months after French drug developer DBV Technologies SA’s stick-on patch failed to sufficiently desensitize patients with the allergy, but the company said it would proceed to file for U.S. regulatory review.
The two companies are in a race to become the first treatment for a condition that has increased twofold in children from 1997 to 2008. The condition currently affects about 2% of American children. At present there are no approved treatments for peanut allergies, which are the leading cause of death from food-induced allergic reactions in the United States.
Aimmune said 67.2% of patients (4–17 years of age) administered AR101 tolerated at least a 600-mg dose of peanut protein in the exit food challenge, compared with 4.0% of patients on placebo. Aimmune plans to seek U.S. approval for the oral drug AR101 by the end of 2018 and approval in Europe in the first half of 2019.
The drug is sprinkled over food daily in the hope patients consuming small doses of the peanut protein will become desensitized to it over time.
“These patients are constantly walking in a minefield, a bomb could go off anytime that could end their life,” allergist Purvi Parikh, MD, of the Allergy and Asthma Network told Reuters ahead of the data. “Many are already asking for it ... and are very, very desperate for this to come out.”
Analysts widely expect the FDA to restrict use of the drug but are confident that even a tighter label is unlikely to weigh on sales given the number of patients desperate for a treatment.
Aimmune shares were trading up 18% at $43.90 pre-market. The stock had risen 85% in the past 12 months.
Source: Reuters; February 20, 2018.