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Amylyx Shocks With Announcement Of PHOENIX Trial Failure In ALS

 
• By Alaric DeArment

Some previously bullish analysts expressed humility as the company said the Phase III study failed to show statistical significance for Relyvrio/Albrioza on primary or secondary endpoints.

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It’s not often that companies have press events to generate excitement about an upcoming clinical trial readout, but Amylyx Pharmaceuticals, Inc. did that in February for the confirmatory Phase III PHOENIX trial of Relyvrio (sodium phenylbutyrate and taurursodiol) in amyotrophic lateral sclerosis (ALS), with scientific information about the drug, statements by executives and physicians and patient testimonials. And then a few weeks later, the study failed.

Amylyx announced on 8 March that Relyvrio, which it markets in Canada under the name Albrioza, did not achieve statistically significant results versus placebo on any of the endpoints in PHOENIX, and now the company may withdraw the drug from the market

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