Disappointing Results in Latest ALS PHOENIX Trial

Amylyx recently announced the results from the PHOENIX trial, a global 48-week Phase 3 clinical trial of their drug AMX0035 (also known as RELYVRIO® in the U.S. and ALBRIOZA™ in Canada) for treating amyotrophic lateral sclerosis (ALS).

The trial involved 664 people with ALS, who were randomly assigned to receive either AMX0035 or a placebo. Unfortunately, the trial did not meet its primary goal of showing a significant improvement in the ALS Functional Rating Scale score after 48 weeks. Secondary goals also did not show significant results.

Despite these disappointing results, Amylyx remains committed to the ALS community. They plan to present the trial data at a medical meeting and publish it in a medical journal later this year. They will also continue discussions with regulatory authorities, ALS specialists, patients, and advocates to decide on the next steps, which might include withdrawing RELYVRIO/ALBRIOZA from the market. For now, the drug and its support program will still be available, although Amylyx has paused its promotion.

Justin Klee and Joshua Cohen, the Co-CEOs of Amylyx, expressed their surprise and disappointment with the results, especially after positive data from a previous trial, CENTAUR. They emphasized their commitment to keeping the ALS community informed and making decisions based on what is best for patients and what the science supports. They thanked the trial participants and study teams, highlighting that the data collected will be valuable for future ALS research.

The trial showed that AMX0035 was well-tolerated, with no new safety concerns. 
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