Axsome Therapeutics Second Quarter Update

Axsome released their second quarter results this morning, and an additional press release updating their depression clinical program here AXS-05 Depression Clinial Program. The company accomplished a significant amount of progress on all fronts. This post will focus on the companies lead drug AXS-05 for Treatment Resistant Depression or TRD. Summary below.

COMET TRD Trial - A phase 2 an open label sub-study evaluating the efficacy and safety in TRD patients. Approximately 70 patients will be enrolled. The trial endpoints will include the change from baseline in the Montgomery Asberg Depression Rating Scale or (MADRS) total score, clinical response and remission. Topline results from the COMET-TRD is expected in the fourth quarter of 2020.

MERIT Trial - A phase 2 double blind placebo controlled trial randomized withdrawal study in patients with TRD. Approximately 50 patients will be enrolled. The primary endpoint of the trial is the time to relapse of depressive symptoms. Topline first half 2021.                                           

AXS-12 Breakthrough Therapy Designation

The FDA has granted Axsome Therapeutics the Breakthrough Therapy Designation (BTD) for drug AXS-12 for the treatment of Narcolepsy. This was based off a phase 2 clinical trial completed in 2019, with results here AXS-12 Phase 2 Results. The designation allows for potentially quicker FDA approval of the drug, and increased communication from the FDA. The company is planning for phase 3 testing to begin in the fourth quarter of 2020.