This wasn’t a great week for shareholders of Sage Therapeutics (NASDAQ: SAGE). The biopharmaceutical company’s stock price was cut down by investors unimpressed with clinical trial results for its most promising asset. Shares of the biotech lost 28.2% of their value this week as the first of several important phase 3 studies for zuranolone produced lackluster results.
Zuranolone is an experimental tablet Sage Therapeutics is developing in partnership with Biogen (NASDAQ: BIIB). Sage and Biogen have invested heavily into four different phase 3 trials with zuranolone as a treatment for major depressive disorder (MDD) and postpartum depression (PPD).
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The stock was hit hard on Tuesday, June 15, after the company shared lackluster results from Waterfall, a study designed to support an application for the long-term treatment of millions of Americans with MDD. On the 50-plus point Hamilton Rating Scale for Depression or HAMD-17, patients randomized to receive zuranolone had scores that averaged 14.1 points lower on day 15 than at the beginning of the study.
Unfortunately for Sage Therapeutics, average scores from the placebo group fell by 12.3 points. An average difference of just 1.7 points over the placebo group for patients who began with HAMD-17 scores of at least 25 was statistically significant, but hardly anything for physicians with hard-to-treat MDD patients to get excited about.
Sage Therapeutics badly needs a win from zuranolone because its first drug to earn approval, Zulresso, hasn’t been as successful as hoped. First-quarter sales of the difficult-to-administer PPD drug fell to $1.6 million this year from a measly $2.3 million in the previous year period.
This week’s losses would have been much worse if not for SAGE-718. This is a potential new treatment for an array of cognitive disorders including Alzheimer’s disease, Huntington’s disease, and Parkinson’s disease.
Earlier this year, Sage Therapeutics reported encouraging data from an open-label trial with eight Huntington’s disease patients that took SAGE-718 daily for two weeks. If phase 2 studies already in the works provide confirmation, this troubled biotech stock could bounce back for patient shareholders. Trying to catch this falling knife, though, probably isn’t a good idea.
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