Seres Therapeutics Stock Plunges As Ulcerative Colitis Candidate Disappoints In Mid-Stage Study

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  • Seres Therapeutics Inc 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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