SER-109 is under clinical development by Seres Therapeutics and currently in Pre-Registration for Clostridioides difficile Infections (Clostridium difficile Associated Disease). According to GlobalData, Pre-Registration drugs for Clostridioides difficile Infections (Clostridium difficile Associated Disease) have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how SER-109’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

SER-109 overview

SER-109 is under development for the prevention of recurrent Clostridium difficile infections. The therapeutic candidate is administered orally. It is a multifunctional consortia comprising of purified eubacterial spores, that are encapsulated. The therapeutic candidate is developed based on human microbiome therapeutics technology.

Seres Therapeutics overview

Seres Therapeutics (Seres) is a microbiome therapeutics platform company that develops a novel class of biological drugs. The company creates a new class of medicines to treat diseases resulting from functional deficiencies in the microbiome, a condition known as dysbiosis. The company’s lead development candidate, SER-109 is an oral microbiome therapeutic and bacterial spore ecology. Seres’ SER-287 is an oral therapy for the treatment of ulcerative colitis, an inflammatory bowel disease. Its development programs also include SER-301 and SER-155, which are investigational, oral, rationally designed, fermented microbiome therapeutic. The company utilizes its microbiome therapeutics platform to identify key alterations in the microbiome that are associated with or lead to specific diseases. Seres is headquartered in Cambridge, Massachusetts, the US

For a complete picture of SER-109’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.