Aimmune Therapeutics has begun its Phase 3 PALISADE trial of new peanut allergy treatment. The first patient has been enrolled in the trial and clinical tests have begun.
“With the opening of our Phase 3 PALISADE trial last month and now our first patient enrolled, we have made a significant step forward..” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D.
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) is an international, randomized 3:1, double-blind, placebo-controlled, Phase 3 trial of the efficacy and safety of lab-named AR101 as a desensitization method for peanut allergies. Aimmune’s goal is to enroll 500 peanut-allergic patients aged 4-55 years in its 60+ clinical sites in the U.S., Canada, and Europe.
Trials will take months.
The study is expected to take over a year with nine months of study per patient being involved. The goal is to prove that AR101 can bring most patients to intake levels of peanut high enough to be protected from reactions in cases of accidental exposure.
Patients will begin the study protocols with a 22-week dose escalation period to 300 mg per day and continue that maintenance point of 300 mg for about six months. At the end of that period, they will undergo an exit challenge wherein they’ll be exposed to either the allergen or a placebo in a food challenge.