Finch Therapeutics has raised $53 million to take its microbiome treatment for recurrent Clostridium difficile infections through to a potentially pivotal readout.
Massachusetts-based Finch established itself in the nascent microbiome field in 2017 when it emerged with a license for the manufacturing quality system from public stool bank OpenBiome and quickly added a clinical-phase drug designed to prevent recurrent C. difficile infections through a merger with Crestovo. That clinical asset, CP101, is now heading toward a potentially pivotal readout.
Typically, the FDA may be unlikely to approve a C. difficile candidate on the strength of results from a single, 200-subject clinical trial. But, based on its talks with the agency, Finch thinks it has a shot if the study generates “compelling results.”
Seres Therapeutics, a rival in the C. difficile microbiome space, received similar FDA feedback ahead of the start of its ongoing trial of SER-109, which the agency may treat as pivotal if it demonstrates a “persuasive clinical effect.” Seres’ efforts to generate such persuasive data have been undermined by slow recruitment, which led the company to cut its enrollment target and push back the readout.
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Finch has also delayed and shrunk its potentially pivotal trial. The original trial plan called for Finch to enroll 240 subjects and set the study completion target at May 2019. Today, the plan is to enroll 200 subjects and complete the study in June 2020.
Talking to investors earlier this month, Seres Chief Medical Officer Kevin Horgan pinned the slow enrollment in his company’s trial on “widespread continued use of [fecal microbiota transplantation] to treat C. diff infection.” Seres and Finch both hope to supercede FMT, an experimental approach, by bringing oral, clinically validated alternatives to market but are competing against the approach for trial subjects.
Finch will use some of the series C funds to keep pushing CP101 through the potentially pivotal trial. The rest of the money will go toward earlier-stage programs, the most advanced of which is testing the full-spectrum microbiota drug from the C. difficile trial in people with autism spectrum disorder.
Back in preclinical, Finch has a rationally selected microbiota asset it is developing in inflammatory bowel disease in partnership with Takeda. Finch teamed up with Takeda in 2017.
The series C round featured new investors including OCV Partners, Susquehanna International Group, Symbiosis and the Trans-Pacific Technology Fund plus a clutch of backers from earlier VC rounds.
Date: August 27, 2019
Source: FierceBiotech
