Amylyx’s ALS Treatment Relyvrio Disappoints in Phase III PHOENIX Study, Company Considering Market Withdrawal

1. Amylyx Pharmaceuticals' ALS treatment Relyvrio (also known as AMX0035) has failed a crucial Phase III clinical trial, the PHOENIX study, which involved 664 patients with ALS.
2. Relyvrio did not outperform a placebo on the ALS functional rating scale, and all secondary outcomes, including quality-of-life questionnaires, disease spread, and muscle function, were not statistically significant.
3. The p-value on the trial's main goal was 0.667, indicating no benefit provided by Relyvrio.
4. Amylyx is considering voluntarily withdrawing Relyvrio from the market and will announce its plans within eight weeks, engaging with regulatory authorities and the ALS community to discuss the results.
5. Relyvrio was previously approved by the FDA based on the CENTAUR study, which showed a small but significant effect on survival and function; however, the PHOENIX study did not meet the primary or secondary endpoints.
6. Amylyx has paused the promotion of Relyvrio during this time, and the drug will continue to be available for people living with ALS, with related patient support services remaining in place.