Seelos Forges Ahead With SLS-002, Says Primary Endpoint Miss Due To Underpowered Trial

The company blamed lack of funding for incomplete enrollment of the Phase II study in acute suicidal ideation and behavior in major depressive disorder, saying it would have reached statistical significance had it fully enrolled.

Seelos plans to move ahead with SLS-002's development despite a primary endpoint miss in a Phase II study • Source: Shutterstock

Seelos Therapeutics, Inc.’s Phase II study of SLS-002 (intranasal racemic ketamine) in acute suicidal ideation and behavior (ASIB) among adults with major depressive disorder (MDD) fell short of its primary endpoint because the company did not have enough funding to fully enroll it, but the company remains confident that it has sufficiently de-risked the drug.

Seelos said 20 September that data from the trial demonstrated clinically meaningful treatment effects across multiple endpoints and a well-tolerated...

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