Sage rethinks SAGE-217 program after phase 3 failure

Sage Therapeutics
Sage Therapeutics' team (Sage Therapeutics)

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.

Sage took action swiftly after the phase 3 failure, suspending enrollment in both studies in a little over one month. The biotech quietly shared details of the actions by changing the statuses for the two suspended studies pending the evaluation of potential amendments. 

In fourth-quarter results posted Thursday, Sage confirmed the suspensions of the trials but held off on committing to next steps for SAGE-217. Sage is still going over data from the failed phase 3 and is waiting until the completion of interactions with the FDA before setting out the future for SAGE-217.

Sage’s interest in finding a path forward for SAGE-217 reflects its view that the data from the phase 3 trial feature some encouraging signs. In disclosing the results in December, Sage zeroed in on post hoc analyses that suggested noncompliance with the treatment regimen may have contributed to the failure. The post hoc analyses also suggested limited efficacy in people with mild symptoms may have dragged down the overall results.

The fourth-quarter results release featured other updates to Sage’s pipeline. Sage outlined plans to run a phase 2 trial of SAGE-324 in patients with essential tremor in the first half of 2020. SAGE-324 recently came through a phase 1 open-label study, results from which are slated for publication later in the year.

Sage is also gearing up to take SAGE-718 into one or more phase 2 trials this year. Having completed a phase 1 trial in Huntington’s disease patients late last year, Sage thinks the drug may have a future in neuropsychiatric disorders including Parkinson’s disease and Alzheimer’s disease.