Shares of Axsome Therapeutics Inc soared Monday after the biopharmaceutical company unveiled rosy trial results for a drug that addresses depression.
AXS-05, a key drug in Axsome’s pipeline which consists of dextromethorpan and bupropion, significantly improved symptoms of depression in a trial evaluating 80 adults after six weeks compared to the anti-depressive bupropion on its own. The company said AXS-05 was safe and well tolerated with no serious adverse events.
The results were met with enthusiasm by investors who sent Axsome shares up 167% to $7.02 in afternoon trade on Monday.
The company said that AXS-05 met the prespecified primary endpoint by demonstrating a statistically-significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score when measured against bupropion.
“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,” noted Dr Maurizio Fava, executive vice chair with the Department of Psychiatry at Massachusetts General Hospital, in a statement.
Fifty-one percent of patients in the trial had experienced three or more major depressive episodes prior to enrollment. Twenty-three percent of study participants had received first line treatment in their current major depressive episode prior to treatment with study medication.
The detailed results of the trial are expected to be presented at upcoming scientific meetings. AXS-05 is also being evaluated in a Phase 3 trial for patients with treatment-resistant depression or patients fighting depression who have failed two or more antidepressant treatments; the drug has already been granted fast track status by the US Food and Drug Administration in this area.
Contact Ellen Kelleher at [email protected]