Date: 2015-05-28
Type of information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: Seres Therapeutics (USA - MA)
Product: SER-109 - encapsulated spores from fecal microbiota
Action
mechanism: microbiome therapeutic. SER-109 is the lead Seres Ecobiotic® microbiome therapeutic in clinical testing for the treatment of recurrent Clostridium difficile infection (CDI). SER-109 was developed utilizing the Seres Microbiome Therapeutics™ platform that provides deep insight into the ecologies of disease and then identifies microbial compositions that can catalyze a shift to health.
Disease: prevention of recurrent Clostridium difficile infection (CDI) in adults
Therapeutic area: Infectious diseases
Country: USA
Trial
details: The Phase 2 study is a multicenter, randomized, placebo-controlled study that will evaluate the efficacy and safety of SER-109. The primary outcome measure is the absence of clinically-significant CDI through eight weeks following administration of SER-109 compared to placebo. SER-109 will be administered orally as a single dose, following the standard of care antibiotics for CDI (NCT02437487)
Latest
news: * On May 28, 2015, Seres Therapeutics, a leading microbiome therapeutics platform company, announced the enrollment and dosing of the first patient in its Phase 2 clinical study of SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (CDI) in adults. The objective of the Phase 2 study is to further assess the efficacy and safety of SER-109, Seres’ leading development candidate. Results from the Phase 1b/2 study of SER-109 in recurrent CDI patients showed that 87 percent of patients met the primary study endpoint and 97 percent of patients achieved a clinical cure, which was defined as the absence of CDI requiring antibiotic treatment during the eight-week period after SER-109 dosing.
The Phase 2 study is a multicenter, randomized, placebo-controlled study that will evaluate the efficacy and safety of SER-109. The primary outcome measure is the absence of clinically-significant CDI through eight weeks following administration of SER-109 compared to placebo.The study is actively enrolling and will be conducted at approximately 35 centers across the U.S. The read-out from the Phase 2 study is currently expected in the middle of 2016.
