Axsome, Sage Therapeutics Move On Positive Results From Depression Drug Studies

Shares of Axsome Therapeutics Inc AXSM and SAGE Therapeutics Inc SAGE were moving sharply higher Monday on separate clinical trial results. 

Axsome's Major Depressive Disorder Drug Trial

Axsome said its lead pipeline asset AXS-05 met its primary endpoint of achieving statistically significant reduction in the Montgomery-Asberg Depression Rating Scale total score averaged over a six-week treatment period vs. the widely used antidepressant bupropion.

AXS-05 is a NMDA receptor antagonist that was evaluated in a Phase 2 trial dubbed ASCEND for treating major depressive disorder, or MIDD. 

The drug was also found to be superior to bupropion on multiple pre-specified secondary endpoints, and the company said it was safe and well-tolerated, with no serious adverse events.

Axsome said the data backs the development of AXS-05 in treatment-resistant depression and further development in MDD.

As a way forward, the company said it will present detailed results from the ASCEND trial at upcoming scientific meetings.

AXS-05 is also being evaluated in a late-stage trial for treatment-resistant depression — defined as patients with MDD who have failed two or more antidepressant treatments.

The candidate has received Fast Track designation for this indication.

Axsome intends to meet with the FDA to discuss a potential regulatory path for the MDD indications.

Sage's Postpartum Drug Found Safe, Effective

Sage said its late-stage ROBIN trial that evaluated SAGE-217 in a 30-mg dose for depressive symptoms in women with postpartum depression, or PPD, showed a statistically significant improvement in the Hamilton Rating Scale for Depression was achieved compared to a placebo following two weeks of outpatient treatment.

Remission was achieved in 45 percent of patients treated with SAGE-217 for two weeks compared with 23 percent of patients receiving a placebo, the company said.

Secondary endpoints were statistically significant and consistent with the primary endpoint, Sage said. 

"This is our fifth consecutive positive study in mood disorders with our investigational medicines that utilize our innovative approach to GABA receptor modulation," CEO Jeff Jonas said in a statement. 

Axsome shares were skyrocketing 123.19 percent to $5.87 at the time of publication, while Sage shares were up 45.85 percent at $142.22. 

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