SOMERVILLE, Mass.--(BUSINESS WIRE)--Finch Therapeutics, Inc., a microbiome therapeutics company, and OpenBiome, a leading public stool bank, today announced a collaboration to develop FIN-403, an orally administered microbial therapy for approval by U.S. Food and Drug Administration (FDA) in recurrent C. difficile infections.
“OpenBiome has transformed the standard of care for C. difficile through its best-in-class quality system for fecal microbiota transplantation,” commented Andrew Noh, the Chief Operating Officer of Finch Therapeutics. “We hope to change the field again with FIN-403, Finch’s orally administered microbial therapy that builds on this experience and delivers a broad spectrum of intestinal microflora to the site of infection in the colon. Developing FIN-403 from a biomanufacturing system and drug substance that has already been used in more than 21,000 treatments provides an unprecedented level of clinical experience and gives us enormous confidence in the underlying technology.”
Under the terms of the collaboration, OpenBiome will license its biomanufacturing quality system to Finch. Finch will upgrade this manufacturing system, and will provide microbiota preparations produced in this improved quality environment to OpenBiome. OpenBiome will continue to supply clinicians and researchers with material in support of its nonprofit mission to expand safe access to fecal transplantation and catalyze research on the human microbiome. OpenBiome will also receive upfront payment, milestone payments, and royalties on sales of FIN-403 and other products developed through the collaboration to further support its mission to enable patient care and research.
Finch Therapeutics announces dose-finding results for lead FIN-403 program
FIN-403 is an encapsulated, orally administered, whole-community microbiota therapy for recurrent C. difficile infections. FIN-403 incorporates Finch’s proprietary Aquashell formulation and Phloral, a dual-acting, targeted release technology licensed to Finch by Intract Pharma. Together, these technologies enable the oral administration and targeted release of a broad spectrum of healthy gut microflora. Finch will be launching a Phase 2 placebo-controlled study of FIN-403 in the second half of 2017.
Dose-finding work with FIN-403 has yielded promising clinical results and shown robust microbial engraftment, a key pharmacokinetic measure. In two doses across a total of 26 patients, FIN-403 demonstrated 88% per-protocol efficacy. Finch also used high-throughput DNA sequencing technology to demonstrate that the full diversity of the healthy microflora contained in FIN-403 successfully and stably engrafted in these patients.
This broad-spectrum engraftment profile is critical to the Company’s strategy for human-first discovery, in which Finch uses its proprietary machine-learning platform to identify the specific microbes that drive efficacy in microbiota transplantations. Finch is using this technique to develop a new generation of cultured microbial therapies.
Finch Therapeutics Secures $5.6 Million in Series A Financing
The Company also announced that it raised $5.6 million in Series A financing in 2016. The round was led by Flight Partners Management LLC, an investment company controlled by Jeff Smisek, former United Airlines CEO, and was joined by the Anna Maria and Stephen Kellen Foundation, the Draper Richards Kaplan Foundation, and Neil and Anna Rasmussen. Mr. Smisek has also joined Finch’s Board of Directors. The Series A funding is supporting the development of FIN-403 as well as Finch’s broader human-first discovery platform. Finch plans to complete a larger Series B financing later this year to support the initiation of its Phase 2 clinical trial with FIN-403 and to launch several additional therapeutic programs.
Finch Therapeutics is a mission-driven biopharmaceutical company that aims to develop novel microbial therapies serving patients with serious and unmet medical needs. Founded by data scientists, clinicians, and microbiologists from MIT and OpenBiome, Finch uses machine-learning algorithms informed by high-throughput molecular data to reverse engineer successful experiences with fecal transplantation. Through this and other clinical datasets, Finch identifies the microbes that drive desirable clinical outcomes, and develops therapies that deliver those microbial communities to patients. FIN-403 is both Finch’s lead clinical program and a valuable tool for its broader human-first discovery strategy.
OpenBiome is the first public stool bank, founded to expand safe access to fecal transplantation for patients with recurrent C. difficile infection and to catalyze research on the microbiome’s role in human health. OpenBiome provides clinicians with rigorously screened, ready-to-use stool preparations and supports researchers with a suite of tools to discover how gut bacteria might treat diseases beyond C. difficile. Since 2013, OpenBiome has partnered with over 800 healthcare institutions across all 50 states and 6 countries to deliver more than 21,000 treatments for recurrent C. difficile infections.