Axsome sees mixed top-line Ph III results with AXS-05 in TR depression

USA-based CNS specialist biotech Axsome Therapeutics (Nasdaq: AXSM) fell almost 15% after it revealed that its depression drug candidate AXS-05 had failed to achieve its primary endpoint in a Phase III study. The stock closed down 9% at $57.58 on Monday.

The company noted, however, that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met key secondary endpoints in the STRIDE-1 trial by rapidly and statistically-significantly improving symptoms of depression on the Montgomery-Åsberg Depression Rating Scale (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 (TRD).

The STRIDE-1 trial did not reach statistical significance on the Week 6 primary endpoint on MADRS. STRIDE-1 was a randomized, double-blind, active-controlled, multi-center, US 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 (45mg dextromethorphan/105mg bupropion) or 150mg bupropion, twice daily for 6 weeks.