Aimmune Therapeutics (NASDAQ:AIMT) has announced positive findings for its ARCoo2 clinical trial. This is a follow-on Phase 2 study of AR101 for the treatment of peanut allergy.
According to the press release:
The open-label ARC002 trial, which enrolled patients 4-21 years of age who completed the ARC001 trial earlier this year, moved former placebo patients to active treatment and followed all patients through an additional 12-week maintenance period.
In the ARC002 trial:
- The efficacy results of ARC001 were confirmed in patients who rolled over from placebo;
- No treatment-related serious adverse events occurred;
- AR101’s tolerability was supported by a low incidence of adverse events during 12 weeks of maintenance therapy; and
- A daily dose of 300 mg of AR101 for 12 weeks maintained the level of desensitization achieved from up-dosing.
“The data from our ARC002 trial bolster the positive findings of our ARC001 trial, in which all 23 patients who completed active treatment achieved desensitization to a cumulative amount of at least 443 mg of peanut protein, and 18 of those patients achieved desensitization to a cumulative amount of 1,043 mg of peanut protein, over a period of approximately 22 weeks of up-dosing,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “In food allergy studies, real-world safety comes from efficacy — every day a patient is not desensitized is a day he or she is not safe from an accidental exposure triggering a potentially life-threatening reaction. As an accidental exposure to peanut would likely involve an amount less than or equal to a whole peanut kernel, which typically contains 250-300 mg of peanut protein, both our Phase 2 trials have now demonstrated that treatment with AR101 may confer meaningful protection against accidental exposure to peanut in just 22 weeks.”
In the ARC002 trial, patients from the placebo arm of the ARC001 trial repeated the same up-dosing regimen as in ARC001, but with the knowledge that they were receiving active doses of AR101. After approximately 22 weeks of up-dosing, the patients were administered a double-blind, placebo-controlled food challenge (DBPCFC) to assess their levels of desensitization to peanut protein, with a maximum challenge dose of 600 mg (1,043 mg cumulative) of peanut protein. The efficacy, safety, tolerability and dropout rate results for these patients were consistent with those of the patients in the active treatment arm of ARC001.
Click here to read the full press release.
