Axsome Therapeutics Inc. (NASDAQ: AXSM) shares absolutely exploded on Monday after the company announced that its midstage trial in patients with major depressive disorder (MDD) met its primary endpoint.
Not only did the firm’s Phase 2 Ascend trial of AXS-05 in MDD meet the prespecified primary endpoint, but it also significantly improved symptoms of depression.
AXS-05 demonstrated a highly statistically significant reduction in the Montgomery-Åsberg Depression Rating Scale total score, averaged over the six-week treatment period, as compared to the antidepressant bupropion.
At week 6, 47% of patients who received AXS-05 achieved remission, compared with 16% of patients who received bupropion.
AXS-05 is also being evaluated in the Stride-1 Phase 3 trial in patients with treatment-resistant depression (TRD), defined as patients with MDD who have failed two or more antidepressant treatments. AXS-05 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of TRD. Considering the results of the Ascend trial, Axsome intends to meet with the FDA to define the potential regulatory path for the broader MDD population.
Professor Maurizio Fava, M.D., executive vice chair, Department of Psychiatry, Massachusetts General Hospital and associate dean for Clinical & Translational Research, Harvard Medical School, commented:
The clinically meaningful improvements in depressive symptoms seen with AXS-05 in this study were achieved versus an active comparator that is a well-established antidepressant, as early as only one week after initiation of treatment. Data show currently marketed antidepressants fail to provide adequate treatment response in about two thirds of treated patients. An estimated 16 million Americans suffer from major depressive disorder each year. As an oral NMDA receptor antagonist with multimodal activity, AXS-05 could provide a new approach to treating this potentially life-threatening condition.
Shares of Axsome were last seen up about 140% at $6.30, with a 52-week range of $1.94 to $7.24. The stock has a consensus analyst price target of $19.00.