Sage Therapeutics Shares Toppled By Failed Mountain Study Of Depression Drug

Shares of thinly-traded SAGE Therapeutics Inc NASDAQ: SAGE) are melting down after the company flunked in a late-stage trial of its lead CNS disorder drug candidate SAGE-217 in major depressive disorder, or MDD.

What Happened To SAGE-217?

Sage said its pivotal Phase 3 MOUNTAIN study evaluating the effect of SAGE-217 on depressive symptoms in adults with MDD did not meet the primary endpoint of a statistically significant reduction from the baseline compared to placebo in the 17-item Hamilton Rating Scale of Depression, HAM-D, total score at Day 15.

SAGE-217, 30 mg, when given once-daily, as an oral treatment produced a mean reduction of 12.6 in HAM-D score compared to 11.2 for placebo. However, at Days 3, 8 and 12, SAGE-217 showed statistically significant reductions in HAM-D score.

Incidentally, Sage said in mid-January its SAGE-217 aced a late-stage trial that evaluated it for post-partum depression, or PPD, meeting both primary and secondary endpoints.

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What's Next For Sage

The company said post-hoc analysis of the MOUNTAIN study showed about 9% of patients in the 30mg group have no measurable drug concentration, which tantamounts to non-compliance with respect to the dosing.

"This study did not meet the primary endpoint. With that, the data are supportive of the activity of SAGE-217 in MDD given the statistical significance at the majority of timepoints, and in relevant populations," said CEO Jeff Jonas.

"As a designated breakthrough therapy, we are evaluating the path forward to more fully inform a potentially expedited pathway to approval, and any amendments we might consider to the ongoing SAGE-217 pivotal program," said Steve Kanes, Chief Medical Officer at Sage.

The company is also evaluating SAGE-217 in separate late-stage studies in insomnia and treatment-resistant depression.

Sage's stock tumbled 55% to $68 per share at time of publication.