All patients with mild-to-moderate ulcerative colitis (UC) have been enrolled in Seres Therapeutics‘ ongoing Phase 1b clinical study evaluating the company’s drug therapy candidate, SER-287.
The ongoing randomized, placebo-controlled, multiple-dose, Phase 1b study (NCT02618187) is evaluating SER-287 versus a placebo drug in 58 patients with mild-to-moderate UC, who are failing to respond to other therapies, at several clinical sites in the U.S.
The study is primarily intended to assess the safety and tolerability of SER-287. A co-primary objective of the study is to identify preliminary signs of efficacy of SER-287 as measured by changes in patients’ microbiome (microorganisms living in the gut) at up to eight weeks after dosing. Patients’ samples will be collected throughout the study to see the impact of SER-287 compared to placebo on the intestinal bacteria of patients.
“The completion of enrollment in our SER-287 Phase 1b study marks an important step towards our goal of developing a novel microbiome-based approach to treat ulcerative colitis, a serious disease where many patients are not well managed by currently available therapies,” Roger J. Pomerantz, MD, president, CEO and chairman of Seres, said in a recent press release. “We believe that SER-287 has the potential to offer ulcerative colitis patients a novel, non-immunosuppressive treatment option.”
The development of SER-287 for UC is supported by a growing body of evidence suggesting that the disease is characterized by an imbalance of bacteria in the gut, and that treating this imbalance may lead to a meaningful clinical impact. SER-287, rather than suppressing the immune system, may reduce the triggers of immune excessive activation.
SER-287 is one of Seres’ Ecobiotic drugs developed using the company’s proprietary microbiome therapeutics platform, which consists of combinations of selected microbes designed to restore a healthy microbiome in individuals with an unhealthy microbiota balance, which can lead to diseases such as inflammatory bowel disease (IBD), including UC.
SER-287 is the first microbiome therapeutic candidate to reach clinical-stage development in a chronic disease. According to Seres, preclinical studies with multiple animal models of UC showed the drug reduced disease pathology.
The first results from the Phase 1b study are expected in a few months.