Tag Archives: Intestinal Microbiome

Rebiotix, a Ferring Company, Completes Enrollment for First-Ever, Pivotal Phase 3 Clinical Trial RBX2660

Rebiotix, a Ferring Company, completes enrollment for first-ever, pivotal Phase 3 Clinical Trial of Microbiota -based RBX2660

Enrollment completion for the first Phase 3 clinical trial in microbiome industry

 The largest randomized, double-blinded study, with over 300 patients enrolled aimed to demonstrate the potential benefit of RBX2660 in reducing rates of recurrent Clostridioides difficile (C. diff) infection

 Rebiotix intends to use the results from the Phase 3 trial to serve as the basis for licensure application to the US Food and Drug Admin (FDA)

 Saint-Prex, Switzerland – On February 4, 2020

Rebiotix, a Ferring company, announced today that it has completed enrollment of the pivotal Phase 3 clinical trial for RBX2660, an investigational therapy aimed at breaking the cycle of recurrent Clostridioides difficile (C. diff) infection, which is responsible for the deaths of thousands of people in the US alone. The Centers for Disease Control and Prevention (CDC) has classified C. diff as an urgent public health threat, with limited options for treatment.

 

RBX2660 was developed under Rebiotix’s investigational microbiota-based MRT™ drug platform with the goal of delivering standardized, stabilized formulations to meet unmet medical needs. Conducted in the US and Canada, this is the first Phase 3 trial of its kind to be completed using a broad consortia microbiota-based formulation.

 

“Rebiotix was founded to harness the power of the human microbiome to treat debilitating diseases,” said Lee Jones, Rebiotix Founder, and CEO. “Microbiota-based therapies have shown tremendous potential as an innovative, non-antibiotic therapy, starting with C. diff. The completion of enrollment of this trial is a critical next step in making microbiota-based products accessible to patients – we are excited about this important milestone and look forward to sharing results later this year.”

 

The Phase 3 trial builds on the company’s extensive history with the formulation, including several hundred participants previously enrolled in multiple Phase 2 clinical trials. The robust data collected over the course of the company’s multi-year clinical development program will be eventually presented to the US FDA as part of a Biological License Application (BLA).

 

Ferring Pharmaceuticals, also with a rich and vast history of microbiome research of its own, led the industry by becoming the first major pharmaceutical company to acquire a microbiome therapeutics company in April 2018. Headquartered in Saint-Prex, Switzerland, Ferring is expected to have the first regulatory approved microbiota-based therapeutic in the world through the potential approval of the RBX2660 in the US.

 

About Clostridioides difficile Infection

Clostridioides difficile (also known as C. diff) is a bacterium that causes diarrhea and colitis (inflammation of the colon). C. diff, impacts nearly a half a million people each year in the United States; of those impacted, up to one in five patients will experience a recurrent episode.1 In 2019, the U.S. Centers for Disease Control listed C. diff as an urgent threat to public health.2

 

About RBX2660

RBX2660 is currently in Phase 3 clinical development for the reduction of recurrent Clostridioides difficile (C. diff) infection. RBX2660 has been granted Fast Track, Orphan, and Breakthrough Therapy Status designations from the US FDA. For more information about the RBX2660 Phase 3 study, visit http://www.clinicaltrials.gov (NCT03244644).

 

About Rebiotix

Rebiotix Inc., 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 challenging diseases. Rebiotix has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRT™ drug platform. The platform consists of investigational drug technologies designed to potentially rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract. For more information on Rebiotix and its pipeline of human microbiome-directed therapies for diverse disease states, visit http://www.rebiotix.com.

 

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Founded in 1950, privately-owned Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

 

References:

1Centers for Disease Control and Prevention. What Is C. Diff?,17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html.

2Centers for Disease Control and Prevention. Biggest Threats and Data, 14 Nov. 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html.

 

Source:  Rebiotix, Press Release

http://www.rebiotix.com

PODCAST of June 28th C. diff. Spores and More With Guests Dr. Sliman & Dr. Pimentel As We Discuss Synthetic Biologics: Protecting the Gut Microbiome and Maintaining Human Health

 

Listen to the PODCAST of the live broadcasted

on  June 28th,  2016

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Listen in to the live broadcast at 10a PT,   11a MT,   12p CT,   1p ET


C. diff. Spores and More,”™ Global Broadcasting Network – innovative and educational interactive healthcare talk radio program discusses

This Episode:  

Synthetic Biologics: Protecting the Gut Microbiome
and Maintaining Human Health

With Our Guests:

Dr. Joseph Sliman, MD
Senior Vice President, Clinical & Regulatory Affairs

Dr. Mark Pimentel, MD, FRCP(C)
Director of the GI Motility Program and Laboratory at Cedars-Sanai

On Tuesday, June 28th  we discussed public awareness of the microbiome and its link to human health – is on the rise as evidenced by recent government-sponsored programs such as the National Microbiome Initiative.  Protection of the natural gut microbiome from the unintended consequences of intravenous (IV) antibiotics, which are excreted into the gut, is expected to protect against opportunistic enteric infections.   Recent clinical data suggest that the absence or abundance of certain microbes may be directly linked to certain infections and diseases including a Clostridium difficile infection (CDI), and irritable bowel syndrome (IBS).   Synthetic Biologics is developing two microbiome-focused drug candidates in Phase 2 development including SYN-004 which is designed to protect the gut microbiome by degrading certain IV beta-lactam antibiotics for the prevention of a CDI, antibiotic associated-diarrhea (AAD) and the emergence of antibiotic-resistant organisms.  And SYN-010 is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C).   Synthetic Biologics Inc.’s Joseph Sliman, MD, Senior Vice President, Clinical and Regulatory Affairs with Mark Pimentel, MD, FRCP(C), Director of the GI Motility Program and Laboratory at Cedars-Sinai, will be discussing both the Company’s novel microbiome-focused product candidates.

 

MORE ABOUT OUR GUESTS:

Dr Joseph Sliman, MD, Senior Vice President, Clinical and Regulatory Affairs.

Dr. Sliman joined Synthetic Biologics in January 2013 as the Senior Vice President, Clinical & Regulatory Affairs. In this position, Dr. Sliman will be responsible for the design and implementation of all aspects of clinical development, including clinical trials, and will lead the Company’s regulatory initiatives. During his service in the United States Navy, Dr. Sliman led the U. S. Pacific Fleet disease surveillance programs, including influenza surveillance, preparedness, and prevention, as well as communicable disease and injury surveillance and prevention and health policy development. Dr. Sliman earned an M.D. from the Uniformed Services University, a Master’s Degree in Public Health from the Johns Hopkins University School of Public Health, and a B.S. in Molecular and Cell Biology, with Honors in Biology, from Pennsylvania State University

Dr Mark Pimental, MD, FRCP(C), Director of the GI Motility Program and
Laboratory at Cedars-Sanai.

Mark Pimentel, MD, FRCP(C), is Director of the GI Motility Program and
Laboratory at Cedars-Sinai, Associate Professor of Medicine at CSMC and Professor of Medicine at UCLA Geffen School of Medicine in Los Angeles, CA. Dr. Pimentel completed three years of undergraduate degree with honors in microbiology and biochemistry at the University of Manitoba, Canada. This was followed by his medical degree and his BSc(Med) from the Univeristy of Manitoba Health Sciences Center in Winnipeg, Manitoba, Canada where he also completed a residency in internal medicine. His medical training includes a fellowship in gastroenterology at the UCLA Affiliated Training Program. Active in research Dr. Pimentel has served as a principal investigator or co-investigator for numerous basic sciences, transitional, and clinical studies in such areas as IBS, and the relationship between gut flora composition and human disease.

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C. diff. Spores and More ™“ Global Broadcasting Network spotlights world renowned topic experts, research scientists, healthcare professionals, organization representatives,C. diff. survivors, board members, and C Diff Foundation volunteers who are all creating positive changes in the C. diff. community worldwide.

Through their interviews, the C Diff Foundation mission will connect, educate, and empower many worldwide.

Questions received through the show page portal will be reviewed and addressed  by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP,  Dr. Fred Zar is a Professor of Clinical Medicine, Vice HeZarPhotoWebsiteTop (2)ad for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago.  Over the last two decades he has been a pioneer in the study of the treatment of
Clostridium difficile disease and the need to stratify patients by disease severity.

To access the C. diff. Spores and More program page and library, please click on the following link:    www.voiceamerica.com/show/2441/c-diff-spores-and-more

 

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