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Drugmakers Are Planning to Start a Phase 2 Trial to Cure Peanut Allergy

Updated on
  • Collaboration to combine Aimmune’s therapy with Dupixent
  • Phase 2 clinical trial, funded by Regeneron, to start in 2018

Aimmune Therapeutics Inc. is teaming with Regeneron Pharmaceuticals Inc. in hopes of developing a cure for peanut allergies.

Aimmune, based in Brisbane, California, specializes in food allergy treatments and has been developing a desensitizing therapy, AR101, to protect peanut allergy sufferers against reactions from accidental exposures. By combining AR101 with Regeneron’s inflammation-inhibiting drug Dupixent, the companies are seeking to increase protection enough so patients stop reacting to peanuts even after treatment ends.

“What we’re learning is that the immune system does seem to be plastic, and with the right group, you can turn the disease back,” Aimmune’s chief executive officer, Stephen Dilly, said in a phone interview. “The ideal is that patients will never have to think about peanut protein again, but that’s a long way away. We have to take baby steps.”

The companies plan to start a Phase 2 clinical trial in 2018. Regeneron will fund the trial. If the results are promising, the drugmakers could explore combining Dupixent with Aimmune drug candidates for other allergies, said Dilly.

Aimmune shares were up 6.7 percent to $26.79 at 11:40 a.m. in New York on Monday. Regeneron was up 1.6 percent to $450.16.

Six Million People

About 6 million people in the U.S. and Europe have peanut allergies, including more than 2 million children, according to Aimmune. As the incidence of peanut allergies increases, more companies are becoming interested in treatments.

Swiss food giant Nestle SA’s health unit paid $145 million in 2016 for a 15 percent stake in Aimmune, a development-stage biotechnology company that doesn’t have a product on the market yet. The shares have since gained 52 percent, giving Aimmune a market value of about $1.3 billion.

Aimmune’s AR101 is a pill containing peanut protein that’s carefully regulated to ensure that it has precise amounts of the allergen. It’s currently in a final-stage trial, with results expected in early 2018. If approved on its own, patients would have to take it daily to maintain protection.

Regeneron, based in Tarrytown, New York, gained approval in March for Dupixent to treat a severe form of the skin condition eczema. Dupixent, developed in collaboration with Sanofi, dampens signaling from immune system molecules known as IL-4 and IL-13, which are thought to be key drivers of inflammatory conditions like eczema, asthma, and potentially food allergies.

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