The stool bank will also continue providing fecal transplant preparations to clinicians and researchers
SOMERVILLE, Mass. – OpenBiome, a public stool bank, announced today that it has entered into a collaboration with Finch Therapeutics, a microbiome biopharmaceutical company, to enable FDA approval of a fecal transplant pill for the treatment of recurrent C. difficile infection. Finch will be licensing OpenBiome’s biomanufacturing quality systems and incorporating manufacturing upgrades as well as its own drug delivery technology to prepare the product for clinical trials and eventual marketing authorization.
Since delivering its first treatment in October 2013, OpenBiome has distributed more than 21,000 treatments to its network of over 800 hospitals and clinics. Fecal microbiota transplantation (FMT) is used to treat C. difficile infections that are not responsive to antibiotic therapies. C. difficile is the most common hospital-acquired infection in the country, affecting 453,000 patients a year, and resulting in an estimated 29,000 deaths. 1 in 5 patients do not respond to first-line antibiotics. For patients who fail multiple courses of antibiotic treatment, fecal transplantation has been shown to prevent recurrence in more than 85% of cases.
OpenBiome was founded to expand safe access to fecal transplantation for patients with recurrent C. difficile infection and to catalyze research on the role of the microbiome in human health. The stool bank provides clinicians with rigorously screened, ready-to-use stool microbiota preparations and supports researchers with a suite of tools to discover how gut bacteria might treat diseases beyond C. difficile. When it launched, patients in need of fecal transplants often had to travel significant distances for a visit to one of the few fecal transplant practitioners in the country. Today, more than 97% of the US population lives within a two-hour drive of a provider using OpenBiome material to perform FMT.
An interim policy from the U.S. Food and Drug Administration (FDA) allows physicians to perform FMT for the treatment of recurrent C. difficile infection, despite the fact that the therapy is not FDA-approved. Medical professional societies and clinical researchers advocated for the policy based on the available literature on FMT’s safety and efficacy and the lack of treatment alternatives for this patient population.
“To preserve patient access to this treatment option, and given the scale that we’ve reached, demonstrating the safety and efficacy of fecal transplantation through adequate and well-controlled clinical trials is the right thing to do,” explained Carolyn Edelstein, OpenBiome’s director of Outreach and Public Affairs, in an op-ed published earlier today with the Fecal Transplant Foundation.
OpenBiome will continue to supply clinicians and researchers with material, manufactured by Finch, under prevailing FDA policy and in support of its nonprofit mission to enable patient access and research. Under the terms of the collaboration, OpenBiome will license its quality system for biomanufacturing to Finch. Finch will incorporate its novel drug delivery technology to enable the targeted release of microbes at the site of the C. difficile infection in the colon. Finch will also upgrade the manufacturing system to support FDA approval, and will provide material produced in this improved quality environment to OpenBiome.
FIN-403 is the lead product candidate emerging from this partnership. Finch expects to begin enrolling for a Phase II clinical trial to evaluate the safety and efficacy of FIN-403 for the prevention of recurrence in recurrent C. difficile patients in the second half of 2017.
OpenBiome will receive a series of upfront payments, ongoing milestone payments, and royalties on sales of FIN-403 and other products developed in the collaboration. With these resources, OpenBiome will support early-stage, high-risk, long-term microbiome research programs that might not be able to secure traditional funding. With this additional funding for its independent research program, OpenBiome will work to advance public knowledge on how gut bacteria can be engineered to help cure or even prevent disease.
Dr. Mark Smith, PhD, OpenBiome’s co-founder and research director, will be stepping down from his roles at OpenBiome to serve as the CEO at Finch. He will maintain a seat on the OpenBiome Board of Directors and serve as an advisor to OpenBiome’s Scientific Review Board.
“This affiliation will allow us to execute our mission at a level we could not have imagined before,” said James Burgess, OpenBiome’s Executive Director, in a letter to OpenBiome’s clinicians and researchers. “Through it, we will provide safe access to fecal transplantation for patients with recurrent C. difficile today, and help Finch pursue FDA approval so that patients have this access in perpetuity. OpenBiome will continue to catalyze research in the microbiome by providing clinical investigators with logistical and material support, and by facilitating the kind of discoveries that will help cure or even prevent disease. We are thrilled by the path ahead.”
For more details on this announcement, please see:
“It’s time for FDA-approved poo” by Catherine Duff and Carolyn Edelstein
An open letter to the clinicians and researchers we serve
A memo on the collaboration’s process and framework
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. Its research portfolio includes 49% of all U.S. trials exploring the use of fecal transplants in new diseases.
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 patient outcomes, and develops therapies that that deliver those microbial communities to the patient. As Finch’s first clinical-stage program, FIN-403 provides both a short-term opportunity for impacting C. difficile and a long-term platform for designing new therapies.