An experimental allergy treatment is advancing down the clinical development pipeline.
Aimmune Therapeutics announced it will work with Sanofi and Regeneron to test its investigational biologic oral immunotherapy labeled AR101 in conjunction with the other company’s monoclonal antibody called Dupilent in a Phase II clinical trial.
Investigators will explore the combination therapy’s desensitization capabilities against placebo on peanut-allergic patients.
The proposed primary endpoint will be seeing how participants tolerate a certain dose of peanut protein in a double-blind, placebo-controlled food challenge. This would include doses matching and exceeding those being tested in current studies with AR101 not related to this collaboration.
Another component of this investigation will involve a proposed exploration of, “sustained unresponsiveness,” after discontinuation of therapy in another food challenge, according to the announcement.
Sustained unresponsiveness occurs when patients allergic to peanuts are able to tolerate a defined amount of peanut protein with no more than mild allergic symptoms, especially after a break in treatment.
“The incidence of food allergy continues to rise and with it the risk of life-threatening allergic reactions,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron, in a statement. “Dupilumab targets the IL-4/IL-13 signaling pathway, which is a critical driver of allergic inflammation. In particular, both preclinical and clinical studies suggest that dupilumab can be a major regulator of the IgE-IgG4 axis. We look forward to collaborating with Aimmune to evaluate if adjunctive treatment with AR101 and dupilumab can help further protect people with peanut allergies.”
This trial is expected to begin in 2018. Regeneron will be its sponsor while Aimmune will provide the clinical supply of AR101 and food challenge materials.
Currently, there are no approved treatments for peanut allergies.
Filed Under: Drug Discovery