Seres Therapeutics Stock Plunges As Ulcerative Colitis Candidate Disappoints In Mid-Stage Study
- Seres Therapeutics Inc (NASDAQ: MCRB) has announced topline results from the Phase 2b ECO-RESET study evaluating SER-287 in patients with mild-to-moderate ulcerative colitis (UC).
- The study did not meet its primary endpoint of improving clinical remission rates compared to placebo.
- Given the lack of a clinical efficacy signal identified in ECO-RESET, the Company has decided to close the study's open-label and maintenance portions.
- Microbiome endpoints and analyses are expected in the second half of 2021.
- No meaningful clinical differences and no statistical significance were observed in absolute clinical remission rates among the three treatment arms (10.3% for the full induction dose, n=68 and 10.6% for the step-down induction dose, n=66 versus 11.6% for placebo, n=69).
- There were also no meaningful differences observed across the three treatment groups for endoscopic improvement, endoscopic remission, or symptomatic remission.
- Treatment-emergent adverse events (AEs) were observed in 67.6%, 46.2%, and 50.7% of subjects in the induction dose, step-down, and placebo treatment arms, respectively.
- The majority of observed AEs were mild or moderate in intensity.
- Both dosing regimens of SER-287 were generally well tolerated.
- Price Action: MCRB shares are down 37.60% at $13.00 during the premarket session on the last check Thursday.
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