Policy & Regulation
Seres Therapeutics Reports Corporate Changes to Focus on Advancing Clinical Assets
8 February 2019 - - US-based microbiome therapeutics platform company Seres Therapeutics, Inc. (NASDAQ: MCRB) has made certain corporate changes to focus resources on its highest priority, clinical-stage microbiome therapeutic candidates, the company said.

The company said it will now concentrate on completing the recently-initiated SER-287 Phase 2b study in mild-to-moderate ulcerative colitis, obtaining results from the ongoing SER-109 Phase 3 study for recurrent C. difficile infection and advancing the SER-401 Phase 1b study, in collaboration with the Parker Institute for Cancer Immunotherapy and MD Anderson Cancer Center, to evaluate augmenting checkpoint inhibitor response in patients with metastatic melanoma.

Seres continues to enroll the SER-109 Phase 3 study for patients with recurrent C. difficile infection despite the widespread use of unapproved, fecal microbiota transplantation to treat C. difficile infection.

As interference from this uncontrolled procedure has impacted the enrollment rate of the company's placebo-controlled clinical trial, Seres is evaluating modification of the study design to expedite clinical results.

The company will continue to pursue focused preclinical activity on SER-301, a rationally designed microbiome therapeutic candidate for ulcerative colitis, leveraging learnings obtained from the company's prior clinical study results.

The company will make changes to its executive team and reduce its full-time workforce by approximately 30 employees, and additional contractors, that in total represent approximately 30% of the workforce.

The positions eliminated are primarily related to research, manufacturing, and general and administrative services.

David Cook, Ph.D., executive vice president and chief scientific officer, will transition from his current role with the company and will continue to provide consulting services to Seres with a specific focus on immuno-oncology.

Matthew Henn, Ph.D., previously executive vice president and Head of Discovery and Microbiome R and D, has been appointed chief scientific officer.

Dr. Henn joined Seres in 2012 and has contributed to the discovery and development of Seres' microbiome therapeutic candidates.

Prior to joining the company, Dr. Henn served as the director of Viral Genomics and Assistant director of the Genome Sequencing Center for Infectious Diseases at the Broad Institute of MIT and Harvard University.

The company plans to provide updated operating financial guidance in conjunction with its upcoming fourth quarter and full year 2018 financial results and business update scheduled for March 6, 2019.

Seres Therapeutics is developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the state of bacterial diversity and function is imbalanced.

The company's most advanced programme, SER-109, has obtained Breakthrough Therapy and Orphan Drug designations from the US Food and Drug Administration and is in Phase 3 development for recurrent C. difficile infection.

SER-287 is being evaluated in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis. Seres is also advancing SER-401 into clinical development to augment the efficacy of current immuno-oncology treatments.