Two years after Nestlé Health Science poured $145 million into Aimmune, the company is boosting its total investment in the food allergy-focused biotech to $273 million. This brings Nestlé Health’s stake in Aimmune to 18.9% as the company prepares an FDA filing for its peanut allergy treatment.
The duo expect to close the new investment by the end of the year. It re-ups their original collaboration, inked in November 2016 and designed to “enable the successful development and commercialization of innovative food allergy therapies.”
Under the extension, as well as the original deal, Aimmune holds onto all current and future pipeline assets developed with its CODIT (characterized oral desensitization immunotherapy) approach. This includes AR101, its oral biologic “desensitization therapy” for peanut allergy, which put up strong phase 3 data in February, teeing it up for an FDA filing by the end of the year.
The phase 3 study involved 500 children who were intolerant to doses of peanut protein of 100mg or less. They were randomized to receive AR101 or placebo; after a 22-week dose escalation phase, patients continued to take AR101 or placebo until the end of the yearlong study. The investigators tested the patients’ ability to tolerate peanut protein by giving them consecutive doses of the allergen rising from 3mg to 1000mg.
More than two-thirds of patients on AR101 tolerated 600mg or more of peanut protein, compared to 4% of patients in the control group. A single peanut weighs about 300mg, with the average accidental exposure hovering around half a peanut.
“Nestlé Health Science has been a tremendous ally as we lead the way into the new field of food allergy treatment. Their expertise in the pediatric space and their insights as a premier consumer health and medical nutrition products company have advanced our thinking and will help with critical planning as we anticipate launching AR101,” said Aimmune CEO Jayson Dallas, M.D., in a statement. Dallas succeeded Stephen Dilly, who announced his retirement one year ago.
"Combined with our $255 million of cash, as of the end of the third quarter, this $98 million investment finances the company well beyond the anticipated approval and launch of AR101 in the United States. Additionally, it gives us the ability to bring AR101 to patients in Europe and to develop our pipeline of treatments for other food allergies,” Dallas said.
While AR101 is its most advanced program, Aimmune also has preclinical-stage candidates for walnut and egg allergies. Its strategy is two pronged; while its peanut program is designed to protect patients for severe reactions from accidental exposure, its egg program is aimed at reintroducing foods containing those allergens into a patient’s diet.