After posting positive results from a midstage test of its oral immunotherapy AR101 last spring, Aimmune Therapeutics will try out its peanut allergy medication in combination with Sanofi/Regeneron’s Dupixent (dupilumab).
In March, Dupixent became the first approved drug to inhibit the IL-4 and IL-13 immune system pathways—and the first new treatment in years for atopic dermatitis, a form of eczema that can be debilitating for patients.
The Big Pharma-Biotech pair also have high hopes for the drug's potential in asthma, severe nasal allergies, and more. Today, it’s testing the waters in peanut allergy with Aimmune’s FDA Breakthrough-tagged AR101, its investigational biologic.
The three companies are planning a 2018 midstage test of AR101 with adjunctive dupilumab in peanut-allergic patients; Regeneron will sponsor the trial, with Aimmune bringing AR101 and food challenge materials to the table.
The proposed primary endpoint is set to be tolerating a certain dose of peanut protein in a double-blind, placebo-controlled food challenge that will include doses matching, and indeed exceeding, those being tested in current AR101 trials.
“We are excited to work with Regeneron and Sanofi to explore the potential of AR101 and dupilumab to increase both the degree of protection and persistence of protection against exposure to peanut protein,” said Aimmune CEO Stephen Dilly, Ph.D. “We have worked diligently with regulatory authorities and have engineered a manufacturing infrastructure that is purpose-built to meet strict cGMP and quality standards, an essential component for conducting rigorous studies such as this.”
In March 2016, AR101 helped the majority of allergy sufferers in a phase 2 trial consume peanuts safely. The trial was an extension of an earlier midstage study that tested AR101 versus placebo. Aimmune merged the two patient groups from the prior trial, gradually increasing the dosage for the former placebo arm and then giving each group daily doses of AR101 for 12 weeks.
In the end, the drug protected 100% of patients who ate 443 mg of peanuts, 90% of those who ate 1,043 mg and 60% who ate 2,043 mg. A single peanut generally measures at about 300 mg, according to the company.
And the $1.72 billion market cap biotech got a boost last November when Nestlé Health Science invested $145 million into the Brisbane, California-based company, as well as penning a two-year collaboration designed to “enable the successful development and commercialization of innovative food allergy therapies.”