- Shares in Sage Therapeutics Inc. surged Thursday on news the company's potential treatment for major depressive disorder, SAGE-217, significantly reduced symptoms from baseline over 14 days compared to placebo. Sage stock continued rising on Friday to reach near $170 per share, up 84% from Wednesday's close.
- Improvements in symptoms, as measured by a rating scale known as HAM-D, began from the day after the first dose through to week four, two weeks after finishing treatment. The improvements remained greater than placebo through to the end of week six.
- After two weeks of treatment, 64% of patients were in remission, compared with 23% on placebo. There were no serious or severe adverse events, and discontinuations were low. SAGE-217 has Fast Track designation.
Sage's shares have been up and down this year, rising 10% in February on rumors of a merger, tumbling 20% in September after the failure of brexanolone in epilepsy in Phase 3, and rising again by 50% as brexanolone showed significant improvements in postpartum depression. None of the rises were quite as dramatic as the bump Thursday.
Sage was founded in 2011, and the treatment was developed in-house. The company's focus is on next-generation modulators of the GABA system, and the company believes that SAGE-217 has potential to "offer the first truly new mechanism of action in the pharmacologic treatment of depression in more than 20 years."
What could give Sage the edge is the speed of onset of symptom relief, the lack of increased risk of suicide and sedation, and the high rate of remission after only two weeks. Existing antidepressants can take weeks to work, which can be very difficult for patients suffering from moderate or severe depression and finding it hard to function. Some are implicated in the increased risk of suicide.
"These very encouraging data suggest the potential of SAGE-217 in the treatment of MDD as well as other mood-related disorders that we may pursue," said Jeff Jonas CEO of Sage Therapeutics. "The positive activity and safety findings of SAGE-217 in MDD support advancing the program into later stage clinical development and we will work with the FDA to determine next steps in the further development of SAGE-217."
The treatment is also in Phase 2 trials for severe postpartum depression, essential tremor and Parkinson's disease.