Seelos: Phase 2/3 HEALEY ALS Trial Fails To Meet Statistical Significance In Endpoints

(RTTNews) - Seelos Therapeutics, Inc. (SEEL) issued an update on top-line data of the Phase 2/3 HEALEY ALS Platform trial. The study was designed to evaluate SLS-005 in decreasing the slope of the ALS Functional Rating Scale and separation from placebo in Function and Mortality in an all-comers population of Persons with Amyotrophic Lateral Sclerosis. The company said, while the study did not meet statistical significance in the primary and secondary endpoint in the Full Analysis Set, by showing a 13% improvement in Function and Mortality with an 88% success probability, it showed a potential signal of efficacy in a pre-specified subgroup.

Raj Mehra, Chairman and Chief Executive Officer of Seelos, said: "We plan to request a meeting with the FDA to discuss potential next steps for the program and will continue our potential partner discussions."

Shares of Seelos Therapeutics are down 48% in pre-market trade on Tuesday.

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