Benzinga | Aug 10, 2020 07:05AM EDT

Axsome Therapeutics Gives an Update on its AXS-05 Depression Clinical Program

Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, announces continued progress toward NDA filing of AXS-05 in the treatment of major depressive disorder (MDD), and the generation of new clinical data to further characterize the antidepressant profile of AXS-05 across a broad spectrum of patients with MDD.

Enrollment has been completed in the COMET (Clinical Outcomes with NMDA-based Depression Treatment) Phase 3open-label, long-term safety trial to support the planned NDA filing of AXS-05 in MDD. In addition, the required number of patients treated for 6 months has been reached. Filing of the NDA remains on track for the fourth quarter of 2020.

Axsome is also conducting three Phase 2 open-label efficacy sub-studies of the COMET trial which will evaluate the efficacy and safety of AXS-05 in three clinically pertinent MDD patient populations: the COMET-TRD trial in treatment resistant MDD (TRD), the COMET-AU trial in antidepressant unresponsive MDD, and the COMET-SI trial in MDD with suicidal ideation. Efficacy results from these studies are expected in the fourth quarter of 2020.

Further, Axsome has initiated the MERIT (Mechanistic Evaluation of Response in TRD) trial, a Phase 2, double-blind, placebo-controlled, randomized withdrawal study in patients with TRD. Results from the MERIT trial, which are expected in the first half of 2021, along with results from the COMET-TRD trial, which are expected in the fourth quarter of 2020, will provide clinically useful information with AXS-05 in this treatment resistant MDD population.