A Phase 3 clinical trial, MOUNTAIN, evaluating Sage Therapeutics’ (NASDAQ:SAGE) GABA modulator SAGE-217 in adults with major depressive disorder (MDD) failed to achieve the primary endpoint.
Specifically, SAGE-217 did not sufficiently separate from placebo as measured by a scale called HAM-D total score at day 15. Patients receiving 30 mg once daily experienced a mean reduction of 12.6 in HAM-D total score versus 11.2 for control (p=0.115), although statistically significant reductions were observed at days 3,8 and 12 (p<0.018 at each timepoint).
A post-hoc analysis revealed that ~9% of patients in the treatment group had no measurable drug concentration implying non-compliance. Excluding these, the separation from placebo was statistically valid at day 15 (p<0.048).
The 20 mg dose failed to sufficiently separate from placebo.
On the safety front, the company says SAGE-217 was generally well-tolerated. The incidence of adverse events during the 14-day treatment period and the 28-day follow-up period was 54.2% for the 30 mg dose, 50.0% for the 20 mg dose and 48.9% for placebo. Two participants receiving 30 mg experienced serious adverse events: one suicide attempt at day 5 (patient has a long history of MDD and a past suicide attempt) and one report of a bile duct stone after day 2 that required removal.
Detailed results will be submitted for presentation at a future medical conference.
Another Phase 3 in MDD is in process with an estimated completion date of April 2021.
In January, the company announced a positive outcome in a Phase 3 study, ROBIN, in women with postpartum depression.
Management will host a conference call this morning at 8:30 am ET to discuss the results.
Shares down 53% premarket on light volume.
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