Novel Candidates Based on Defined Bacterial Consortia

Gut dysbiosis is a known driver of inflammatory and infectious GI diseases, as well as a growing list of other immune and metabolic diseases. Multiple randomized, controlled clinical trials have demonstrated that restoration of the gut microbiota can have therapeutic benefit in GI diseases, including Inflammatory Bowel Disease (IBD) and recurrent C. difficile infection (rCDI). As a therapeutic approach, bacterial consortia—multiple bacterial species interacting with each other—can re-establish a healthy homeostasis in patients with diseases that are associated with a dysbiotic state, and perform complex physiological functions and correct imbalances that are not readily addressed by existing pharmaceutical modalities.

How Our Product Engine Works

Our product engine, consisting of our discovery platform and advanced manufacturing capabilities, has demonstrated its ability to rationally select defined bacterial consortia that go on to show clinical activity. Like traditional pharmaceuticals, our consortia are designed to have standardized compositions with consistent quality attributes that can be administered without risk of transferring pathogens and produced at large scale.

We generate our defined bacterial consortia candidates using a multi-step process, starting with human interventional FMT data to identify specific bacteria that correlate with clinical response, and investigating whether these observed signatures are causally linked to disease outcomes in vivo. To support the selection of specific strains for inclusion in our product candidates, we screen one of the world’s largest microbiome strain libraries, consisting of nearly 100,000 bacterial isolates, in proprietary assays to select strains with desired pharmacology. We then assemble and optimize customized consortia using computational tools, co-culture systems, and animal models, and manufacture CGMP-grade supplies of the resulting drug candidates using our in-house, state-of-the-art facilities.

Our proprietary product engine and targeted approach to harnessing the microbiome has enabled us to generate what we believe is the most advanced portfolio of defined bacterial consortia in the industry.