Brisbane, CA-based Aimmune Therapeutics ($AIMT) is making strides toward a peanut allergy vaccine, announcing on Monday that it enrolled the first patient in the Phase III trial of its therapeutic vaccine, AR101.
While many people with allergies carry epinephrine autoinjectors, there are no specific treatments for peanut allergy. According to Food Allergy Research and Education, approximately 3 million people report peanut and tree nut allergies in the U.S.
The Phase III trial, dubbed PALISADE, is a double-blind, placebo-controlled trial. It will be conducted at more than 60 sites in the U.S., Canada and the EU, and enroll about 500 volunteers aged four to 55 with peanut allergies. Results are expected in the second half of 2017.
|Aimmune Chief Medical Officer Robert Elfont|
"As we brought sites on for PALISADE, we heard widespread enthusiasm from allergists for the potential of an approved treatment to protect peanut-allergic patients of all ages from the effects of accidental exposure to peanuts," said Aimmune Chief Medical Officer Dr. Robert Elfont, in a statement. "We're honored to collaborate with the world's top researchers in food allergy and leading community allergists on this pivotal study. Together, they bring a wealth of experience in desensitizing allergic patients."
The trial will gauge the candidate's safety and efficacy at desensitizing peanut-allergic patients to the point that they will be protected from reactions upon accidental exposure to peanuts, Aimmune said in the statement.
Trial volunteers will be given escalating doses of the candidate for approximately 22 weeks to reach a dose of 300 mg of vaccine per day. They will continue with this dose for the following 6 months, at which point the volunteers will participate in an exit double-blind, placebo-controlled food challenge. The primary endpoint will be the toleration of a cumulative 1,043 mg of peanut protein in the food challenge. A typical peanut kernel contains approximately 250 to 300 mg of peanut protein, the company said, and upon starting the trial, volunteers should be able to tolerate only up to 44 mg of peanut protein.
The Phase II study of AR101 indicated that 78% of patients who were given escalating doses of the candidate over 22 weeks were able to tolerate a cumulative amount of 1,043 mg of peanut protein in the exit food challenge.
Meanwhile, Hershey, PA-based Immunomic Therapeutics has a peanut allergy vaccine in preclinical development and teamed up with Astellas last year to develop its therapeutic vaccine for Japanese red cedar allergies. And before the year was out, Immunomic licensed its technology to Astellas for the development of vaccines targeting other food and environmental allergies.
- here's the release