Avicena Group has announced that 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 (ALS or Lou Gehrig's Disease) has been initiated. Investigators will assess the efficacy, safety and tolerability of ALS-08 in separate combinations with celecoxib (a COX-2 inhibitor) and minocycline in patients with ALS.
This six-month, multicenter, double-blind controlled trial will enroll up to 120 ALS patients and 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 (ALSFRS-R). Investigators will also assess a number of secondary outcomes including safety and tolerability, as well as additional efficacy measurements related to the ALS-08 combinations.
ALS-08 is a proprietary creatine-derivative that is being developed by Avicena as a potential therapeutic for ALS.