4 June 2019 - - US-based biopharmaceutical company Aimmune Therapeutics, Inc. (NASDAQ: AIMT) has presented topline results from the pivotal European Phase 3 ARTEMIS clinical trial, which it previously announced had met its primary endpoint, demonstrating the efficacy and safety of AR101 in peanut-allergic children and adolescents after six months of dose escalation and a three-month therapeutic dosing phase, the company said.
The findings from the ARTEMIS trial reinforce the consistent clinical profile of AR101, demonstrating that patients tolerated 1,000 mg of peanut protein after only nine months of treatment, which was the primary endpoint of the study.
The ARTEMIS study builds on the results of the landmark PALISADE trial, which met its primary endpoint of patients tolerating 600 mg of peanut protein at 12 months. AR101 is an investigational biologic drug for use in oral immunotherapy as a treatment to reduce the frequency and severity of allergic reactions following exposure to peanuts.
These data were presented in an oral session at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2019 in Lisbon.
The proportion of AR101-treated patients who tolerated the 1,000 mg (2,043 mg cumulative) dose of peanut protein in the double-blind, placebo-controlled food challenge (DBPCFC) was significantly higher than in the placebo group: 58% vs. 2% (p