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Phase III ECOSPOR III study of SER 109 shows efficacy to 24 weeks in C. difficile infection.- Seres Therapeutics

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Published:24th May 2021
Seres Therapeutics announced the presentation of its final 24-week data from the pivotal Phase III ECOSPOR III study evaluating SER 109, an investigational oral microbiome therapy for recurrent C. difficile infection (rCDI).

Final 24-week efficacy and safety results from the SER-109 ECOSPOR III Phase III study ( identifier: NCT03183128), a multicenter, randomized, placebo-controlled study that enrolled 182 patients with multiple rCDI, indicate that SER 109 was observed to maintain durable efficacy at 24 weeks following dosing, resulting in reducing the risk of rCDI compared with placebo. The safety profile observed to date has been comparable to placebo. Significantly fewer patients administered SER-109 experienced rCDI compared to the placebo arm at Week 24 (21.3% vs. 47.3%, p-value <0.001), a relative risk reduction of 54%. ser 109 resulted in a 26% absolute reduction of recurrence of cdi compared to placebo at 24 weeks post-treatment. this is comparable to the 27% absolute reduction of recurrence observed in the trial at week 8. in the phase iii study, ser 109 was observed to be well tolerated, with the overall incidence of adverse events at week 24 comparable between the ser 109 and placebo arms. treatment-emergent serious adverse events (saes) were observed in the active arm at a rate lower than in the placebo arm (n="15," 16.7%; n="19," 20.7%). the data was presented in a poster of distinction at digestive disease week 2021.></0.001),>

Condition: Infectious Diseases/Clostridium
Type: drug

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