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Oral Microbiome-Based Therapeutic Safely Treated C. difficile Infection
A novel oral microbial therapeutic safely and effectively treated recurrent Clostridium difficile infection, according to results from a phase 1/2 clinical study recently presented at the American Gastroenterological Association’s James W. Freston Conference in Chicago.
“Working with Seres Health, we were able to design what we call an ‘Ecobiotic’ therapeutic product,” Sahil Khanna, MBBS, of Mayo Clinic told Healio Gastroenterology.
Sahil Khanna
SER-109 is an “ecology of commensal spores” that can be delivered in capsule form to treat patients with recurrent C. difficile infection (CDI), Khanna said, “and it seems to have very good efficacy in the initial pilot study that we did, with a 100% cure rate.”
Khanna and colleagues performed a single-arm, open-label study of SER-109 in 15 patients (mean age, 64 years; 67% women) with recurrent CDI. The mean number of previous CDI episodes per patient was 3.8. By the end of the 8-week posttreatment study period, all patients were cleared of CDI with no drug-related serious adverse events.
“[SER-109] circumvents a lot of different issues that come with fecal transplant, namely procuring donor stool, and the need to test every single donor,” due to its novel methodology of delivery, and the ability to eliminate potential pathogens, Khanna said.
“[This study was] not blinded and not placebo-controlled … so the next step is a phase 3 trial, which is in the works,” he said. “[SER-109] has the potential to replace conventional fecal transplantation in the long run.” – by Adam Leitenberger
Disclosure: Khanna reports no relevant financial disclosures, but reports previously serving as a consultant for Optimer Pharmaceuticals (now Cubist Pharmaceuticals.)