Sage Therapeutics’ SAGE-217 missed its primary endpoint in a key Phase III trial for major depressive disorder (MDD), resulting in a major blow for the neurology-specialist company.

Although this does not scrap the pipeline asset from clinical trials, investors rapidly responded to this R&D setback by wiping out almost 60% off its share price.

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In March 2019, Sage Therapeutics’ Zulresso (brexanolone) gained FDA approval for postpartum depression, securing first-to-market position, but also the company’s first drug to reach the market. Subsequently, Sage Therapeutics was aiming to enter a bigger market, MDD, through the potential launch of SAGE-217.

Earlier this year, SAGE-217 met its primary and secondary endpoints in the Phase III ROBIN study in postpartum depression. It also demonstrated positive results from an earlier Phase II trial in severe MDD. SAGE-217 was viewed as being commercially attractive for the company, given that this drug is oral and would capture a much larger patient pool, while Zulresso’s high price point and a 60-hour infusion could hinder its uptake. Ultimately, SAGE-217 could have been a blockbuster, and its novel mechanism of action would have been well received in the crowded MDD market. As such, the company had high hopes, but trials for mood disorders are notoriously challenging.

The recent news demonstrated that SAGE-217 barely outperformed placebo in the pivotal Phase III MOUNTAIN trial for MDD. The company has noted that patient non-compliance could be to blame for these disappointing results. Additionally, selection factors could have influenced results, as the trial included a higher proportion of patients with less severe symptoms. Fortunately, SAGE-217’s safety profile was positive and the company is now waiting for data from the other studies the product is currently undergoing.

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