Axsome Therapeutics Announces Positive Outcome of Interim Analysis of STRIDE-1 Phase 3 Trial of AXS-05

Axsome Therapeutics (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced a positive outcome of the interim futility analysis for the STRIDE-1 Phase 3 trial of AXS-05 in treatment resistant depression. An independent data monitoring committee (IDMC) conducted the unblinded, pre-specified interim analysis. Based on the results of the analysis, the IDMC recommended that the trial continue.

As quoted in the press release:

AXS-05 is a novel, oral, fixed-dose combination of dextromethorphan and bupropion. AXS-05 combines glutamatergic and monoaminergic mechanisms of action, which have been associated with antidepressant effects, and Axsome’s metabolic inhibition technology. Pharmacokinetic data with AXS-05 and clinical observations with the dextromethorphan component indicate that AXS-05 increases dextromethorphan concentrations into a potentially therapeutic range. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of treatment resistant depression.

“The positive outcome of this interim futility analysis combined with the multiple mechanisms of action of AXS-05 support its continued development for treatment resistant depression,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We look forward to the next and final interim analysis of the STRIDE-1 trial, anticipated in the second half of this year, which will be conducted to assess efficacy.”

Click here to read the full press release.