Seres Therapeutics has dosed the first patient in a phase 1b clinical trial, which is assessing SER-301 for the treatment of active mild-to-moderate ulcerative colitis (UC).
According to the US-based biotech company, SER-301 is an oral fermented microbiome therapeutic designed for dampening the unusual gastrointestinal inflammation central to ulcerative colitis and promote clinical remission in patients with active ulcerative colitis.
SER-301 is expected to alter the gastrointestinal microbiome and microbe-associated metabolites to control multiple pathways related to the inflammatory bowel disease.
The investigational microbiome therapeutic is a group of bacteria designed by using the reverse translational discovery platform of Seres Therapeutics that integrates analysis of microbiome biomarkers from human clinical data and also preclinical assessments using human cell-based assays and in vitro and in vivo disease models.
Matthew Henn – Executive Vice President and Chief Scientific Officer of Seres Therapeutics said: “Ulcerative colitis is a serious disease impacting approximately 700,000 individuals in the U.S. alone, and effective patient management can be challenging. Currently approved treatments are unable to induce disease remission in the large majority of patients, and many existing drugs are associated with a suboptimal safety profile.
“We believe that microbiome therapeutic approaches have the opportunity to address this condition in an entirely novel way which targets the underlying drivers of disease by modulating multiple disease-relevant pathways simultaneously, and with a favorable safety profile.”
The SER-301 phase 1b clinical study is being held in Australia and New Zealand featuring nearly 65 patients who are divided across two cohorts. A first open-label cohort consisting of 15 patients will assess safety and pharmacokinetics, as measured by bacterial engraftment.
In the second cohort, 50 patients will be randomly grouped to be administered either SER-301 or placebo, with a 3:2 randomization, respectively. The goals for this second cohort are to assess safety and pharmacokinetics, clinical remission, and other measures of drug pharmacology and efficacy as secondary endpoints.
Seres Therapeutics will be eligible to get a milestone payment of $10 million related to the initiation of the clinical trial from Nestlé Health Science, which is its ex-North American collaborative partner for the investigational microbiome therapeutic.