Axsome Therapeutics (NASDAQ:AXSM) is up 56% premarket on the heels of AXS-05, an oral, investigational NMDA receptor antagonist with multimodal activity, meeting primary endpoint in the GEMINI Phase 3 trial in major depressive disorder (MDD).
The study enrolled 327 patients. AXS-05 met the primary endpoint by demonstrating a highly statistically significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) 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 (p=0.002).
AXS-05 rapidly and durably improved depressive symptoms as compared to placebo with statistical significance on the MADRS total score demonstrated at Week 1 key secondary endpoint, p=0.007).
Statistically significant improvement for AXS-05 was observed versus placebo on all secondary endpoints at week 6, including remission (p<0.001), disease severity (p=0.002), functional impairment (p=0.002), and quality of life (p=0.011).
Axsome plans to file NDA for AXS-05 in H2 2020.
AXS-05 is covered by 41 issued U.S. and international patents providing protection out to 2034, and maintains worldwide rights.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.