08:50 AM EST, 03/08/2024 (MT Newswires) -- Amylyx Pharmaceuticals ( AMLX ) said Friday that its phase 3 clinical trial evaluating AMX0035 in patients with amyotrophic lateral sclerosis, or ALS, failed to meet the primary and secondary endpoints at week 48.

The company said it has decided to halt the promotion of the drug, Relyvrio in the US and Albrioza in Canada, and may decide within the next eight weeks to voluntarily withdraw this from the market. People living with ALS will continue to receive Relyvrio and Albrioza as well as support services at this time, Amylyx added.

The phase 3 Phoenix trial, which enrolled 664 people living with ALS, showed there was "no significant" difference observed between patients receiving AMX0035 and placebo in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale total score change from baseline at week 48, although the drug showed a consistent safety profile, according to the company.

Amylyx said it will continue studies evaluating AMX0035 in Wolfram syndrome and progressive supranuclear palsy.

Shares of the company fell almost 81% in recent Friday premarket activity.

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