CAMBRIDGE, Mass.--(BUSINESS WIRE)--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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the clinical benefit of SER-287, dysbiosis of the microbiome as an underlying cause of ulcerative colitis, the efficacy of treating the microbiome to treat ulcerative colitis, the enrollment of the Phase 1b clinical study for SER-287 and the timing of clinical study results.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding, which may not be available; our limited operating history; the unpredictable nature of our early stage development efforts for marketable drugs; the unproven approach to therapeutic intervention of our microbiome therapeutics; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; potential delays in enrollment of patients which could affect the receipt of necessary regulatory approvals; potential delays in regulatory approval, which would impact the ability to commercialize our product candidates and affect our ability to generate revenue; any fast track or Breakthrough Therapy designation may not lead to faster development, regulatory approval or marketing approval; our possible inability to receive orphan drug designation should we choose to seek it; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; our lack of experience in manufacturing our product candidates; the potential failure of our product candidates to be accepted on the market by the medical community; our lack of experience selling, marketing and distributing products and our lack of internal capability to do so; failure to compete successfully against other drug companies; potential competition from biosimilars; failure to obtain marketing approval internationally; post-marketing restrictions or withdrawal from the market; anti-kickback, fraud, abuse, and other healthcare laws and regulations exposing us to potential criminal sanctions; recently enacted or future legislation; compliance with environmental, health, and safety laws and regulations; protection of our proprietary technology; protection of the confidentiality of our trade secrets; changes in United States patent law; potential lawsuits for infringement of third-party intellectual property; our patents being found invalid or unenforceable; compliance with patent regulations; claims challenging the inventorship or ownership of our patents and other intellectual property; claims asserting that we or our employees misappropriated a third-party’s intellectual property or otherwise claiming ownership of what we regard as our intellectual property; adequate protection of our trademarks; ability to attract and retain key executives; managing our growth could result in difficulties; risks associated with international operations; potential system failures; the price of our common stock may fluctuate substantially; our executive officers, directors, and principal stockholders have the ability to control all matters submitted to the stockholders; a significant portion of our total outstanding shares are eligible to be sold into the market in the near future; unfavorable or lacking analyst research or reports; and we may be subject to securities class action litigation. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 12, 2015 and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.