Aimmune Therapeutics Enrolls First Patient in ARTEMIS (ARC010) European Phase 3 Clinical Trial of AR101 for the Treatment of Peanut Allergy
- Category: Vaccines
- Published on Wednesday, 05 July 2017 17:13
- Hits: 1226
- 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, CA, USA I July 5, 2017 I 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.
“Desensitization to a threshold of at least 1,000 mg of peanut protein would protect peanut-allergic patients from severe reactions following an inadvertent bite of a peanut-containing food. Achieving high levels of protection quickly and reliably is important to patients”
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 tolerating a 1,000-mg single dose of peanut protein (the equivalent of approximately three to four peanut kernels) in a progressive, exit double-blind, placebo-controlled food challenge (DBPCFC) after approximately nine months of treatment.
“Desensitization to a threshold of at least 1,000 mg of peanut protein would protect peanut-allergic patients from severe reactions following an inadvertent bite of a peanut-containing food. Achieving high levels of protection quickly and reliably is important to patients,” said Sue Barrowcliffe, General Manager of Aimmune Europe. “In a Phase 2 study of AR101 conducted in the United States, the majority of patients met the endpoint we have set for ARTEMIS, after nine months of treatment. We hope to confirm these findings with a larger patient population in ARTEMIS, which along with PALISADE will provide the key efficacy and safety data to support our potential initial marketing authorization application for AR101 in Europe.”
The enrollment criteria for ARTEMIS allow inclusion of peanut-allergic patients who react to 300 mg or less of peanut protein in an entry DBPCFC. For more information about the ARTEMIS trial, please see: https://clinicaltrials.gov/show/NCT03201003.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to achieve meaningful levels of protection by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational biologic product using CODIT™, AR101 for the treatment of peanut allergy, has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4-17 years of age and is currently being evaluated in Phase 3 clinical trials. For more information, please see www.aimmune.com.
SOURCE: Aimmune Therapeutics