Previously completed active-controlled ASCEND trial in MDD now considered as pivotal; sufficient with ongoing STRIDE-1 Phase 3 trial for NDA in MDD
Target randomization for STRIDE-1 Phase 3 trial reached; screening to continue to build required NDA safety database
Initiation of placebo-controlled Phase 3 trial in MDD anticipated in 2Q 2019; provides additional NDA path with ASCEND trial and builds required NDA safety database
Topline results of both STRIDE-1 Phase 3 trial in TRD and planned placebo-controlled Phase 3 trial in MDD expected in 2H 2019
AXS-05 has potential to be first oral NMDA receptor antagonist with multimodal activity for the treatment of depression
Company to host conference call today at 8:00 AM Eastern
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 the development status and plan for AXS-05 in the treatment of major depressive disorder (MDD) and treatment resistant depression (TRD) have been expedited following a Breakthrough Therapy meeting with the U.S. Food and Drug Administration (FDA). AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity.
As part of the expedited development program, the Company’s previously completed ASCEND trial in MDD is now considered sufficient with the ongoing STRIDE-1 Phase 3 trial in TRD, if positive, to support the filing of an NDA (New Drug Application) for approval of AXS-05 for the treatment of MDD. Alternatively, Axsome may file an NDA for AXS-05 for the treatment of MDD with the completed ASCEND trial and a placebo-controlled Phase 3 trial of AXS-05 in MDD. Axsome intends to initiate this placebo-controlled Phase 3 MDD trial in the second quarter of 2019.
Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss the expedited development plan for AXS-05 in the treatment of major depressive disorder following a Breakthrough Therapy meeting with the FDA. To participate in the live conference call, please dial (844) 698-4029 (toll-free domestic) or (647) 253-8660 (international), and use the conference ID 3977129. The live webcast can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at axsome.com. A replay of the webcast will be available for approximately 30 days following the live event.
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