Aimmune’s Late Stage Trial Win Not Enough for Investors

By Chris Lange Updated Jan 12, 3:14AM EST · Published Feb 20, 11:00AM EST

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Aimmune’s Late Stage Trial Win Not Enough for Investors — © Thinkstock

Aimmune Therapeutics Inc. (NASDAQ: AIMT) shares initially made a handy gain on Tuesday after the company reported data from its late-stage peanut allergy trial, but they quickly turned negative as the morning went on. Even though the company met its primary endpoint for its pivotal Phase 3 PALISADE efficacy trial of AR101, it was not enough for investors.

24/7 Wall St. previously mentioned Aimmune in its FDA calendar for the month of February. A few other companies are reporting data and could see a move later this month as well.

In the Aimmune study, the corresponding difference in response rates was 63.2%, and, at 53%, the lower bound of the 95% confidence interval greatly exceeded the prespecified success criterion.

Additionally, 50.3% of AR101 patients tolerated a single highest dose of 1000 mg of peanut protein, compared to 2.4% of placebo patients. In order to minimize the risk of assessment bias, the primary endpoint evaluations were conducted by independent, blinded assessors, who were not involved in patients’ ongoing care in the trial and who were blinded to treatment assignment and the sequence of the double-blind, placebo-controlled food challenge (DBPCFC).

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A. Wesley Burks, M.D., executive dean and Curnen Distinguished Professor of Pediatrics, University of North Carolina School of Medicine, and a principal investigator for PALISADE trial, commented:

It’s exciting to see this large-scale study confirm that a characterized approach to oral immunotherapy, in an appropriately supervised clinical setting, holds promise for becoming an approved treatment. 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.

Looking ahead, Aimmune expects to submit a Biologics License Application (BLA) for AR101 with the FDA by the end of 2018, followed by a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) in the first half of 2019.

Shares of Aimmune were last seen down about 5% at $35.40, with a consensus analyst price target of $57.11 and a 52-week range of $15.97 to $41.86.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.