First Clinical Study of an Ecobiotic® Microbiome Therapeutic in a Chronic, Non-infectious Disease
CAMBRIDGE, MA, USA I December 14, 2015 I Seres Therapeutics Inc. (NASDAQ:MCRB), a leading microbiome therapeutics company, announced today that it has initiated a Phase 1b clinical trial evaluating SER-287 in mild-to-moderate ulcerative colitis (UC). The program IND has been cleared by the FDA, and clinical investigational sites are now open and actively enrolling patients. SER-287 is the first microbiome therapeutic candidate to reach clinical-stage development in a chronic disease, and the first in an indication outside of infectious disease.
“We are pleased to initiate this trial and advance our second microbiome therapeutic candidate into the clinic. The development of SER-287 is supported by a growing body of evidence suggesting that UC is marked by an imbalance of bacteria (dysbiosis) in the gut, and that treating that dysbiosis may lead to a meaningful clinical impact. SER-287 potentially represents a novel and unique method to treat UC, and we are excited to evaluate how SER-287 could be a significant development for patients in need of more effective, non-immunosuppressive treatments for this very difficult condition,” said Roger Pomerantz, M.D., President, Chief Executive Officer and Chairman of Seres.
The randomized, placebo-controlled multiple dose Phase 1b study of SER-287 is expected to enroll up to 55 subjects with active mild-to-moderate UC who are failing current therapies. The primary endpoint of the study will evaluate the change in the microbiome resulting from SER-287 treatment. The study will also evaluate clinical response, mucosal healing, as well as metabolomic, immunological and safety findings. The study is being conducted in the United States.
The clinical development of SER-287 to treat UC is supported by preclinical studies in multiple animal models of colitis that provide evidence that SER-287 administration results in reduced pathology. Recently published clinical reports furthermore suggest that modulation of the microbiome through repetitive fecal microbiota transplants may lead to meaningful clinical response in certain UC patients.
SER-287 is an oral capsule developed using Seres’ proprietary microbiome therapeutics platform. It is a biologically sourced therapeutic candidate comprised of a complex and diverse bacterial spore ecology. In addition to SER-287, Seres’ development pipeline includes SER-301, a rationally designed, synthetic product comprised of in vitro cultured bacterial species for development in UC and other chronic gastrointestinal disorders with high unmet medical need.
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 characterized by an increased presence of pathogenic bacterial species, where the natural state of bacterial diversity is imbalanced. Seres’ most advanced program, SER-109, has successfully completed a Phase 1b/2 study demonstrating a clinical benefit in patients with recurring Clostridium difficile infection (CDI). A Phase 2 study evaluating SER-109 in recurring CDI is ongoing, with results expected in mid-2016.
About Ulcerative Colitis
Ulcerative colitis (UC) 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 result in debilitating symptoms, including abdominal pain, bowel urgency and diarrhea.
SOURCE: Seres Therapeutics
Post Views: 336
First Clinical Study of an Ecobiotic® Microbiome Therapeutic in a Chronic, Non-infectious Disease
CAMBRIDGE, MA, USA I December 14, 2015 I Seres Therapeutics Inc. (NASDAQ:MCRB), a leading microbiome therapeutics company, announced today that it has initiated a Phase 1b clinical trial evaluating SER-287 in mild-to-moderate ulcerative colitis (UC). The program IND has been cleared by the FDA, and clinical investigational sites are now open and actively enrolling patients. SER-287 is the first microbiome therapeutic candidate to reach clinical-stage development in a chronic disease, and the first in an indication outside of infectious disease.
“We are pleased to initiate this trial and advance our second microbiome therapeutic candidate into the clinic. The development of SER-287 is supported by a growing body of evidence suggesting that UC is marked by an imbalance of bacteria (dysbiosis) in the gut, and that treating that dysbiosis may lead to a meaningful clinical impact. SER-287 potentially represents a novel and unique method to treat UC, and we are excited to evaluate how SER-287 could be a significant development for patients in need of more effective, non-immunosuppressive treatments for this very difficult condition,” said Roger Pomerantz, M.D., President, Chief Executive Officer and Chairman of Seres.
The randomized, placebo-controlled multiple dose Phase 1b study of SER-287 is expected to enroll up to 55 subjects with active mild-to-moderate UC who are failing current therapies. The primary endpoint of the study will evaluate the change in the microbiome resulting from SER-287 treatment. The study will also evaluate clinical response, mucosal healing, as well as metabolomic, immunological and safety findings. The study is being conducted in the United States.
The clinical development of SER-287 to treat UC is supported by preclinical studies in multiple animal models of colitis that provide evidence that SER-287 administration results in reduced pathology. Recently published clinical reports furthermore suggest that modulation of the microbiome through repetitive fecal microbiota transplants may lead to meaningful clinical response in certain UC patients.
SER-287 is an oral capsule developed using Seres’ proprietary microbiome therapeutics platform. It is a biologically sourced therapeutic candidate comprised of a complex and diverse bacterial spore ecology. In addition to SER-287, Seres’ development pipeline includes SER-301, a rationally designed, synthetic product comprised of in vitro cultured bacterial species for development in UC and other chronic gastrointestinal disorders with high unmet medical need.
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 characterized by an increased presence of pathogenic bacterial species, where the natural state of bacterial diversity is imbalanced. Seres’ most advanced program, SER-109, has successfully completed a Phase 1b/2 study demonstrating a clinical benefit in patients with recurring Clostridium difficile infection (CDI). A Phase 2 study evaluating SER-109 in recurring CDI is ongoing, with results expected in mid-2016.
About Ulcerative Colitis
Ulcerative colitis (UC) 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 result in debilitating symptoms, including abdominal pain, bowel urgency and diarrhea.
SOURCE: Seres Therapeutics
Post Views: 336
