Brief

Sage forges ahead with depression drug after positive Phase 2 results

Dive Brief:

  • Sage Therapeutics touted Monday that one of its depression drugs had achieved its safety and efficacy goals of a mid-stage clinical trial.
  • The open-label study tested SAGE-217, a drug for major depressive disorder (MDD), in just 13 patients. Still, the treatment met its primary endpoint of being "generally well-tolerated with no serious adverse events or discontinuations reported," according to topline results. 
  • Due to the positive results, Sage plans to initiate a second part to the Phase 2 study after a detailed analysis of the first part is complete. The company said the later trial would be double-blind and placebo-controlled, but did not release additional details on timeline or structure.

Dive Insight:

Sage had a great 2016. Its lead candidate, SAGE-547, did well in mid-stage clinical testing as a treatment for severe postpartum depression. Those results gave credence to an expanded Phase 2 dosing trial, and boosted the company's stock 40%. Shares rose even further when the Food and Drug Administration accepted the development plan for the drug back in December.

That momentum has continued in 2017 as news of SAGE-217's success once again put the company in investors' good graces. Sage stock closed at $52.99 per share on Monday, an almost 12% jump from close-of-market Friday. Notably, the company, which went public in 2014, has seen its stock rise almost 200% from its initial $18 per share pricing.

Sage reported no serious or adverse effects from taking SAGE-217, though the small patient pool could have something to do with that. The most common adverse effects for SAGE-217 were dizziness, drowsiness, headache and muscle pain.

In addition to meeting the study's safety objectives, the drug also met a secondary endpoint: significant reduction from baseline depression as measured by the Hamilton Rating Scale for Depression (HAM-D).

The study's patients had a mean HAM-D score of 27.2 at baseline. After 15 days of orally taking SAGE-217 once a day, 11 of the 13 patients showed a 50% reduction in their HAM-D scores, while eight patients had scored low enough (at or below a 7 on the scale) to be considered in remission. Overall, HAM-D scores declined 19.9 points on average.

"Understanding the caveats associated with open-label data, we are highly encouraged by the strong signal we achieved in this study, which met our internal criteria for achieving a positive signal and thus supported our plan to proceed," Sage CEO Jeff Jonas said in a Feb. 13 statement.

Both SAGE-217 and SAGE-547 target one segment of gamma-aminobutyric acid (GABA), which works to regulate the body's central nervous system.

Treatments that target GABA receptors are rarer in the depression drug market, which may give Sage a leg up on the competition. Currently, there are a laundry list of other drugs that work on different proteins and neurotransmitters, including Cymbalta (duloxetine), Parnate (tranylcypromine),Norpramin (desipramine) and Wellbutrin (bupropion).

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Filed Under: Clinical Trials
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