Amylyx Pharmaceuticals

AMX0035 is an experimental therapy, an oral coformulation of 2 active compounds, sodium phenylbutyrate and taurursodiol. Key production steps ensure these 2 compounds are combined correctly to maintain powder shape, ensure proper absorption and meet rigorous quality control standards; Outside of the AMX0035 coformulation, there is no information to support the combination of these 2 molecules in such a way as to maintain patient safety and product quality.

AMX0035 aims to reduce neuronal death by simultaneously mitigating endoplasmic reticulum stress and mitochondrial dysfunction.

Amylyx is currently exploring the potential of AMX0035 as a treatment option for amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Wolfram syndrome.

The company has completed a Phase 2 clinical trial in the United States of America and at the end of 2021 has launched a Phase 3 clinical trial in both the United States of America and Europe.

Furthermore, in January 2022, the company announced that it had applied for the marketing authorization of its product to the European Medicines Agency after having also applied to the Canadian and US regulatory agency.