Seres Therapeutics Reports P-III Trial (ECOSPOR IV) Results of SER-109 for the Prevention of Recurrent C. Difficile Infection
Shots:
- The P-III trial (ECOSPOR IV) evaluating ER-109 vs PBO in 263 patients. The results showed that patients remained free of C. difficile inf. recurrence @8 & 24wks. (91.3% & 86.3%) supporting the positive data of the P-III study (ECOSPOR III) published in JAMA, similar results were seen in all subgroups, incl. those with a single recurrence of CDI
- The therapy showed a well-tolerated safety profile which was consistent with the (ECOSPOR III) trial & no TRAEs led to withdrawal from the study. The results were published in JAMA Network Open
- SER-109 showed rapid & steady improvement in HRQOL over PBO @8wks., acc. to secondary data analysis from (ECOSPOR III) study. The BLA of SER-109 has been submitted to the US FDA & was accepted for Priority Review with an anticipated PDUFA date of Apr 2023
Ref: Business Wire | Image: Seres Therapeutics
Related News:- Nestle and Seres Collaborate to Jointly Commercialize SER-109 for Recurrent Clostridioides difficile Infection
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