Seelos Reports Mixed Results From Phase II Ketamine Study

Seelos Therapeutics, Inc. (Nasdaq: SEEL) 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).

However, while Montgomery-Åsberg Depression Rating Scale (MADRS) results at 24 hours after dosing utilizing 2-way ANCOVA with baseline MADRS as a covariate (the pre-defined primary endpoint/analysis) demonstrated clinically meaningful results, it did not achieve statistical significance under the methodology used (p=0.069, 3.3 point LS mean treatment difference).

“The analyses of the 147 enrolled subjects in this multicenter, double-blind placebo-controlled trial of SLS-002 demonstrated both meaningful early and persistent improvement in depressive symptoms, as well as clinically meaningful reduction in acute suicidality symptoms relative to standard of care,” said Tim Whitaker, M.D., Chief Medical Officer of Seelos. “We believe these results demonstrate the therapeutic potential of SLS-002 to address this huge unmet need and those at risk. We look forward to our discussions with the FDA to align on next steps. In addition, we want to thank the study participants, as well as the clinical trial sites and staff, for their expert and careful care of these high-risk study patients.”

Seelos said in a statement that the SLS-002 drug 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.

Smaller Study Size

The company had planned on enrolling 220 patients, however, due to financial constraints, only 147 patients diagnosed with MDD requiring psychiatric hospitalization due to significant risk of suicide were randomized. Seelos did note that due to the limited sample size, the study did not meet the pre-defined primary endpoint (MADRS ANCOVA at 24 hours post-dosing). “However, assuming the same treatment difference and standard deviation, analyses showed that the study would have achieved statistical significance for the primary endpoint, had the study reached full enrollment (220 patients).”

“The analyses of the 147 enrolled subjects in this multicenter, double-blind placebo-controlled trial of SLS-002 demonstrated both meaningful early and persistent improvement in depressive symptoms, as well as clinically meaningful reduction in acute suicidality symptoms relative to standard of care,” said Tim Whitaker, M.D., Chief Medical Officer of Seelos. “We believe these results demonstrate the therapeutic potential of SLS-002 to address this huge unmet need and those at risk. We look forward to our discussions with the FDA to align on next steps.”

“We believe these data are remarkable. We expect to move forward with our development of SLS-002 after the end of Phase II meeting with the FDA,” said Raj Mehra Ph.D., Chairman and Chief Executive Officer of Seelos. “The improvements with SLS-002 were robust and continued to improve across efficacy scales with 5 doses over the two-week treatment period. In addition to the data on efficacy, the differentiated and well-tolerated safety profile of SLS-002 highly underscores this product candidate’s uniqueness and potential for the treatment of ASIB in MDD. We look forward to advancing this therapy toward a potential first approval for an important unmet need for this patient population, especially considering that 2022 experienced the highest number of suicides in U.S. history.”

The post Seelos Reports Mixed Results From Phase II Ketamine Study appeared first on Green Market Report.

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