Brisbane, CA, biotech Aimmune Therapeutics ($AIMT) said its in-development treatment for peanut allergies performed well in an open-label study, burnishing the company's hopes for success in a recently launched Phase III trial.
Aimmune's oral immunotherapy, AR101, helped a majority of allergy sufferers consume peanuts safely, the company said. The trial was an extension of an earlier Phase II study that tested AR101 versus placebo. Aimmune merged the two patient groups from the prior trial, gradually increasing 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, Aimmune said. A single peanut generally measures at about 300 mg, according to the company.
Patients experienced roughly one adverse event per month in the up-dosing period of the trial, Aimmune said, a rate that dropped to once every two to three months during daily administration. There were no serious side effects in the trial, according to the company, but 5 patients dropped out due to gastrointestinal issues that cleared up within two weeks of cessation.
Aimmune sees the open-label results as confirmation of AR101's promise as the company works through late-stage development. In January, Aimmune began enrollment on a 500-patient Phase III trial with a primary endpoint of helping patients tolerate at least 1,043 mg of peanuts over 12 months. The company expects to report results in the second half of 2017.
AR101 picked up the FDA's coveted breakthrough therapy designation last year, granting Aimmune preferred access to agency officials and giving the company a shot at early approval. The drug's potential helped Aimmune raise $160 million in an IPO in August, and the company's shares have risen about 10% since.
Aimmune, formerly Allergen Research Corporation, is at work on a pipeline of what it calls characterized oral desensitization immunotherapies, or CODITs. Unlike post-reaction treatments like epinephrine, CODITs work by gradually diminishing the body's response and eventually rendering patients desensitized to clinically meaningful levels of food allergens. The biotech has also disclosed early-stage projects in egg and milk allergies.
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