Amylyx begins Phase II of AMX0035 for ALS

Amylyx Pharmaceutical Corp. (Cambridge, Mass.) began the Phase II CENTAUR trial to evaluate twice-daily oral AMX0035 for 24 weeks in 132 patients with amyotrophic lateral sclerosis (ALS).

The double-blind, placebo-controlled, U.S. trial will evaluate the primary endpoints of safety and the change from baseline over 24 weeks in ALS Functional Rating Scale-Revised (ALSFRS-R). Secondary endpoints include change in Accurate Testing of Limb Isometric Strength (ATLIS), blood and imaging biomarkers, slow vital capacity (SVC) and rates of survival, tracheostomy and hospitalization...