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Results of Study Assessing Microbiota-based Drug Targeted at Recurrent C. difficile Infection to be Presented at ACG 2014

Rebiotix lead drug candidate RBX2660 (microbiota suspension) assessed in PUNCH CD study


News provided by

Rebiotix Inc.

Oct 01, 2014, 10:33 ET

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ROSEVILLE, Minn., Oct. 1, 2014 /PRNewswire/ -- Rebiotix Inc. announced this morning that results of PUNCH CD, a Phase 2 study of the company's lead product candidate, RBX2660 (microbiota suspension), will be presented in three posters at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Philadelphia from October 17-22.

The following poster will be presented on Monday, October 20, 2014:

P951: Enema Administration of RBX2660 (microbiota suspension) for Recurrent C. difficile Infection: Lessons Learned from the PUNCH CD Study

  • Arnab Ray, MD, Ochsner Clinic, New Orleans, LA
  • Robert Hardi, MD, Capital Digestive Care, Chevy Chase, MD
  • Mayur Ramesh, MD, Henry Ford Health System, Detroit, MI
  • Mary Kay Sobcinski, RN, MHA, Rebiotix Inc., Roseville, MN

The following posters will be presented on Tuesday, October 21, 2014:

P1542: RBX2660 (microbiota suspension) for Recurrent C. difficile Infection: 60-Day Interim Analysis of the PUNCH-CD Phase 2 Safety Study

  • Mayur Ramesh, MD, Henry Ford Health System, Detroit, MI
  • Bharat Misra, MD, Borland-Groover, Jacksonville, FL
  • Arnab Ray, MD, Ochsner Clinic, New Orleans, LA
  • Robert Smith, MD, Ochsner Clinic, New Orleans, LA
  • Mary Kay Sobcinski, RN, MHA, Rebiotix Inc, Roseville, MN

P1548: Evaluation of Health-Related Quality of Life in Patients Treated with RBX2660 (microbiota suspension) for Recurrent C. difficile Infection

  • Bharat Misra, MD, Borland-Groover, Jacksonville, FL
  • Mayur Ramesh, Henry Ford Health System, Detroit, MI
  • Mary Kay Sobcinski, RN, MHA, Rebiotix Inc, Roseville, MN

"C. difficile infection is one of the most common health-care associated infections in the U.S. Currently, there is no indicated treatment for recurrent disease, and many patients are desperate for help," said Lee Jones, President and CEO of Rebiotix. "Our goal from the start was to revolutionize the treatment of this challenging disease. We're very excited to share the results of the PUNCH CD Study at the ACG conference next month."

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. The FDA has also 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. 

About Rebiotix Inc.

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 to restore healthy gut flora through the transplantation of live microorganisms. For more information, visit www.rebiotix.com.

Forward-looking Statements

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.

SOURCE Rebiotix Inc.

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