Seres Therapeutics begins Phase 1b trial for SER-301 in active ulcerative colitis

Seres Therapeutics, a prominent US-based biotech company, has announced the commencement of dosing in a Phase 1b clinical trial for SER-301, a novel microbiome-based therapeutic designed to treat active mild-to-moderate ulcerative colitis (UC). This milestone marks an important step in the development of SER-301, which aims to provide a new treatment option for patients battling this chronic and often debilitating gastrointestinal condition.

What Is SER-301 and How Does It Work?

SER-301 is an oral microbiome therapeutic that targets the complex and abnormal gastrointestinal inflammation that characterizes ulcerative colitis. UC is an inflammatory bowel disease (IBD) that affects the colon and rectum, causing symptoms such as abdominal pain, diarrhea, and severe fatigue. Current treatment options for UC often fail to induce long-term remission for many patients and come with significant safety concerns.

The investigational therapy works by modulating the gastrointestinal microbiome—the community of microorganisms living in the digestive tract. The aim of SER-301 is to alter both the microbiome and the associated metabolites to regulate several pathways involved in the inflammatory process of ulcerative colitis. This could potentially address the root causes of the disease and promote clinical remission for patients suffering from active UC.

The Role of Seres Therapeutics’ Reverse Translational Discovery Platform

Seres Therapeutics has developed SER-301 using its proprietary reverse translational discovery platform. This platform integrates microbiome biomarker analysis from human clinical data with preclinical studies. It also employs human cell-based assays, as well as in vitro and in vivo disease models to identify the most promising microbiome-based interventions. The approach aims to target the underlying drivers of ulcerative colitis by utilizing a complex group of bacteria with therapeutic properties.

According to Matthew Henn, Executive Vice President and Chief Scientific Officer of Seres Therapeutics, the company’s approach holds considerable promise. He emphasized that “ulcerative colitis is a serious disease impacting approximately 700,000 individuals in the U.S. alone, and effective patient management can be challenging.” Henn also noted that many of the current treatments for UC fail to induce remission and often come with less-than-optimal safety profiles. He added that “microbiome therapeutic approaches have the opportunity to address this condition in an entirely novel way, targeting multiple disease-relevant pathways simultaneously, while maintaining a favorable safety profile.”

The Design of the Phase 1b Clinical Trial

The Phase 1b clinical trial for SER-301 is being conducted in Australia and New Zealand, enrolling approximately 65 patients diagnosed with active mild-to-moderate ulcerative colitis. The trial is divided into two cohorts to assess the safety, pharmacokinetics, and efficacy of the drug.

The first cohort includes 15 patients in an open-label group. This cohort is designed to evaluate the safety and pharmacokinetics of SER-301, with a particular focus on bacterial engraftment. In the second cohort, 50 patients will be randomly assigned to receive either SER-301 or a placebo in a 3:2 randomization ratio. The goals for this cohort include assessing the safety and pharmacokinetics of the drug, as well as evaluating clinical remission and other pharmacological endpoints, which will serve as secondary measures of efficacy.

Financial Implications and Partnerships

Seres Therapeutics’ ongoing research and development efforts are supported by strategic partnerships, including one with Nestlé Health Science. This partnership focuses on the commercialization of SER-301 outside of North America. As part of the agreement, Seres Therapeutics stands to receive a $10 million milestone payment following the initiation of the Phase 1b trial, further validating the progress of SER-301 and the potential for microbiome therapeutics in treating complex conditions like ulcerative colitis.

The Future of Microbiome Therapeutics in Treating Ulcerative Colitis

The success of SER-301 could pave the way for a new class of treatments targeting the microbiome to treat IBDs like ulcerative colitis. Microbiome therapeutics represent a promising frontier in medical research, with potential to address not only gastrointestinal disorders but also other conditions influenced by microbial imbalances, such as metabolic diseases, autoimmune disorders, and even neurological conditions.

If successful, SER-301 could offer hope to the many patients struggling with active UC who have not found relief from traditional treatments. As the trial progresses, the scientific and medical communities will be watching closely for further developments in this promising area of biopharmaceutical research.