(AP Photo)
Aimmune Therapeutics, Inc., a biopharmaceutical company developing treatments for potentially life-threatening food allergies, has initiated POSEIDON, an international Phase 3 clinical trial of AR101 in peanut-allergic children ages 1–3 years.
AR101 is Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy.
“We intend to submit regulatory filings for marketing approval of AR101 in the United States and Europe in 4–17-year-olds based on the positive data from the (earlier) PALISADE clinical trial, which met its primary and key secondary endpoints, as well as data from additional ongoing and completed AR101 clinical trials,” Daniel Adelman, M.D., chief medical officer of Aimmune Therapeutics.
The primary efficacy endpoint for POSEIDON is tolerating a 600-mg single dose of peanut protein (the equivalent of approximately two peanut kernels) with no more than mild symptoms in a progressive, exit, double-blind, placebo-controlled food challenge (DBPCFC) after approximately one year of treatment.
“Food allergies are a growing, potentially life-threatening condition with no approved treatments, and peanut allergy, which is often diagnosed in the first or second year of life, is one of the most common food allergies, affecting more than six million people in the United States and Europe,” said Brian Vickery, M.D., associate professor of pediatrics at Emory University and founding director of the Food Allergy Center at Children’s Healthcare of Atlanta and principal investigator for the POSEIDON trial. “This trial represents the critical next step not only in validating that early immunotherapy in young peanut-allergic children is safe and highly effective, but in generating evidence that, pending approval, AR101 can be smoothly incorporated into allergists’ practices to address the needs of children who can benefit.”
(Source: Aimmune Therapeutics, Inc.)
Filed Under: Drug Discovery
