Seelos Therapeutics announces data from Phase II study of SLS-002

Seelos Therapeutics 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, or intranasal racemic ketamine, for Acute Suicidal Ideation and Behavior, or ASIB, in adults with Major Depressive Disorder, or MDD. SLS-002 versus placebo demonstrated early and persistent reductions in symptoms of depression as assessed by the Montgomery-Asberg Depression Rating Scale, or MADRS. The graph presents results from the mixed model for repeated measures 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. MADRS results at 4 hours after dosing demonstrated a statistically significant change relative to placebo; MADRS results at 24 hours after dosing utilizing 2-way ANCOVA3 with baseline MADRS as a covariate demonstrated clinically meaningful results, but did not achieve statistical significance under the methodology used; MADRS results at 24 hours after dosing utilizing an exploratory ANOVA analysis demonstrated statistically significant change relative to placebo; MADRS results at Day 16 demonstrated a statistically significant change relative to placebo- demonstrating persistence of effect:Meaningful results further supported by: MADRS Response Rate, defined as greater than or equal to 50% reduction from baseline, at Day 16; MADRS Remission Rate, defined as a total score less than or equal to 12, at Day 16; MADRS at end of 2-week safety follow up (Day 29/30) revealed continued improvement, demonstrating no evidence of return of symptoms.