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Axsome's Phase 3 Trial On Treatment Resistant Depression Fails To Meet Main Goal

Axsome Therapeutics Inc. (AXSM) said that the STRIDE-1 Phase 3 Trial did not reach statistical significance on the Week 6 primary endpoint on the Montgomery-Åsberg Depression Rating Scale or MADRS. The trial evaluated the company's AXS-05, an NMDA receptor antagonist with multimodal activity.

But, AXS-05 met key secondary endpoints in the trial by rapidly and statistically significantly improving symptoms of depression on the Montgomery-Åsberg Depression Rating Scale or MADRS, as early as Week 1 and for the overall 6-week treatment period, as compared to the active comparator bupropion in patients with treatment resistant depression or TRD.

In Monday pre-market trade, AXSM is trading at $52.75, down $10.52 or 16.63 percent.

STRIDE-1 was a randomized, double-blind, active-controlled, multi-center, U.S. trial, in which 312 adult patients with confirmed TRD, who had failed two or three prior treatments, were randomized to treatment with either AXS-05 or 150 mg bupropion, twice daily for 6 weeks.

Axsome plans to initiate a second Phase 3 trial of AXS-05 in patients with treatment resistant depression in the third quarter of 2020.

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