Positive results announced in phase 2 trial of intranasal ketamine for adults with MDD
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Key takeaways:
- Data from the phase 2 study showed early and persistent reduction in symptoms of depression.
- Treatment with SLS-002 resulted in clinically meaningful reduction in acute suicidality.
A Manhattan-based biopharmaceutical firm has announced positive topline data from its phase 2 trial of a novel formulation of intranasal racemic ketamine for acute suicidal ideation and behavior in adults with major depressive disorder.
According to Seelos Therapeutics, the double-blind, placebo-controlled cohort of its ongoing study of SLS-002 compared with placebo demonstrated early and persistent reductions in symptoms of depression for its 147 participants, as assessed by the Montgomery Åsberg Depression Rating Scale (MADRS).
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The company acknowledged the study did not meet the pre-defined primary endpoint (MADRS ANCOVA at 24 hours post-dosing), but said in a release that treatment with the novel therapeutic resulted in “clinically meaningful” reduction in acute suicidality as measured by both the Sheehan-Suicidality Tracking Scale (S-STS) total score and the Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-S/IB), at both 4-hour change from baseline and 24-hour change from baseline compared with placebo.
Seelos further reported that SLS-002 was well-tolerated with no new safety signals or deaths reported; however, at least one treatment-emergent adverse event was recorded in 52.7% of those given treatment compared with 39.7% given placebo, though the majority of events recorded were of mild to moderate severity.
“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,” Tim Whitaker, MD, chief medical officer of Seelos, said in the release. "We believe these results demonstrate the therapeutic potential of SLS-002 to address this huge unmet need and those at risk.”