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Amylyx founders — Justin Klee (left) and Joshua Cohen are the co-founders and co-CEOs of Amylyx Pharmaceuticals. Kayana Szymczak for STAT

Amylyx Pharmaceuticals said Friday that its treatment for ALS, called Relyvrio, failed to provide any benefit for patients in a large clinical trial — a stunning outcome that now has the company considering a voluntary withdrawal of the approved medicine from the market.

“This is really hard for us, and it’s really hard for our team who care so much, but it’s so much harder for people with ALS and their families, and we have to keep that perspective,” said a somber Justin Klee, Amylyx’s co-founder and co-CEO, in an interview with STAT on Thursday evening.

In the Phase 3 study involving 664 people with ALS, Relyvrio failed to outperform a placebo on an ALS functional rating scale that measures the ability to perform daily living tasks, walk, breathe, speak, and swallow. The company did not provide detailed results for the study’s primary goal, but said the calculation for statistical significance was 0.67 — well above the 0.05 threshold for success and an indication that Relyvrio provided no benefit at all.

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