Seelos Therapeutics, Inc. (NASDAQ: SEEL) shares careen sharply lower Wednesday. The firm, a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced top line data demonstrating clinically meaningful treatment effects across multiple endpoints and a well-tolerated safety profile from the double-blind, placebo-controlled cohort (Part 2) of its Phase II study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in adults with Major Depressive Disorder (MDD).
SLS-002 versus placebo demonstrated early and persistent reductions in symptoms of depression as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). The graph presents results from the mixed model for repeated measures (MMRM) analysis of change from baseline in MADRS total score.
Target enrollment of this study was 220 patients, however, due to financial constraints, only 147 patients diagnosed with MDD requiring psychiatric hospitalization due to significant risk of suicide were randomized. The data from the 147 subjects (67% of target enrollment) were evaluated using the protocol-defined methods of analysis. Due to the limited sample size, the study did not meet the pre-defined primary endpoint (MADRS ANCOVA at 24 hours post dosing)
SEEL shares tumbled 71 cents, or 70.8% to 29 cents.
