Amylyx has announced the discontinuation of Relyvrio due to the PHOENIX trial’s failure to meet primary and secondary endpoints. They will present their learnings from the trial at upcoming meetings and will publish the results of the trial in a medical journal.
Amylyx will now offer the drug for free to current patients on therapy in the U.S. and Canada, who, in consultation with their physician, decide to continue taking it.
We are extremely disappointed by this news and what it means to the ALS community. We appreciate Amylyx’s transparency and their community-centric approach to responsibly navigating the consequences of this news. We are acutely aware of the questions that this raises for the thousands of people with ALS we serve, including those currently taking Relyvrio and others who will be newly diagnosed.
ALS is a complex, heterogeneous disease. A therapy that works for one may not work for all. Results such as these are an important reminder that better tools are needed to ensure that we have the ability to better discern for whom a therapy may be promising and for whom it is ineffective. There are advancements on this front, including a wider use of genetic testing and the growing application of biomarkers. Still, there is much progress to be made.
While Relyvrio’s failure is a major setback, it also reveals key learnings that move the field forward. Every failure helps us better focus on what might actually work. Never before in the history of ALS have so many discoveries presented in such a short period of time. With dozens of potential treatments in the pipeline, scientists and researchers are urgently searching for answers to inform effective prevention strategies, treatments, and cures. Even in moments like this, there is reason for hope.
Sheri Strahl, MPH, MBA
President & CEO | ALS Network