Significant company milestones include completion of the Phase 2 PUNCH™ CD clinical trial and FDA designation of RBX2660 as Orphan Drug and Fast Track
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ROSEVILLE, Minn. (August 04, 2014) — Rebiotix Inc. announced this morning that it has raised a total of $25 million in Series B Funding. The total funds raised since inception by the clinical-stage biotechnology company founded in 2011 is $30 million.
Rebiotix will use the additional funds to support pivotal clinical research to advance lead product RBX2660 (microbiota suspension) towards commercialization; for research and development on next-generation therapeutic products; for potential new treatment indications; and for general working capital.
Rebiotix’s goal is to revolutionize the treatment of challenging gastrointestinal diseases by harnessing the power of the human microbiome. The company is developing an entirely new category of biologic drugs designed to reverse pathogenic processes responsible for disease through the transplantation of live human-derived microbes. RBX2660 is a non-antibiotic treatment under study for recurrent Clostridium difficile (C. diff.) infection.
Recent company milestones:
Completion of the Phase 2 PUNCH™ CD clinical trial
The recently completed PUNCH CD study of RBX2660 is the first prospective multicenter clinical trial of a standardized, commercially prepared Microbiota Restoration Therapy™ Drug Platform for recurrent C. diff. The study was conducted under a US Food and Drug Administration (FDA) investigational new drug (IND) application. Results of this study will be presented in October at the annual meetings of the American College of Gastroenterology (ACG) and IDWeek 2014.
FDA designation of RBX2660 as an Orphan Drug
Rebiotix is the only company that has a microbiota therapy with FDA orphan-drug designation for treatment of recurrent C. diff. infection. Orphan drugs are those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and/or disorders that affect fewer than 200,000 people in the US.
Designation as an FDA Fast Track product
The FDA designated RBX2660 as a Fast Track product for the treatment of recurrent C. diff. infection. This designation underscores the urgent need for a new therapy to treat patients who have this debilitating and potentially life-threatening disease and means that FDA will act to expedite the development and review of the application for the product, as appropriate.
“It’s a very exciting time to be studying the human microbiome and the benefits that may possibly be derived from it. We are working on the leading edge of medicine in developing non-antibiotic alternatives to treat infections caused by drug-resistant strains of bacteria,” said Lee Jones, Founder, President and CEO of Rebiotix Inc.
“C. diff. in particular is an urgent public health threat,” continued Jones. “Cases are growing and increasing in virulence. With RBX2660, we are making tremendous progress towards delivering the first commercially available microbiota therapeutic targeted at treating C. diff. in patients who have failed standard therapy and who have recurrent disease. This new round of funding will enable us to drive forward to this goal.”
Rebiotix is currently working with the FDA to finalize plans for additional clinical studies needed to achieve regulatory approval for RBX2660.
Rebiotix Inc. is a results-oriented biotechnology company revolutionizing the treatment of challenging gastrointestinal diseases by harnessing the power of the human microbiome. The Roseville, Minn. based company is pioneering Microbiota Restoration Therapy Drug Platform to restore healthy gut flora through the transplantation of live microorganisms. For more information, visit www.rebiotix.com.
This press release contains forward-looking statements concerning such matters as the Company’s goals, plans, future activities and other expectations. All matters that are addressed by such statements are subject to a number of uncertainties, risks, and other influences, many of which are outside the control of Rebiotix, and any one or any combination of which could materially and adversely affect whether those forward-looking statements ultimately prove to be accurate. Although Rebiotix believes that the expectations reflected in the forward-looking statements are generally reasonable as of the date of this press release, it can give no assurance that such expectations will ultimately prove to be correct.