Axsome Therapeutics Announces Topline Results of the STRIDE-1 Phase 3 Trial in Treatment Resistant Depression and Expert Call to Discuss Clinical Implications

Achieves key secondary endpoints demonstrating rapid and statistically significant improvements in depressive symptoms on MADRS versus active comparator at Weeks 1, 2, and overall (key secondary endpoints, p=0.02, 0.035, and 0.031)

Demonstrated numerical improvement on primary endpoint (MADRS at Week 6) versus active comparator, but did not reach statistical significance (p=0.12)

Rapid and statistically significant remission of depression achieved versus active comparator starting at Week 1 (p=0.001, QIDS-SR-16)

Statistically significant improvement in cognitive function (p=0.011) and anxiety (p=0.009, HAM-A) versus active comparator

Data support continued development in TRD with initiation of second Phase 3 trial anticipated 3Q 2020

NDA filing for Breakthrough Therapy-designated AXS-05 in MDD on track for 4Q 2020

Topline results for ADVANCE-1 pivotal trial of AXS-05 in Alzheimer’s disease agitation on track for early 2Q 2020

Company to host conference call with Dr. Maurizio Fava today at 8:00 AM ET

NEW YORK, March 30, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced 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, 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 (45 mg dextromethorphan/105 mg bupropion) or 150 mg bupropion, twice daily for 6 weeks.

AXS-05 rapidly and significantly improved symptoms in patients with TRD as measured by MADRS averaged over the entire 6-week treatment period, a key secondary endpoint, with mean reductions of 8.6 for AXS-05 versus 6.7 for bupropion (p=0.031). The rapid onset of action with AXS-05 treatment was demonstrated with statistically significant mean MADRS reductions at Week 1, the earliest time point measured, of 5.2 versus 3.6 respectively for AXS-05 and bupropion (p=0.02), and at Week 2 of 8.0 versus 6.1 respectively for AXS-05 and bupropion (p=0.035), both time points being key secondary endpoints. At Week 6, the primary endpoint, AXS-05 demonstrated a numerically greater improvement in MADRS, with mean reductions of 11.6 for AXS-05 versus 9.4 for bupropion (p=0.117).