On 3 April, Amylyx Pharmaceuticals, a clinical-stage pharmaceutical company developing a novel therapeutic for Amyotrophic Lateral Sclerosis, Alzheimer’s disease (AD) and other neurodegenerative diseases, announced that it has dosed its first participants in a recently expanded Phase II clinical trial evaluating AMX0035 in AD. The announcement has been made in collaboration with the Alzheimer’s Association, the Alzheimer’s Drug Discovery Foundation and the Cure Alzheimer’s Fund.The 24-weeks clinical trial PEGASUS is a randomised, double-blind, multi-site, and placebo-controlled Phase II study evaluating the safety, tolerability and neurobiological effects of AMX0035 in people with late mild cognitive impairment or early dementia due to AD. AMX0035 is a combination of existing compounds designed to prevent neuroinflammation and nerve cell death. Cure Alzheimer’s Fund, a non-profit dedicated to funding the most promising research to prevent, slow or reverse AD, has provided additional funding to expand the PEGASUS trial that has doubled its planned enrolment to 100 US participants from 55 to 89 years old who will receive either AMX0035 or placebo. Study results are expected in 2020.
