20.09.2023 14:31:23

Seelos Therapeutics: SLS-002 Phase II Study Fails To Meet Primary Endpoint On Limited Sample Size

(RTTNews) - Seelos Therapeutics, Inc. (SEEL) reported top line data showing clinically meaningful treatment effects across multiple endpoints and a well-tolerated safety profile from the double-blind, placebo-controlled cohort of its Phase II study of SLS-002 for Acute Suicidal Ideation and Behavior in adults with Major Depressive Disorder. The company said target enrollment of the study was 220 patients, however, due to financial constraints, only 147 patients were randomized. Due to the limited sample size, the study did not meet the pre-defined primary endpoint.

"We expect to move forward with our development of SLS-002 after the end of Phase II meeting with the FDA," said Raj Mehra, CEO of Seelos.

Shares of Seelos Therapeutics are down 65% in pre-market trade on Wednesday.

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