Detailed PHOENIX Study Reveals Relyvrio’s Failure in ALS Treatment

1. The PHOENIX study, a global, 48-week, randomized, placebo-controlled Phase 3 clinical trial, evaluated AMX0035 (also known as Relyvrio in the U.S. and ALBRIOZA in Canada) in patients with ALS.
2. The PHOENIX study did not meet its primary endpoint of reaching statistical significance (p=0.667) as measured by change from baseline, nor were there statistically significant results seen in secondary endpoints.
3. Amylyx Pharmaceuticals, Inc. announced the topline results from the PHOENIX study, which included 664 patients with clinically definite or clinically probable ALS within two years of symptom onset.
4. Amylyx plans to present the PHOENIX data at an upcoming medical meeting and publish the results in a medical journal.
5. The company will engage with regulatory authorities and the ALS community to discuss the PHOENIX results within the next eight weeks and may consider voluntarily withdrawing Relyvrio/ALBRIOZA from the market.
6. Relyvrio/ALBRIOZA and its related patient support program will continue to be available for people living with ALS at this time.
7. The PHOENIX study reinforces that AMX0035 is generally safe and well-tolerated, with common adverse reactions including diarrhea, abdominal pain, nausea, and upper respiratory tract infection.

These findings suggest that Relyvrio did not demonstrate efficacy in the PHOENIX study, which may lead to significant changes in the availability and marketing of the drug for ALS treatment.