Axsome Therapeutics: AXS-05 achieves primary endpoint in Phase 3 trial, Shares jump 77%
Axsome Therapeutics (AXSM) announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the primary endpoint and rapidly and significantly improved symptoms of depression in the GEMINI Phase 3 trial in major depressive disorder.
The GEMINI study was a randomized, double-blind, placebo-controlled, multi-center, U.S. trial, in which 327 adult patients with confirmed moderate to severe MDD were randomized to treatment with either AXS-05 or placebo once daily for the first 3 days and twice daily thereafter for a total of 6 weeks.
AXS-05 met the primary endpoint by demonstrating a highly statistically significant reduction in the Montgomery-Asberg Depression Rating Scale total score compared to placebo at Week 6, with mean reductions from baseline of 16.6 points for AXS-05 and 11.9 points for placebo.
AXS-05 rapidly and durably improved depressive symptoms as compared to placebo with statistical significance on the MADRS total score demonstrated at Week 1, the earliest time point assessed, and at all time points thereafter.
Rates of remission from depression were statistically significantly greater for AXS-05 compared to placebo at Week 2 and at every time point thereafter, being achieved by 39.5% of AXS-05 patients compared to 17.3% of placebo patients at Week 6.
AXS-05 demonstrated rapid onset of action with statistically significant improvement as compared to placebo on numerous endpoints at Week 1, or only 4 days after the start of twice daily dosing.
Statistically significant improvements at Week 1 were observed for MADRS total score; Patient Global Impression-Improvement; Clinical Global Impression-Severity; Clinical Global Impression-Improvement; Quick Inventory of Depressive Symptomatology-Self-Rated; Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form; and other endpoints.
On all secondary endpoints including the following, AXS-05 demonstrated statistically significant improvement at Week 6 compared to placebo, reflecting increasing treatment effects over time: clinical response on the MADRS total score; PGI-I; CGI-S; CGI-I; QIDS-SR-16; Sheehan Disability Scale; and Q-LES-Q-SF.
AXSM is up 77% to $82.66.
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