PUNCH CD Study Drug Targeting Recurrent C. difficile Infection to be Presented at IDWeek 2014


Rebiotix microbiota-based drug candidate used to assess a non-antibiotic approach to an urgent public health threat


Download this press release (404 KB).

ROSEVILLE, Minn. (September 17, 2014) — Rebiotix Inc. announced this morning that results of the Phase 2 study of the company’s lead product candidate, RBX2660 (microbiota suspension) will be presented in two posters and a podium presentation during the IDWeek 2014 conference in  Philadelphia from October 8-12.

PUNCH CD study results will be presented during the poster session on Thursday, October 9, 2014:

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

  • Erik Dubberke, MD, MSPH, Division of Infectious Diseases, Washington University School of Medicine, St. Louis, MO
  • Robert Orenstein, DO, Infectious Diseases, Mayo Clinic Arizona, Phoenix, AZ
  • Paul Mariani, MD, Infectious Disease, Sanford Health, Fargo, ND
  • Kathleen Mullane, DO, FIDSA, University of Chicago Medicine, Chicago, IL
  • Mary Kay Sobcinski, RN, MHA, Rebiotix Inc, Roseville, MN

Additional results will be presented during sessions on Saturday, October 11, 2014:

Poster: Who Seeks a Fecal Microbiota Transplant for Recurrent C. difficile Infection?: Patient Profile of the PUNCH CD Study

  • Robert Orenstein, DO, Infectious Diseases, Mayo Clinic Arizona, Phoenix, AZ
  • Erik Dubberke, MD, MSPH, Infectious Disease, Washington University School of Medicine, St. Louis, MO
  • Cheryl Griesbach, RN, Clinical Studies Unit-Phoenix, Mayo Phoenix, Phoenix, AZ
  • Mary Kay Sobcinski, RN, MHA, Rebiotix Inc, Roseville, MN

Podium Presentation: Saturday, October 11, 2014 at 3:15 PM as part of the “Clostridium difficile: Treatment and Prevention” session:

Next Generation Fecal Transplant for Recurrent C. difficile Infection with and without Antibiotic Pre-Treatment: Lessons Learned from the PUNCH CD Phase 2 Safety Study

  • Dr. Paul Mariani, Sanford Health, Fargo, ND  will present on behalf of co-investigators:
  • Connie S. Price, MD, Department of Medicine, Division of Infectious Diseases, Denver Health Medical Center, Denver, CO
  • Robert Orenstein, DO, Infectious Diseases, Mayo Clinic Arizona, Phoenix, AZ
  • Hill Harris, MD, MPH, Denver Health Medical Center, Denver, CO

“We are excited to present our Phase 2 findings at IDWeek, since this is the first prospective multicenter clinical trial of a standardized, commercially prepared microbiota restoration therapy to be completed,” said Lee Jones, Rebiotix CEO, president and founder. “We are on track to begin a Phase 2b randomized controlled double blind trial allowing for us to advance in our pursuit to treat this awful disease.”

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

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.


About IDWeek 2014

IDWeek is the combined annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS).  The meeting provides the opportunity for internationally recognized leaders to discuss the latest science and clinical advancements in the field of infectious disease including the prevention, diagnosis, treatment and epidemiology.


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.

Media Relations Contact:
Brendan Paul
brendan@nullthechtgroup.com
617-226-7184