2017

OpenBiome welcomes new Executive Director

PressReleaseHires.png

SOMERVILLE, Mass. – The Board of Directors of OpenBiome announced today that with unanimous and enthusiastic support, they have named Carolyn Edelstein, MPA, as OpenBiome’s new Executive Director, effective today.

carolyn edelstein.jpg

Edelstein will succeed James Burgess, who will remain on the Board of Directors. He will be transitioning to VP of Innovation at Finch Therapeutics after serving as founding Executive Director since OpenBiome’s launch in 2012.

“Carolyn has been deeply involved in every aspect of our growth since our start,” said Burgess, “Her energy, skill, and wisdom have shaped everything from our patient-centered approach, to our groundbreaking research collaborations, to our partnership with the FDA. I couldn’t be more excited to see where she leads OpenBiome next.”

As one of the founding members of OpenBiome, Edelstein has been guiding the development, mission, and values of the organization since its inception. Her efforts as Director of Outreach and Public Affairs shaped OpenBiome’s public presence and brought awareness of and access to life-saving FMT to patients, doctors, and researchers around the world.

“We are incredibly fortunate to have Carolyn at the helm of OpenBiome as we enter our sixth year,” said Jim Burnham, Chairman of the Board of Directors, “Her dedication to our mission and her inspiring vision for the future will keep OpenBiome at the forefront of patient treatment and cutting-edge research into the microbiome.

Edelstein’s work on FMT access and regulation has appeared in Nature Biotechnology, the Journal of Law and the Biosciences, and Clinical Research and Regulatory Affairs. She has overseen OpenBiome’s coverage in major national and international media outlets, including The New York Times, CNN, NPR, BBC, AP and many others.

Previously, she worked at the U.S. Agency for International Development, where she helped launch the Global Innovation Fund, a $200 million institution backed by foreign aid agencies from the U.S., U.K., Canada, Australia, Sweden, and South Africa to test and support low-cost, high-impact interventions to improve global health and prosperity. She holds an MPA and a BA from Princeton University's Woodrow Wilson School of Public and International Affairs, where she was awarded the Scholars in the Nation's Service Initiative (SINSI) Fellowship, a four-year program to support outstanding individuals to launch careers in public service.

 

About OpenBiome
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 900 healthcare institutions across all 50 states and 7 countries to deliver nearly 30,000 treatments for recurrent C. difficile. Its research portfolio includes 49% of all U.S. trials exploring the use of fecal transplants to treat disease.

Contact: media@openbiome.org
Download this press release (98KB).

OpenBiome presented data on donor efficacy factors and pediatric access at DDW

The nonprofit stool bank shared data from a 1,413 patient cohort of fecal transplant recipients and research from 14 abstracts at Digestive Disease Week.

PressReleaseResearch.png

SOMERVILLE, Mass — OpenBiome, a public stool bank, presented new research on fecal microbiota transplantation (FMT) at the 2017 Digestive Disease Week (DDW) meeting in Chicago. Among the five abstracts accepted were studies on whether specific bacteria in FMT drive clinical cure of recurrent Clostridium difficile infection (CDI), the effects of stool donor diet on clinical outcomes, stool processing time and FMT quality, and pediatric access to FMT. OpenBiome also coauthored an additional 9 abstracts presented at the meeting.

One of OpenBiome’s studies won a DDW award for an outstanding poster. Shrish Budree, MD, Clinical Research Fellow at OpenBiome, and Pratik Panchal, MD, MPH, won recognition for “Pediatric Access to Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection in the United States and the Impact of Stool Banks: A Geospatial Analysis.” According to this study by Budree et al., pediatric Clostridium difficile patients have much less access to FMT than the adult population. Budree and his colleagues found that 72.4% of the U.S. population lives within a 4-hour drive of a pediatric FMT provider, and just 49.4% of the population lives within a 2- hour drive of a pediatric FMT provider. By contrast, previous research has shown that 99.7% of adult patients live within a 4-hour drive of an FMT facility, and 96.7% have an FMT provider within a 2-hour drive.

Dr. Budree also presented findings on several factors that theoretically could affect donor stool FMT efficacy for recurrent CDI: donor metabolomics, diet, stool consistency, and laboratory processing time. Budree and his team collected complete clinical, microbial and metabolomics data for fecal material from 59 donors whose material was used across 1,413 patients with CDI (mean clinical cure rate 84.9%).

Budree et al.’s study of stool pathology and donor nutrition (long-term intake of fiber, fat, calories, and carbohydrates) found that these factors did not significantly change patient outcomes. Another Budree et al. study showed that for stool with a Bristol Stool Scale score of 3-5, donor stool consistency is not associated with clinical cure rates among patients treated with FMT for CDI. Budree et al. found no statistically significant factors driving differences in observed patient outcomes in these studies. These findings suggest that other variables such as patient-specific factors may be causing differences in cure rates for FMT in recurrent CDI.

A final abstract by Budree et al. showed no difference in microbial abundance in stool processed within 30 min or 180 minutes after passage, suggesting that longer stool processing times do not promote pathological microbial bloom, and would not affect FMT effectiveness for CDI.

DDW was held May 5-7 in Chicago, IL. More information about OpenBiome, including its mission, patient stories, and Quality & Safety Assurance program, is available at www.openbiome.org.

Full list of OpenBiome and OpenBiome affiliate posters, DDW 2017

  • Do specific bacteria drive clinical cure in fecal microbiota transplantation for Clostridium difficile infection? Clinical, microbial and metabolomic characterization of universal FMT donors (Budree et al.)[view]

  • The association of donor stool consistency by Bristol stool scale on microbial profile and clinical outcomes of fecal microbiota transplantation in Clostridium difficile infection (Budree et al.)[view]

  • The association of stool donor diet on microbial profile and clinical outcomes of fecal microbiota transplantation in clostridium difficile infection (Budree et al.) [view]

  • Donor stool processing time: the effect on the intestinal microbiome and clinical outcomes of fecal microbiota transplantation in Clostridium difficile Infection Budree et al.)[view]

  • Pediatric access to fecal microbiota transplantation for recurrent Clostridium difficile Infection in the United States and the impact of stool banks: a geospatial analysis (Panchal et al.)[view]

  • Fecal microbiota transplant using a precision medicine approach is safe, associated with lower hospitalization risk and improved cognitive function in recurrent hepatic encephalopathy. (Bajaj et al.) [view]

  • Prevalence of early antibiotic use post-fecal microbiota transplantation and corresponding risk of FMT failure. (Allegretti et al.)[view]

  • Does Rifaximin prior to fecal microbiota transplantation improve clinical outcomes compared to microbiome restoration alone in ulcerative colitis? A cohort study evaluating the impact of non-absorbable antibiotic pretreatment. (El-Nachef et al.) [view]

  • Fecal microbiota transplantation is safe and effective in chronic pouchitis patients (El-Nachef et al.) [view]

  • The role of fecal microbiota transplantation in ulcerative colitis and Crohn’s disease: results from a parallel inflammatory bowel disease cohort study (El-Nachef et al.) [view]

  • Does fecal microbiota transplantation from an obese donor lead to weight gain? A case series of 70 recipients (Fischer et al.) [view]

  • Fecal microbiota transplantation is safe and effective for the treatment of Clostridium difficile infection in solid organ transplant recipients (Fischer et al.) [view]

  • Should we recommend anti-Clostridium difficile antibiotic or probiotic prophylaxis? Risk of Clostridium difficile infection with systemic antimicrobial therapy following successful fecal microbiota transplant. (Fischer et al.) [view]

  • Fecal microbiota transplantation differentially influences the gut microbiota of Clostridium difficile infection and ileal pouch anal anastomosis patients. (Piceno et al.) [view]

 

 

 

OpenBiome partnering with Finch Therapeutics to enable FDA approval of a fecal transplant treatment for recurrent C. difficile infection

The stool bank will also continue providing fecal transplant preparations to clinicians and researchers

PressReleaseResearch.png

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:

About OpenBiome
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.

About Finch
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.

Contact: media@openbiome.org

OpenBiome celebrates 20,000th treatment for recurrent C. difficile infection

PressReleaseMilestoneV2.png

SOMERVILLE, Mass - OpenBiome, the first public stool bank, celebrated shipping its 20,000th fecal microbiota transplantation (FMT) preparation today for use in treating deadly Clostridium difficile (C. diff) infections. “We’re proud to have helped hundreds of clinicians help patients with recurrent C. diff infections, and we look forward to working with even more partners in 2017,” said James Burgess, OpenBiome’s executive director. “With more than 800 providers in 50 states, it’s clear that the medical community has taken ownership of this treatment.”

OpenBiome’s shipments increased from 7,141 treatments in 2015 to 10,997 FMT in 2016, including oral capsules and upper and lower GI formats. OpenBiome is projected to provide 30,000 treatments by November 2017.

OpenBiome’s shipments increased from 7,141 treatments in 2015 to 10,997 FMT in 2016, including oral capsules and upper and lower GI formats. OpenBiome is projected to provide 30,000 treatments by November 2017.

In the four years since OpenBiome provided its first treatment, it has grown to support hospitals and clinics with more than 1,000 FMT preparations per month. More than 453,000 Americans contract C. diff infections each year, and 29,000 die. When antibiotics fail to cure patients after multiple attempts, FMT has been found to cure 85% of antibiotic-resistant C. diff infections.

Thanks to a growing network of providers, 97% of Americans live within a two-hour drive of a treatment center offering FMT. OpenBiome also supplies material for 47% of the open clinical trials of FMT in the United States, supporting research on the therapy’s potential for treating conditions including ulcerative colitis, Crohn’s disease, and irritable bowel syndrome.

“This field is expanding rapidly,” said Mark Smith, OpenBiome’s research director. “What was a fringe treatment just five years ago is now standard, and we’re just beginning to explore how human health can be advanced through microbiome-based interventions. It’s exciting to be part of this research.”

For patients who have suffered with C. diff, the impact of a successful FMT can be profound. As one patient wrote, “I am 51 today. I was 42 years old when I was first diagnosed with cancer and when the diarrhea began. I have a lot of living yet to do, living a life that I had thought was nearly over, and is now just beginning again. My life is beginning again because I had the opportunity to have a fecal transplant from a stranger who came to my aid.”

OpenBiome is a nonprofit stool bank and research platform founded in 2012 to expand safe access to FMT and to catalyze research. For more information about FMT treatment, providers, and research, visit www.openbiome.org.