Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, enrolled the first patient in its GEMINI (Glutamatergic and Monoaminergic Modulation in Depression) study, a Phase 3, randomized, double-blind, placebo-controlled trial of AXS-05 in the treatment of major depressive disorder (MDD). AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity. Topline results from the GEMINI trial are anticipated in the second half of 2019.
“Initiation of the placebo-controlled GEMINI Phase 3 trial continues the expedited clinical development of AXS-05 in depression. If successfully developed, AXS-05 has the potential to be the first orally administered NMDA receptor antagonist approved for the treatment of this debilitating condition,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “Based on the results of our recent FDA Breakthrough Therapy meeting for AXS-05, we believe that either the GEMINI study in MDD or the ongoing STRIDE-1 trial in treatment resistant depression, if positive, would, in conjunction with our previously completed ASCEND trial in MDD, be sufficient to support the filing of an NDA for AXS-05 for the treatment of MDD. We continue to anticipate topline results from both the STRIDE-1 and GEMINI trials in the second half of 2019.”
In March 2019, Axsome received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for AXS-05 for the treatment of MDD.
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