Investors Going Nuts For Aimmune

(RTTNews) - Shares of Aimmune Therapeutics, Inc. (AIMT) are currently trading up nearly 5 percent after the company presented a positive results for the late-stage trial of its peanut allergy treatment AR101.

The company plans to file for Food and Drug Administration approval by the end of the year, and file in Europe in the first half of 2019.

Aimmune said the pivotal Phase 3 PALISADE efficacy trial of AR101 met the primary endpoint. In the United States, AR101 has U.S. Food and Drug Administration Breakthrough Therapy Designation for peanut-allergic patients ages 4-17.

Of the 496 patients who received the treatment, 67.2% of patients who took AR101 tolerated at least 600 mg of peanut protein with no more than mild symptoms, compared to 4% of placebo patients, the company said.

Additionally, 50.3% of AR101 patients tolerated a highest dose of 1000 mg of peanut protein, compared to 2.4% of placebo patients.

The difference between response rates was 63%, and 53% at the lower bound of the 95% confidence interval, compared with a pre-specified success criterion of at least 15%, Aimmune said.

"It's great to have patients go from managing to tolerate at most the amount of peanut protein in a tenth of a peanut without reacting to successfully eating the equivalent of between two to four peanuts with nothing more than mild, transient symptoms, if any at all. Patients and their families are highly motivated to pursue an effective treatment for peanut allergy, and AR101 could give them a comfortable margin of safety in case of accidental exposures," said Wesley Burk, principal investigator for PALISADE.

AIMT is currently trading at $38.75, up $1.55 or 4.17%, on the Nasdaq.