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Aimmune Therapeutics Enrolls First Patient in ARTEMIS (ARC010) European Phase 3 Clinical Trial of AR101 for the Treatment of Peanut Allergy

— Trial Will Augment Ongoing Phase 3 PALISADE Trial and Explore Endpoint of Tolerating at Least 1000-mg Dose of Peanut Protein to Support AR101 Regulatory Filings in Europe —

BRISBANE, Calif.--(BUSINESS WIRE)-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), today announced the enrollment of its first patient in the European Phase 3 ARTEMIS (ARC010) clinical trial of AR101 for treatment of peanut allergy. AR101 is Aimmune's investigational biologic oral immunotherapy for desensitization of patients with peanut allergy.

The randomized, double-blind, placebo-controlled ARTEMIS (AR101 Trial in Europe Measuring oral Immunotherapy Success) clinical trial of AR101 will enroll approximately 160 peanut-allergic children and adolescents ages 4-17 at multiple sites in several European countries. The ARTEMIS trial follows Aimmune's ongoing Phase 3 PALISADE trial, taking place in eight countries in Europe, the United States, and Canada.

"We have seen great interest from peanut-allergic patients and their families in becoming participants in the Aimmune clinical trials," said Prof. George du Toit, M.B., B.Ch., Professor of Paediatric Allergy at King's College London, Guy's and St Thomas' Trust. "Participants and their families are keen to potentially benefit from an investigational treatment in a disease area where there are currently no approved products, and are motivated to contribute to developing our understanding of peanut allergy and its treatment. We are all excited by the momentum in the field and the potential impact a new treatment could have on the burden of peanut allergy, which in many countries affects up to 2 percent of children." Professor du Toit is an investigator for the PALISADE and ARTEMIS trials, currently underway at the Evelina Children's Hospital, Guy's and St. Thomas' NHS Foundation Trust in London.

Aimmune designed the ARTEMIS trial to expand the data on the level of and speed to clinically meaningful modulation of the immune response to AR101 treatment. The primary efficacy endpoint for ARTEMIS is...


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