Axsome Therapeutics Initiates Phase 2 Trial of AXS-05 in Major Depressive Disorder

Axsome Therapeutics (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, enrolled the first patient in the ASCEND (Assessing Clinical Episodes in Depression) study, a Phase 2 randomized, controlled trial of AXS-05 in major depressive disorder (MDD). AXS-05 is a novel, oral, glutamatergic and monoaminergic investigational medicine consisting of dextromethorphan and bupropion. Topline results from the ASCEND trial are expected in the second half of 2018.

As quoted in the press release:

AXS-05 is now being evaluated in two mood disorder clinical programs—MDD with the ASCEND Phase 2 trial, and treatment resistant depression (TRD) with the ongoing STRIDE-1 Phase 3 trial. MDD is characterized by consistently depressed mood that impairs functioning. Patients diagnosed with MDD are defined as having TRD if they have failed to respond to two or more antidepressant therapies.

“Axsome is committed to addressing the urgent need for new treatment options for the millions of patients living with depression,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “AXS-05 features multiple novel mechanisms of action which, along with the recent positive interim futility analysis of the Phase 3 trial in TRD, support its evaluation in the broader MDD population. AXS-05 is now being studied in four clinical trials across four indications. We look forward to a busy second half of 2018 for AXS-05, with anticipated topline results from the Phase 2 ASCEND trial in MDD, the first interim analysis of the Phase 2/3 ADVANCE-1 trial in Alzheimer’s disease agitation, and the next and final interim analysis for efficacy of the Phase 3 STRIDE-1 trial in TRD.”

Click here to read the full press release.