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Aimmune's peanut allergy therapy closes in on approval with promising Phase 3 data

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Aimmune Therapeutics is gearing up for regulatory review of its investigational food allergy therapy AR101 following the release of new data which indicated that the drug met its primary endpoint, enabling allergic patients to tolerate approximately three to four peanut kernels.

According to the Phase 3 data, the proportion of patients who were able to tolerate a 1,000mg dose of peanut protein after receiving AR101 for around nine months of treatment was “significantly higher” compared to placebo.

FDA halts allergy drug approval process due to government shutdown

California-based pharma firm, Aimunne Therapeutics has been notified that due to the government shutdown, the US Food and Drug Administration (FDA) will not review the company’s Biologics License Application (BLA) for its investigational peanut allergy treatment, AR101.

As noted in the company’s financial filing published on January 14 2019, the FDA has indicated that it will not initiate the review until the government shutdown had ended, due to the fact that congress must provide funding before the FDA is able to review allergy drugs.

Aimmune's peanut allergy candidate hits main endpoint at Phase 3

US biopharmaceutical firm Aimmune has revealed that its peanut allergy candidate AR101 hit its primary endpoint in the largest trial of its kind, proving that around two-thirds of patients were are able to tolerate at least 600mg of peanut protein - equal to about two average peanut kernels – after taking the drug.

Peanut allergies? There’s a clinical trial looking to fix that

Aimmune Therapeutics, a biotech company developing treatments for food allergies, announced that it has entered into a clinical trial collaboration with Regeneron and Sanofi to develop its AR101 treatment for peanut allergies.

The clinical trial will see AR101 partnered with inflammation-suppressing therapy, Dupixent, in a Phase 2 trial. The trial will determine whether patients receiving the two therapies in combination will be able to tolerate peanut protein, as part of a double-blind, placebo-controlled food challenge.

Nestle backs allergy biotech Aimmune to the tune of $145 million

Nestle Health Science has invested $145 million in return for a 15% stake in Aimmune Therapeutics. Aimmune pursues food-allergy therapies and the move from Nestle’s subsidiary unit represents a further expansion into bioscience companies, after previous investments this year.

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