Axsome Therapeutics Provides Year End 2018 Clinical Update

Axsome Therapeutics (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today provided the following clinical update for its robust CNS pipeline:

As quoted in the press release:

Axsome is evaluating AXS-05 (dextromethorphan/bupropion) in the following indications: treatment resistant depression, major depressive disorder, Alzheimer’s disease agitation, and smoking cessation.

Treatment Resistant Disorder

To date, just under 90% of the target number of subjects have been randomized in the Phase 3 STRIDE-1 trial in treatment resistant depression (TRD), with topline results anticipated in the first quarter of 2019. STRIDE-1 is a multicenter, randomized, double-blind, controlled trial in which subjects with TRD are randomized to treatment with AXS-05 or bupropion. A positive interim futility analysis was previously announced for the STRIDE-1 trial. The interim analysis was conducted by an independent data monitoring committee (IDMC) which recommended continuation of the study. Axsome has received U.S. Food and Drug Administration (FDA) Fast Track designation for AXS-05 for the treatment of TRD.

Major Depressive Disorder

Axsome has completed enrollment in the Phase 2 ASCEND study in major depressive disorder (MDD), and is on track to announce topline results in early January 2019, as previously disclosed. ASCEND is a multicenter, randomized, double-blind, controlled trial in which subjects with MDD are randomized to treatment with AXS-05 or bupropion.

Click here to read the full press release.