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Seres initiates first clinical trial of synthetic microbiome therapy for C. difficile

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Seres Therapeutics has initiated a phase 1b clinical trial of SER-262 in patients with primary Clostridium difficile infection. This is the first synthetic microbiome therapeutic to reach clinical-stage development, according to a press release.

“Advancing SER-262 to the clinic is a landmark event for Seres and the microbiome field in general. The SER-262 program has demonstrated our ability to rapidly develop a new class of synthetic microbiome therapeutics comprised of rationally designed bacterial compositions,” Roger Pomerantz, MD, president, CEO and Chairman of Seres, said in the press release.

SER-262 is an oral capsule containing spores of twelve bacterial strains, which were selected based on human microbiome data, efficacy in animal models and bacterial strain level characterization. These data were presented in a poster at ASM Microbiome 2016. Its composition was selected from more than 14,000 well-characterized bacterial strains.

The company expects about 60 patients with primary C. difficile infection to be enrolled in the 24-week randomized, placebo-controlled, dose escalation study, in which the rate of recurrence at up to 8 weeks will serve as the primary endpoint.

“We intend to continue to utilize our platform technology and unique knowledge of bioinformatics, microbiology, manufacturing and regulatory requirements to develop additional rationally designed microbiome therapeutics for serious diseases in each of our three therapeutic franchises: infectious disease, immunology and metabolic disease,” Pomerantz said in the release.

The company also reported that initial results from its ongoing phase 2 trial of SER-109 in multiple recurrent C. difficile infection are expected in mid-2016.

Disclosures: Pomerantz is employed by Seres Therapeutics.