U.S. Food and Drug Administration (FDA) Grants Orphan Drug Designation To Seres Therapeutics SER-287 For Treatment of Ulcerative Colitis In Pediatric Patients

Seres Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to microbiome therapeutic candidate SER-287 for the treatment of Ulcerative Colitis (UC) in pediatric patients.

Orphan Drug Designation provides incentives designed to advance drug development for rare diseases or conditions that affect fewer than 200,000 people in the United States. The FDA’s designation of SER-287 follows a review of data which established a medically plausible basis for the use of SER-287 – specifically, the Phase 1b clinical data that highlights the potential of SER-287 as a novel treatment modality for patients suffering from UC.

Seres successfully completed a placebo-controlled Phase 1b study of SER-287 in patients with mild-to-moderate UC who were failing current therapies. SER-287 administration resulted in a dose-dependent improvement of both clinical remission rates and endoscopic scores, and demonstrated a very favorable safety profile. The Phase 1b results demonstrate the potential for SER-287 to provide an effective and safer alternative treatment modality for patients suffering from UC. SER-287 Phase 1b microbiome data are expected in early 2018.

“We are pleased to receive FDA Orphan Drug Designation for SER-287 and we look forward to advancing the program into further development for Ulcerative Colitis. Based on the highly encouraging Phase 1b clinical results and favorable safety profile, we intend to evaluate SER-287 in a pediatric UC population as part of our overall development plan. Safety is of particular importance to the pediatric population, and given the positive safety profile observed in our clinical trial to date, we believe our microbiome approach may be well suited to address this group,” said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres.

About SER-287

SER‐287 is a biologically sourced, oral formulation containing a consortium of live bacterial spores that is being developed for Ulcerative Colitis and other forms of inflammatory bowel disease. SER-287 is hypothesized to act through a novel mechanism of action by modulating the dysbiotic microbiome thereby reducing inflammation without immunosuppression effects. A healthy microbiome has been shown to maintain the integrity of the colonic barrier, reduce the signaling by pro-inflammatory molecules produced by certain bacteria, and induce regulatory T cells in the colon to modulate immune responses.1

About Ulcerative Colitis

Ulcerative Colitis is a serious chronic condition affecting approximately 700,000 individuals in the United States. The disease results in inflammation of the colon and rectum and can cause debilitating symptoms, including abdominal pain, bowel urgency, and diarrhea. Severe cases of Ulcerative Colitis may result in surgical removal of the colon.

About Seres Therapeutics

Seres Therapeutics, Inc., is a leading microbiome therapeutics platform company developing 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’ lead program, SER-109, has obtained Breakthrough Therapy and Orphan Drug designations from the U.S. Food and Drug Administration and is in Phase 3 development for multiply recurrent C. difficile infection. Seres’ clinical candidate SER-287 has successfully completed a Phase 1b study in patients with mild-to-moderate Ulcerative Colitis. Seres is also developing SER-262, the first ever synthetic microbiome therapeutic candidate, in a Phase 1b study in patients with primary C. difficile infection.