Avicena initiates Ph II trial of ALS drug

The Avicena Group, a USA-based developer of novel drugs and therapeutics, has initiated a Phase II clinical trial of two combination therapies incorporating ALS-08, one of its proprietary drug candidates for the treatment of amyotrophic lateral sclerosis (Lou Gehrig's disease). Investigators will assess the efficacy as well as the safety and tolerability of the creatine derivative in separate combinations with the COX-2 inhibitor celecoxib and the antibiotic minocycline in 120 patients with ALS.

According to Avicena, this six-month, multicenter, double-blind, placebo-controlled trial will randomly assign them to one of the two combination treatment arms. The study's primary endpoint is the change in the revised ALS Functional Rating Scale, while secondary outcomes include safety and tolerability, as well as additional efficacy measurements related to the ALS-08 combinations. California-based Avicena's lead compound, ALS-02, is also in development for ALS.