Sage expands into sleep disorders after early-phase success

Sage CEO Jeff Jonas (far right) and colleagues. (Sage Therapeutics)

Sage Therapeutics has added sleep disorders to the list of indications targeted by SAGE-217. The CNS specialist committed to initiating sleep disorder trials of the GABA receptor modulator after getting a look at data from a small study in healthy volunteers.

Investigators enrolled 45 people in the trial and gave them one of two single doses of SAGE-217 or placebo. The trial linked both SAGE-217 doses to statistically significant increases in the percentage of time participants were asleep while in bed, resulting in the study hitting its primary endpoint. Sage also chalked up wins against wake after sleep onset and total sleep time.

SAGE-217 came up short against a third secondary endpoint that assessed how long it took people to go to sleep. But, with the safety data coming in clean, Sage thinks the overall data package supports further trials in sleep disorders. Sage expects to start sleep disorder studies this year.

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As with many of the trials Sage has run to provide early validation of SAGE-217, the size of the phase 1/2—and, on this occasion, use of healthy volunteers—leaves questions about the efficacy of the drug unanswered. And the near-term significance of the data falls well short of the results Sage posted on the use of SAGE-217 in major depressive disorder late last year. 

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Nonetheless, the data represent another step forward for Sage’s attempts to show its lead asset acts on parts of the brain that are relevant to multiple major indications.

“Key to the experimental medicine capability at Sage is translating insights between compounds and indications for better odds of success across the pipeline. Our evaluation of SAGE-217 in multiple clinical trials, across several indications, suggests that the drug’s mechanism of action may rebalance fundamental brain circuitry,” Jim Doherty, Ph.D., chief research officer of Sage, said in a statement.

Sage’s decision to step up its interest in sleep disorders sees it join a small club of biotechs that are forging ahead in indications that are outside the R&D mainstream. Other notable names in the club include Idorsia, the biotech that spun out of Actelion when it was gobbled up by Johnson & Johnson. Idorsia’s dual orexin receptor antagonist hit the primary endpoint in two mid-phase trials last year.