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Microbiome Therapeutics Innovation Group Statement on FDA Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms

WASHINGTON, June 17, 2019 /PRNewswire/ -- On June 13, 2019, the U.S. Food and Drug Administration (FDA) issued a safety alert regarding the use of fecal microbiota for transplantation, or FMT:

https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-safety-alert-regarding-use-fecal-microbiota-transplantation-and-risk-serious-adverse.

Our MTIG members are committed to the development of therapeutic microbiota-based products that are safe and effective. All of our member companies are developing investigational products in compliance with the FDA guidelines for Investigational New Drugs, including donor testing and/or quality control requirements. We are working actively with the FDA to develop guidelines for the application of pharmaceutical development criteria related to microbiota-based therapeutics and for the evaluation of safety parameters related to microbiota-based therapeutic products. MTIG fully supports the continued vigilance of the FDA in regulating this field to better assure that patients have access to safe and effective treatments.

About the Microbiome Therapeutics Innovation Group

The Microbiome Therapeutics Innovation Group (MTIG) is a coalition of companies leading the research and development of FDA-approved microbiome therapeutics and microbiome-based products to address unmet medical needs, improve clinical outcomes, and reduce health care costs. The human microbiome is one of the new frontiers of medical innovation that has the potential to benefit patients suffering from numerous diseases afflicting millions of patients and consuming billions of dollars of healthcare resources. MTIG is committed to working with stakeholders who share in our mission and seek tangible policy and regulatory solutions in the emerging microbiome arena. Through a collective voice, the MTIG membership works together to enhance the regulatory, investment, and commercial environment to accelerate microbiome therapeutic product development and enable the field to reach its potential to benefit patients. 

Today, the MTIG is comprised of three companies: Rebiotix, Inc., Seres Therapeutics, and Vedanta Biosciences.

All pharmaceutical and biotechnology companies pursuing regulatory approvals for microbiome therapeutics and microbiome-based products are eligible for consideration of membership in MTIG. If you are interested in learning more about becoming a member, please contact us here.

For more information, visit: www.microbiometig.org

About Rebiotix Inc.

Rebiotix Inc, which is part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of debilitating diseases. Rebiotix possesses a deep and diverse clinical pipeline, with its lead drug candidate, RBX2660, in Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff) infection. RBX2660 has been granted Fast Track status, Orphan Drug and Breakthrough Therapy designation from the FDA for its potential to prevent recurrent C. diff infection. Rebiotix's clinical pipeline also features RBX7455, a lyophilized non-frozen, oral capsule formulation, which is entering a Phase 2b clinical trial for the prevention of recurrent C. diff infection. In addition, Rebiotix is targeting several other disease states with drug products built on its pioneering Microbiota Restoration Therapy™ platform. The MRT™ platform is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient's intestinal tract via a ready-to-use and easy-to-administer format.

For more information, visit: www.rebiotix.com 

About Seres Therapeutics, Inc.

Seres Therapeutics, Inc. (MCRB) is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the state of bacterial diversity and function is imbalanced. Seres' lead program, SER-109, has obtained Breakthrough Therapy and Orphan Drug designations from the U.S. Food and Drug Administration and is in Phase 3 development for multiply recurrent C. difficile infection. Seres' clinical candidate SER-287 has successfully completed a Phase 1b study in patients with mild-to-moderate Ulcerative Colitis. Seres is developing SER-262in a Phase 1b study in patients with primary C. difficile infection.  Seres is also developing SER-401 to augment the efficacy of immuno-oncology treatment.

For more information, visit: www.serestherapeutics.com

About Vedanta Biosciences

Vedanta Biosciences is a clinical-stage company developing a new category of therapies for immune-mediated and infectious diseases based on rationally defined consortia of human microbiome-derived bacteria. An affiliate of PureTech Health (PureTech Health plc), Vedanta Biosciences is a leader in the microbiome field with capabilities and deep expertise to discover, develop, and manufacture live bacteria drugs. These include what is believed to be the largest collection of human microbiome-associated bacterial strains, a suite of proprietary assays to select pharmacologically potent strains, vast proprietary datasets from human interventional studies, and facilities for cGMP-compliant manufacturing of rationally-defined bacterial consortia in powder form. Vedanta Biosciences' pioneering work, in collaboration with its scientific co-founders, has led to the identification of human commensal bacteria that induce a range of immune responses - including induction of regulatory T cells, CD8+ T cells, and Th17 cells, among others. These advances have been published in leading peer-reviewed journals including Science (multiple)Nature (multiple), Cell and Nature Immunology. Vedanta Biosciences has harnessed these biological insights and its capabilities to generate a pipeline of programs in infectious disease, autoimmune disease, allergy, and immune-oncology.

For more information, visit: www.vedantabio.com

About The Conafay Group

The Conafay Group, led by Stephen R. Conafay, is a life-sciences government relations firm based in Washington D.C. that serves as Washington counsel and coalition manager for MTIG. The team specializes in representing life sciences companies, universities, and other organizations in the biomedical space before the federal government and associated stakeholders. Services include developing a strategy to secure federal non-dilutive funding, congressional and agency relationship building, alliance development and policy lobbying.

For more information, visit: www.conafaygroup.com

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