Seres Therapeutics’ proprietary discovery and design platform enables us to identify key alterations in the microbiome that are associated with or lead to specific diseases, and to rationally design tailored therapies that disrupt the disease state and establish a healthy microbiome.
Our lead development candidate, SER-109, is an investigational oral microbiome therapeutic for the prevention of Clostridium difficile infection (CDI) in adults with multiply recurrent CDI. The FDA has designated SER-109 as a Breakthrough Therapy and an Orphan Drug.
Seres plans to initiate a new SER-109 Phase 2 clinical study (ECOSPOR III) in patients with multiply recurrent C. difficile infection. The ECOSPOR III study design was finalized following a positive Type B meeting with the FDA. The FDA has agreed that this new trial may qualify as a pivotal study with achievement of a persuasive clinical effect and addressing FDA requirements, including clinical and statistical factors, an adequately sized safety database, and certain CMC parameters.
We are currently evaluating SER-262, the first synthetically-derived and designed microbiome therapeutic ever to reach clinical-stage development, in a Phase 1b study in patients with primary Clostridium difficile infection.
We are developing Ecobiotic® drugs to treat inflammatory bowel disease, including ulcerative colitis (UC). Our clinical candidate SER-287 is being evaluated in a Phase 1b study in patients with UC.
In addition, we are also researching the use of Ecobiotic® drugs for the treatment of additional inflammatory diseases and metabolic diseases.