Aimmune reveals data from its ARC002 Phase 2 trial

Aimmune Therapeutics Inc. recently revealed data from the open-label ARC002 Phase 2 trial for its product, AR101, designed to treat peanut allergies.

Every patient that took part in the trial, which lasted 12 weeks, received a low-dose maintenance therapy and showed resistance to the peanut protein, normally found in one peanut kernel.

During the ARC002 trial, 40 patients participated in a post-up-dosing maintenance therapy of 12 weeks. Each patient was given 300 mg of AR101 in a double-blind, placebo-controlled door challenge (DBPCFC) during that span.

Patients were able to tolerate at rate of 100 percent, 90 percent and 60 percent increasing cumulative amounts of peanut protein of 443 mg, 1,043 mg, and 2,043 mg, respectively. The patients who achieved the highest level of resistance were protected from seven to eight peanuts.

The ARC002 trial is a follow-up to Aimmune’s ARC001 Phase 2 trial. In the ARC002 trial, the 26 patients who were given placebos during the first trial were switched over to AR101. During the 22 week trial, 21 out of 26 reached a daily dose of 300 mg before participating in the DBPCFC.