Amylyx Pharmaceuticals Announces First Patients Dosed in PEGASUS Phase 2 Trial of AMX0035 in Alzheimer’s Disease and Expansion of the Trial

April 03, 2019 08:30 AM Eastern Daylight Time CAMBRIDGE, MA (BUSINESS WIRE) — Amylyx Pharmaceuticals, Inc., in collaboration with the Alzheimer’s Association, the Alzheimer’s Drug Discovery Foundation (ADDF) and the Cure Alzheimer’s Fund, today announced the dosing of its first patients in a recently expanded Phase 2 clinical trial (PEGASUS) to assess AMX0035 in individuals with Alzheimer’s [...]

Amylyx Pharmaceuticals Receives FDA Orphan Drug Designation for AMX0035 for the Treatment of Amyotrophic Lateral Sclerosis

Amylyx Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AMX0035, an oral therapeutic in clinical development for the treatment of amyotrophic lateral sclerosis (ALS). The Company recently began a Phase 2 clinical study, the CENTAUR trial, to evaluate the safety and efficacy of AMX0035 in ALS patients.

Project ALS and Amylyx Enter Collaboration to Test AMX0035

Project ALS and Amylyx Pharmaceuticals today announced a collaboration to undertake pre-clinical studies with Amylyx’s oral compound AMX0035 to advance the understanding of the compound’s neurobiological effects. The studies to be conducted at the Project ALS Pre-Clinical Core at Columbia University’s Motor Neuron Center will complement the company’s recently initiated Phase 2 clinical program of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS).