Sage Therapeutics has suspended enrollment in two clinical trials of its depression drug in response to the failure of a phase 3 study. The action is intended to give Sage time to talk to the FDA and weigh potential amendments to the two paused phase 3 trials.
Late last year, Sage was rocked by the failure of SAGE-217 to beat placebo in a phase 3 trial of major depressive disorder patients. The setback wiped 50% off Sage’s share price and raised the possibility of changes to ongoing phase 3 trials, which are assessing GABA receptor positive allosteric modulator SAGE-217 in major depressive disorder patients with and without insomnia.
