Seres begins Phase 1b trial of SER-262 for primary Clostridium difficile infection

Company notes that this will be the first-ever clinical study of a synthetic microbiome therapeutic

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CAMBRIDGE, Mass.—Seres Therapeutics Inc., a microbiome therapeutics company, announced July 7 that it has initiated a Phase 1b clinical trial evaluating SER-262 in patients with primary Clostridium difficile infection (CDI). SER-262 is an Ecobiotic rationally-designed, fermented microbiome therapeutic derived by a manufacturing process that does not require human donor material. SER-262 is the first synthetically-derived and designed microbiome therapeutic ever to reach clinical-stage development, the company says.
“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,” said Dr. Roger Pomerantz, president, CEO and chairman of Seres. “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.
SER-262, an oral capsule, contains a consortium of twelve bacterial strains in spore form. The strains included in SER-262 were selected based on multiple criteria including analysis of human microbiome data, efficacy in animal models of CDI, and bacterial strain level characterization. The composition of SER-262 was selected among Seres’ field-leading human microbiome library containing over 14,000 well-characterized strains of bacteria.
The SER-262 Phase 1b study, a 24-week randomized, placebo-controlled, dose escalation study, is expected to enroll approximately 60 patients who have experienced a first episode of CDI. The primary endpoint of the study will compare the CDI recurrence rate between the SER-262 and placebo groups at up to 8 weeks after dosing. Approximately 640,000 and 820,000 individuals in United Staes each year experience a primary occurrence of CDI, and about 25 percent will suffer from a subsequent recurrence.
With the initiation of the SER-262 Phase 1b study in primary CDI, and the ongoing SER-109 Phase 2 study in multiply recurrent CDI, Seres now has ongoing microbiome clinical programs across the entire CDI population. Initial study results from the SER-109 Phase 2 study are expected in mid-2016.
Seres aims to develop a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is imbalanced. Seres’ most advanced program, SER-109, has successfully completed a Phase 1b/2 study demonstrating a clinical benefit in patients with recurring CDI and is currently being evaluated in a Phase 2 study in that condition. The FDA has granted SER-109 Orphan Drug Designation and Breakthrough Therapy Designation. Seres’ second clinical candidate, SER-287, is being evaluated in a Phase 1b study in patients with mild-to-moderate ulcerative colitis.
Seres notes that CDI is one of the top three most urgent antibiotic-resistant bacterial threats in the United States, per data from the U.S. Centers for Disease Control and Prevention, and it is a rapidly growing problem associated with antibiotic use. It is a leading cause of hospital-acquired infection in the United States.
Meanwhile, in June, Seres announced a collaboration with Massachusetts General Hospital (MGH) of the Harvard Medical School to support translational research focused on identifying microbiome therapeutics for obesity and metabolic syndrome.
Under the terms of the agreement, Seres will help fund a placebo-controlled, proof-of-concept clinical study initiated by professors Dr. Elaine Yu, and Dr. Elizabeth Hohmann of MGH. The study will evaluate the impact of fecal microbiota transplantation (FMT) derived from lean individuals on the body weight and glycemic control of adults suffering from clinically-significant obesity and metabolic disorders, including insulin resistance and metabolic syndrome. As part of the collaboration, Seres will analyze patient samples to determine metagenomic signatures, metabolic markers and other key clinical biomarkers that are expected to inform the design of microbiome therapeutics for treatment of obesity and associated metabolic disease.
Previous clinical and preclinical evidence supporting this research indicated that the gut microbiota has a critical role in regulating human metabolism and weight control, via effects on caloric availability, chronic inflammation and the production of hormone-like small molecules, Seres noted.
“Drs. Yu and Hohmann are conducting groundbreaking research to elucidate the impact of gut bacteria on body weight and other metabolic parameters,” said Dr. David Cook, executive vice president of research and development and chief scientific officer of Seres. “While FMT is not a practical long-term clinical solution, FMT studies do provide important insights about the role of the microbiome in human health. We believe that this research will provide critical insights to support the development of new microbiome therapeutics for obesity.”
“Better treatment options are desperately needed to address obesity, and microbiome-based drugs are promising new approaches,” noted Hohmann. “In entering into this agreement with Seres, a leader in the development of microbiome therapeutics, we aim to advance our understanding of the role of the microbiome in obesity and related metabolic disorders and accelerate the development of meaningful new treatments for patients.”
In the July issue of DDNews, we will feature a news article, in our Research & Development sectino, about the company’s entrance into trio of strategic collaborations on infectious disease, immunologic disease and metabolic disease, with particular focus on microbiome research—MGH among those new partners.

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