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Amylyx Pharmaceuticals announces top-line results from the CENTAUR Phase II clinical trial for amyotrophic lateral sclerosis

Tuesday 17 December 2019

On 17 December, Amylyx Pharmaceuticals, a pharmaceutical company developing a novel therapeutic for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases such as Alzheimer’s disease, announced top-line results from the CENTAUR Phase II clinical trial evaluating the safety and tolerability of AMX0035 for the treatment of ALS. AMX0035 is a combination therapy designed to prevent neuroinflammation and nerve cell death.

CENTAUR was designed as a randomised, double-blind and placebo-controlled Phase II study, enrolling participants between 18 and 80 years of age. Over a period of 24 weeks, participants received AMX0035 or placebo twice daily. The company reported that the study met its primary endpoint of demonstrating a significant treatment benefit for AMX0035 of slowing disease progression as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) in participants with ALS, as compared with placebo.

Detailed results will be presented at forthcoming conferences. Additionally, nearly 90% of the participants who completed the study were enrolled in an ongoing open-label extension study. Interim data are expected to be presented in 2020.