2015

OpenBiome co-hosts translational microbiome workshop at MIT

Nonprofit stool bank hosts workshop with researchers from the MIT Center for Microbiome Informatics & Therapeutics

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MEDFORD, Mass – Researchers from OpenBiome, the first public stool bank, and the MIT Center for Microbiome Informatics and Therapeutics brought together over 60 members of Boston’s clinical research community to discuss the current state of translational microbiome research.

As the name suggests, translational research aims to apply insights from basic science to improve clinical care and patient outcomes, closing the gap from research “bench-to-bedside.” During the workshop, physicians, scientists, students and public health advocates shared their current research projects and brainstormed solutions to problems facing translational research in this space.

The workshop was held the Broad Institute at MIT, commencing with a keynote address from Dr. Alan Moss, a leading researcher and gastroenterologist from Beth Israel Medical Center, whose work focuses on finding new applications of fecal microbiota transplantation for inflammatory bowel diseases. He spoke about the importance of designing effective clinical trials that measure objective end points and consider long-term follow up.

OpenBiome and MIT researchers organized this workshop to bring together the microbiome research community in Boston. Participants engaged in interactive group discussions, addressing topics such as “Law & the Microbiome” and “Microbiome Discoveries.” They also formed small groups to discuss challenges facing translational research and shared the outcomes of their brainstorming sessions with the larger audience. One group, tasked with the question of how to find donors for FMT in other indications, came up with a two step solution: First, “find donors that work and [then] study the heck out of them.”

Other presentations included Elaine Vo, PhD, who discussed OpenBiome’s capabilities for providing cutting-edge research tools, including the new FMT Capsule G3, a fecal transplant pill that offers the first non-invasive delivery method for C. difficile patients. Other key presenters included Eric Alm PhD, an Associate Professor of Biological Engineering at MIT, and Mark Smith PhD, co-founder and Research Director of OpenBiome.

“We were thrilled to bring together some of the field’s leading researchers for a day of educational discussions and collaboration,” said Dr. Mark Smith, PhD, Research Director at OpenBiome. “Translational microbiome research is poised to unlock unprecedented therapies and diagnostics to help patients with a range of diseases. By bringing together the best minds in this space, we hope to work together to make these possibilities reality.”

To learn more details about the day’s presentations and discussions, please contact the workshop’s coordinator Lindsay Eysenbach at lindsay@openbiome.org


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OpenBiome Presents at ACG and IDWeek Conferences

Focus on FMT and the Universal Stool Bank Model in the Gastroenterology and Infectious Disease Communities

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MEDFORD, Mass -- OpenBiome’s research team recently presented multiple oral plenaries and posters on research into fecal microbiota transplantation (FMT) at both Infectious Disease Week 2015 and the American College of Gastroenterology 2015 Annual Scientific Meeting. OpenBiome’s abstracts were selected from hundreds of submissions, and covered topics that included the efficacy and cost-effectiveness of microbiota treatments for recurrent Clostridium difficile, and OpenBiome’s patented capsule delivery method.

OpenBiome, a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplants (FMT), provides treatments for patients with recurrent Clostridium difficile (rCDI), as well as other diseases investigated through clinical trials. OpenBiome aims to significantly reduce the practical barriers for clinicians providing FMTs, while supporting research scientists and physicians using FMTs or investigating the role of the microbiome in human health.

Reflecting a new emphasis on the importance of FMT within the field of gastroenterology, ACG hosted a key session evaluating studies and outcomes of the procedure. Colleen Kelly, MD, FACG, a member of OpenBiome’s Clinical Advisory Board, led the discussion with the results of her randomized, placebo-controlled, double-blind study which demonstrated that “FMT administered via colonoscopy was significantly more effective than placebo.”[i]

Also at ACG, Zain Kassam, MD, MPH, Chief Medical Officer at OpenBiome, was selected to give an oral plenary on the cost-effectiveness of providing FMT through OpenBiome’s universal donor model, demonstrating an incremental direct cost savings of up to $3,661 compared to vancomycin (the standard antibiotic treatment for rCDI).[ii] Additionally, OpenBiome’s poster entitled “Microbial Emulsion Matrices: A Novel Method to Produce Stable, Orally Available Capsules for Fecal Microbiota Transplantation to Treat Clostridium difficile,” covered the technology that OpenBiome developed, enabling the first scalable capsules.[iii] OpenBiome’s second poster, “Novel Safety Features in [FMT] for [rCDI]: Quality Assurance and Adverse Events Workflow,” showcased OpenBiome’s next-generation safety program.

At ID Week, OpenBiome’s poster presentation on donor selection was also included in Posters in the Park, a program designed to highlight promising work to thought leaders in the infectious diseases space. Entitled “Prospective Assessment of Donor Eligibility for Fecal Mirobiota Transplantation at a Public Stool Bank: Results From the Evaluation of 1,387 Candidate Donors,” this poster covered the rigorous screening criteria OpenBiome utilizes for selecting stool donors, and shared the most common issues for which prospective donors are excluded.

The ACG conference was held in Honolulu, Hawaii, from October 16th-21st, and ID Week was held from October 7th-11th in San Diego, CA. More information about OpenBiome, including its mission, patient stories, and Quality & Safety Assurance program, is available at openbiome.org.

Fecal transplant pills: Large-scale production begins following successful dosing study

Nonprofit stool bank launched by MIT researchers will provide the first fecal transplant pill for clinical use

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MEDFORD, Mass — A new pill created by a team of MIT-trained researchers provides fecal transplant therapy without requiring the traditional, more invasive stool delivery methods.

The FMT Capsule G3 pills will serve as a treatment option for recurrent Clostridium difficile infections (rCDI) that don’t respond to standard antibiotic treatment. The pill will also serve as a new tool for researching future applications of microbiome-based therapies.

Fecal microbiota transplantation, or FMT, is procedure in which a stool preparation from a healthy human donor is infused into the intestine of a patient. It is typically delivered via colonoscopy, enema, or a plastic tube inserted through the nose into the stomach or intestines. 

Delivering fecal microbiota transplantation by pill reduces both the procedural costs and risks associated with the more invasive delivery methods. It was the strongly preferred by patients in a survey published in Clinical Infectious Diseases.

The pill was created by OpenBiome, a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation therapies and catalyzing research into the human microbiome. Founded in 2012 by a team of microbiologists, clinicians, and public health advocates from Harvard and MIT, OpenBiome has since provided over 7000 treatments to more than 450 clinical partners across six countries, and has supported 10 clinical and translational research studies.

OpenBiome’s FMT Capsule G3 uses a patent-pending Microbial Emulsion Matrix (MEM) technology, which preserves the viability of complex bacterial communities while ensuring capsules’ long-term physical stability. This feature allows for widespread provision of a fecal transplant pill—encapsulation methodologies used in the field to date have yielded capsules that degraded within minutes. The MEM technology was presented at the American College of Gastroenterology’s annual scientific meeting on October 18th.   

Fecal microbiota transplantation has been shown across multiple studies to be 89 percent effective in treating Clostridium difficile infection, while standard antibiotic therapies yield cure rates of less than 40 percent. C. difficile is the most common hospital-acquired infection in the U.S., and one in five patients with C. difficile will have to endure the infection more than once.

Results from a pilot, multi-center randomized dose-finding study with 17 patients led by Dr. Monika Fischer, MD, MSCR, Clinical Assistant Professor of Medicine at Indiana University, and Dr. Jessica Allegretti, MD, MPH, associate gastroenterologist at Brigham and Women’s Hospital and instructor of medicine at Harvard Medical School, found an initial efficacy rate of 70 percent in both low and high dose groups receiving OpenBiome’s FMT capsules. Treatment with a high dose after an initial nonresponse yielded an aggregate clinical cure rate of 94 percent. There were no adverse events reported.

The results, presented on Monday morning at an award-winning late-breaking oral presentation at United European Gastroenterology Week in Barcelona, Spain, are comparable to previously published investigations of the efficacy of encapsulated FMT. The abstract may be viewed using the conference’s online program tool.

“This is a compelling step towards providing evidence-based FMT capsule treatments for patients,” said Dr. Zain Kassam, MD, MPH, Chief Medical Officer of OpenBiome. “Although colonoscopic delivery remains the gold standard for FMT in terms of efficacy, these results suggest that FMT capsules may emerge as an effective and less invasive therapy option. We hope to help usher in a universe in which patients suffering from this crippling diarrheal infection have safe access to FMT without having to undergo a procedure.”

Similar to other microbiota preparations already provided by OpenBiome, FMT Capsule G3 may be used to treat patients with rCDI under the FDA's enforcement discretion guidelines, or to treat other conditions under an Investigational New Drug application. Encapsulated FMT is a particularly useful tool for clinical research because it allows investigators to evaluate maintenance FMT therapy without requiring participants to undergo repeated invasive procedures.

“OpenBiome’s FMT Capsule G3 is a major step forward for FMT patients, physicians, and clinical researchers because it reduces the procedure-related risks and discomforts of FMT,” said Dr. Mark Smith, PhD, Research Director at OpenBiome. “We have already seen the remarkable impact of standardizing FMT for the treatment of rCDI through traditional routes of administration, and we are thrilled to add capsules as a new option to further expand patients’ safe access to care.”

To learn more about OpenBiome’s FMT Capsule G3, please visit www.openbiome.org/fmtcapsules.

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OpenBiome launches personalized microbiome banking service

The service will allow individuals to preserve a copy of their healthy microbiome for the treatment of C. difficile infection.

October 13, 2015
Contact: Sasha Lieberman, media@openbiome.org |  617-575-2201|  www.openbiome.org
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Medford, Mass – A new pilot service launched at OpenBiome, the first and largest public stool bank, will allow individuals to cryogenically preserve a sample of their fecal microbiota.  In the event that they require a fecal transplant for the treatment of recurrent C. difficile infection, participants may use their banked samples for the procedure.

Fecal microbiota transplantation, or FMT, is a procedure in which a stool preparation from a healthy human donor is infused into the colon of a patient. It’s typically delivered via colonoscopy, enema, or a nasogastric tube.

Fecal microbiota transplantation has been shown across multiple studies to be 89 percent effective in curing Clostridium difficile infection, while standard antibiotics yield cure rates of less than 40 percent.  C. difficile is the most common hospital-acquired infection in the U.S., and one in five patients with C. difficile will have to endure the infection more than once.

OpenBiome is a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation and catalyzing research into the human microbiome. Founded in 2012 by a team of microbiologists, clinicians, and public health advocates from Harvard and MIT, OpenBiome has since provided over 7,000 treatments to more than 400 partner medical centers in six countries, and has supported 10 clinical and translational research studies.     

OpenBiome’s stool banking model provides rigorously screened material from universal stool donors for the treatment of recurrent C. difficile infections. However, there may be advantages to repopulating an individual’s gut with their own healthy microbial community, withdrawn from their PersonalBiome bank. PersonalBiome participants will also be eligible to receive a range of customized screening, sequencing, consultation, processing, encapsulation, and cryopreservation services.

OpenBiome will also work with hospitals and clinics serving patients who are at higher risk of contracting the infection to facilitate their participation in the new program.

“We’re thrilled to offer OpenBiome’s bio-banking services to individuals for their personal use,” said James Burgess, Co-founder and Executive Director of OpenBiome. “While we remain committed to treating patients with recurrent C. difficile following our universal donor model, we are pleased to respond to growing demand for a service that allows individuals to undergo FMT treatment with their own unique microbial communities.”

Individuals or hospital representatives who wish to learn more about participating in the PersonalBiome pilot launch should contact personalbiome@openbiome.org and refer to www.openbiome.org/personalbiome

OpenBiome is a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation (FMT) therapies. Founded by a team of microbiologists, public health advocates, and concerned citizens, OpenBiome aims to significantly reduce the practical barriers for clinicians providing FMTs, while connecting scientists across studies and disciplines. 

OpenBiome brings its fecal microbiota transplantation treatments to Europe

Update May 25th, 2018:

OpenBiome is no longer providing fecal microbiota transplantation (FMT) material to the European Union (EU) due to the General Data Protection Regulation (GDPR) that went into effect May 25, 2018. 

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The stool bank is working with the APC Microbiome Institute in Cork, Ireland to bring rigorously screened, ready-to-use fecal microbiota preparations to European patients suffering from recurrent C. difficile infections. 

Cork, Ireland – OpenBiome announced today that it will make its microbiota preparations for fecal microbiota transplantation (FMT) available to patients across Europe suffering from recurrent C. difficile infections.

C. difficile, one of the most common hospital-acquired infections, is an aggressive intestinal illness that can cause debilitating and potentially life-threatening diarrhea. C. difficile infects an estimated 145,000 people in the EU each year. Each case costs between €5,000-€15,000 to treat, resulting in estimated costs of over €3.7 billion annually to European healthcare systems.

FMT is a powerful treatment option for this infection. While standard antibiotic therapies resolve multiply recurrent C. difficile infection about 30% of the time, FMT has a cure rate of 85-90%. However, the expense and inconvenience of finding and screening suitable stool donors often limits the use of FMT.

OpenBiome, a nonprofit stool bank, overcomes barriers by providing hospitals and clinics with rigorously screened fecal microbiota preparations. By dividing the donor screening costs across multiple treatments prepared from each donor, OpenBiome provides treatments for a fraction of the cost of either a physician-directed process or of antibiotic treatment options. Founded by a team of microbiologists and public health advocates at MIT, OpenBiome has facilitated more than 5,000 fecal transplants across 350 hospitals in 49 U.S. states and 6 countries.

OpenBiome is collaborating with the Alimentary Pharmabiotic Centre (APC) Microbiome Institute, a research center based at the University College Cork, to work with clinicians, researchers, and regulators to adapt OpenBiome’s stool banking model to the European context, and import its microbiota preparations beginning in Ireland and the UK.

European physicians who are interested in using OpenBiome’s material to treat C. difficile patients or to conduct research studies should contact info@openbiome.org.

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OpenBiome provides its 5000th treatment

After experiencing a rapid growth in demand for its clinical treatments, OpenBiome is on track to treat 1-in-10 patients in the U.S. suffering from C. difficile by end of year.

 

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Medford, MA - Following only ten months after marking 1000 treatments provided, OpenBiome shipped its 5000th treatment for recurrent Clostridium difficile yesterday.

C. difficile, one of the most common hospital-acquired diseases, infects roughly half a million Americans every year, with 30,000 deaths as a result.  While often initially treatable with antibiotics, about 1 in 5 patients experience multiple recurrences. OpenBiome’s fecal microbiota preparation (FMT) is used to treat recurrent C. difficile at over 400 partner hospitals across the country. FMT involves transplanting carefully screened, processed stool from a healthy donor into a sick patient’s colon.

With FMTs shown to be around 90% effective across several clinical studies, providing heavily screened, processed treatments at-cost is essential to lowering the access barrier and making an impact on the prevalence of C. difficile. As such, OpenBiome last year announced its initiative to treat 1 in 10 patients across the U.S. suffering from recurrent C. difficile.

“Reaching 5000 treatments so quickly after OpenBiome’s 1000th treatment supplied, this marks a milestone in OpenBiome’s rapid expansion over the past two years,” said James Burgess, co-founder and Executive Director. “This success is on track with OpenBiome’s projections for the necessary growth to provide treatments for 1-in-10 patients in the U.S. with recurrent C. difficile by end of year, making a significant impact on this national health burden.”

The rapid growth of this service is due to the ease and cost-effectiveness for physicians using OpenBiome material. Providing at-cost, rigorously screened material takes the burden off the physician to find and coordinate with an eligible donor, and to process the fecal material. OpenBiome is committed to simplifying and lowering the cost of FMT, to enable access and thereby combat the spread of recurrent C. difficile.

 

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OpenBiome begins enrolling patients in first prospective longitudinal safety study for FMT

Researchers at nonprofit stool bank begin recruiting participants for study investigating the long-term safety of FMT for treating recurrent C. difficile

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Medford, Mass – Researchers at OpenBiome have launched a clinical trial investigating the long-term safety and efficacy of fecal microbiota transplantation (FMT) for treating patients with recurrent Clostridium difficile infection (rCDI) that is not responding to standard antibiotic therapies. Called the STOOL study, this trial is an important step forward for the field as it seeks to provide data-driven evidence to support the long-term safety profile of FMT.

FMT is a procedure in which a stool preparation from a healthy human donor is infused into the colon of a sick patient. It is typically delivered via colonoscopy, enema, or a plastic tube inserted through the nose leading to the intestines. While antibiotics can yield cure rates of less than 40%, FMT has been shown across multiple studies to be 89% effective in treating rCDI. However, studies so far have focused on short-term safety and efficacy outcomes, leaving open questions about the long-term safety profile of a treatment that medical societies advocate as the standard of care for treating rCDI.

The study, titled “Safety of fecal microbiota Transplantation: OpenBiome Outcomes and Longitudinal follow-up for recurrent Clostridium difficile” (STOOL) will be the first to provide long-term safety data for patients who have undergone an FMT for the treatment of rCDI. Dr. Colleen Kelly of Brown Medical Center enrolled the first patients this year, and six other clinical sites are on track to begin recruiting next year. Study collaborators aim to enroll a total of 150 participants, who will be followed for one-year post-FMT procedure.

Adults who have had 3 episodes of C. difficile infections and have not experienced long-lasting clinical resolution following antibiotic therapy are eligible to participate. They will receive an FMT administered by lower delivery, most often by colonoscopy or enema, and then be monitored for one year. At various follow-up points, research staff will contact them to determine if their C.difficile-associated symptoms have resolved, examine their stool microbiome, and assess if they have experienced any negative symptoms or health events that may be attributed to FMT. Beyond long-term safety, the results will also be able to tell if there is a microbial signature that predicts a clinical response, non-response or, if they occur, an adverse event.

“This multi-center, prospective longitudinal study will help inform our collective understanding of the long-term safety of this exciting microbial therapy,” says Dr. Zain Kassam, Chief Medical Officer at OpenBiome. “The body of evidence in this field suggests FMT is a safe intervention and many medical societies advocate for FMT as the standard of care for treating patients with recurrent C. difficile. However, no study has yet rigorously evaluated the long-term safety profile of FMT. We initiated the STOOL study because we believe it will be an important step to validate the promising outcomes clinicians have seen at the patient’s bedside.” 

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OpenBiome Receives Grant to Expand its FMT Capsule Program

Funding from the Neil and Anna Rasmussen Foundation enables large-scale production of new capsule formulation

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Medford, MA – Just a few months after developing the first fecal microbiota transplant (FMT) pill, OpenBiome is announcing an award of $225,000 from the Neil and Anna Rasmussen Foundation to enable scaling of OpenBiome’s capsule program. This grant will allow OpenBiome to build out the infrastructure necessary for scaled production, including equipment for purchases, and dose-finding and clinical validation studies. 

Fecal microbiota transplantation is a procedure in which a stool preparation from a healthy human donor is infused into the intestine of a patient, previously typically delivered via colonoscopy, enema, or nasoenteric tube.

OpenBiome’s recently developed, uniquely scalable FMT pill reduces both the procedural costs and risks associated with the more invasive delivery methods. Utilizing OpenBiome’s patent-pending Microbial Emulsion Matrix (MEM) technology, FMT Capsules G3 ensures long-term stability, allowing for shipping and storage time before delivery.

“The generous funding from the Rasmussen Foundation will provide OpenBiome with the capital required to build out a scalable production infrastructure to make capsules in quantities in line with current and anticipated clinical need,” said James Burgess, Executive Director at OpenBiome. “This program is a promising and necessary step forward in the space to further expand patients’ access to FMT, both in cost and ease of procedure.”

About the Rasmussen Foundation

The Neil and Anna Rasmussen Foundation is an independent foundation involved in natural resource conservation, education, human services, and healthcare. The Foundation has supported OpenBiome in past years, providing capital for growth. Neil Rasmussen, M. Eng., co-founder of the foundation, is on OpenBiome’s Board of Directors.

 

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OpenBiome Receives Grant from the Anna-Maria and Stephen Kellen Foundation

Funding from the Kellen Foundation triples OpenBiome’s pro bono fund and provides funding for capsule research

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MEDFORD, Mass - The Kellen Foundation is a private nonprofit foundation based in New York. As one of the largest charitable organizations in the U.S., the Kellen Foundation supports programs and organizations across the arts, higher education, and health care research, including the Cancer Research Institute and the Physician-Scientist Career Development Program at the Hospital for Special Surgery.

OpenBiome is a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation (FMT) and catalyzing research in the human microbiome. Founded by a team of microbiologists and public health advocates at MIT, OpenBiome has facilitated more than 4,000 fecal transplants across 300 hospitals in 46 U.S. states and 5 countries.

Fecal microbiota transplantation is procedure in which a stool preparation from a healthy human donor is infused into the colon of a patient with recurrent Clostridium difficile (rCDI), one of the most common hospital-acquired infections in the U.S. It is typically delivered via colonoscopy, enema, or a tube inserted through the nose into the stomach or intestines. 

This grant funds additional research for OpenBiome’s newly-developed, scalable encapsulated fecal material. The FMT Capsule G3 pills will serve as an alternative delivery method for patients looking to avoid the more invasive treatment options.

Lastly, the Kellen Foundation’s grant will support the fund that OpenBiome maintains to provide FMT treatments free-of-charge for patients in financial need. OpenBiome provides its treatments at-cost, but also strives to ensure that every patient has access to this treatment regardless of financial circumstances. By providing OpenBiome with funds to not only maintain but expand this program, the Kellen Foundation’s donation ensures that patients in need of FMT material will not be prohibited by cost.

To request more information on OpenBiome’s pro-bono fund, please contact OpenBiome’s clinical outreach team at info@openbiome.org, or call 617-575-2201, ext. 3.

 

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