Relyvrio/AMX0035 Phase 3 Clinical Trial Results Announced

Mark HeidenAdvocacy, Foundation Blog, Home Page

UPDATE: Amylyx Pharmaceuticals has announced that Relyvrio will be removed from the market, and that patients on the therapy as of April 4 in the U.S. and Canada who, in consultation with their physician, wish to continue can be transitioned to a free drug program.​ See their patient support page for details.

Amylyx Pharmaceuticals has announced that Relyvrio was not successful in its Phase 3 large global clinical trial. Like many in the ALS community, we are deeply saddened by this news. The trial data found that Relyvrio did not work better than a placebo, although it was generally well-tolerated by those who took it. Amylyx is considering withdrawing Relyvrio, also known as AMX0035, from the market.  

We understand that this is incredibly hard news to hear for the ALS community. We expect to learn more in the coming weeks. If you are currently taking Relyvrio, please do not stop without consulting your physician or research study team.   

What’s worth celebrating is that a treatment for ALS did receive a Phase 3 clinical trial. That has been all too rare for ALS. For a treatment to reach this point, there had to be scientific research, funding, regulatory support, and most importantly, a dedicated community of clinicians and clinical trial participants behind it. We’re proud to have been part of those trials, and grateful to those who made it possible. 

To bring an end to this disease, we need more ALS treatments to reach this stage. We need the same commitment, from research to industry to government, to seeing promising opportunities through. Not every treatment will succeed. But one day, one will.