Aimmune begins patient enrolment in European Phase lll trial of AR101 for peanut allergy
US-based Aimmune Therapeutics has begun enrolling patients for the European Phase lll ARTEMIS (ARC010) clinical trial of its investigational biologic oral immunotherapy, AR101, to treat peanut allergy.
AR101 is designed for the de-sensitisation of patients with peanut allergy.
Under the AR101 trial in Europe measuring oral immunotherapy success (ARTEMIS) study, Aimmune Therapeutics will enrol around 160 peanut-allergic children and adolescents aged four to 17 at various sites in several European countries.
The randomised, double-blind, placebo-controlled trial follows Aimmune’s ongoing Phase lll PALISADE trial, which is now being carried out in eight countries within Europe, the US, and Canada.
King’s College London and Guy’s and St Thomas’ Trust paediatric allergy professor George Toit is working as an investigator in both the PALISADE and ARTEMIS trials, which are currently underway at Evelina Children's Hospital, Guy’s and St. Thomas’ NHS Foundation Trust in London.
Toit said: “We have seen great interest from peanut-allergic patients and their families in becoming participants in the Aimmune clinical trials.
“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% of children.”
The ARTEMIS trial is designed to expand the data on the level of speed to clinically meaningful modulation of the immune response to AR101 treatment.
The primary efficacy endpoint for the trial is tolerating a 1,000mg single dose of peanut protein, which is the equivalent of around three to four peanut kernels, in a progressive, exit double-blind, placebo-controlled food challenge (DBPCFC) after nearly nine months of treatment.
According to Aimmune Therapeutics, the enrolment criteria for ARTEMIS allows the addition of peanut-allergic patients who react to 300mg or less of peanut protein in an entry stage DBPCFC.