Tag Archives: Dr Joseph Sliman MD

Ribaxamase Protects the Gut Microbiome and Reduces Risk For New Opportunistic C.diff. Infections According To Phase 2b Study

From IDWeek  2017- SanD iego, CA

 

Ribaxamase is associated with reduced risk for new, opportunistic Clostridium difficile infections (CDI) in hospital patients, according to findings from a multinational, double-blind, placebo-controlled Phase 2b study presented at IDWeek 2017.

 

 

“These data support that ribaxamase can maintain the balance of the gut microbiome and thereby prevent opportunistic infections like CDI during IV beta-lactam treatment,” said lead study author John Kokai-Kun, PhD, of Synthetic Biologics, Inc., Rockville, MD.

“Ribaxamase also protected the diversity of the gut microbiome and reduced the emergence of antibiotic resistance in ceftriaxone-treated patients,” he said.

CDI represent an “urgent threat” but there are no FDA-approved drugs or vaccines to prevent infections, Dr. Kokai-Kun noted.

“SYN-004 (ribaxamase) is a beta-lactamase designed to be orally administered with IV beta-lactam antibiotics and remain localized in the intestine to degrade antibiotics excreted into the intestine,” he said. “This is expected to protect the gut microbiome from disruption thus preventing deleterious effects including, CDI, colonization by opportunistic pathogens and emergence of antibiotic resistance in the gut microbiome.”

“Ribaxamase was well tolerated and not systemically absorbed in Phase 1 studies and efficiently degraded ceftriaxone excreted into the human intestine while not altering the plasma pharmacokinetics of ceftriaxone in Phase 2a studies,” he told the IDWeek audience.

The researchers conducted their study to assess if ribaxamase prevents new-onset CDI. They also assessed non-CDI antibiotic-associated diarrhea, colonization by opportunistic pathogens, gut microbiome alterations and acquired antibiotic resistance.

Data from 412 patients (man age 70 years) in the intention-to-treat population “enriched for higher risk for CDI” were hospitalized for ≥5 days of IV ceftriaxone for treatment lower respiratory tract infections,” Dr. Kokai-Kun said. Patients were randomly assigned 1:1 to receive oral ribaxamase 150mg four times daily or placebo during IV ceftriaxone treatment and for an additional 72 hours.

“Fecal samples were collected at pre-specified points for determination of colonization by opportunistic pathogens and to examine changes in the gut microbiome,” Dr Kokai-Kun said. Patients were monitored for 6 weeks for CDI, defined as diarrhea plus the presence of C. difficile toxin.

Study participants saw a 71% relative risk reduction in CDI (P=0.045) and a statistically significant 44% relative risk reduction in new colonization by vancomycin-resistant enterococci (P=0.0002). Moreover, the respiratory infection was cleared in ~99% of cases demonstrating that concomitant ribaxamase did not impact the cure rate of ceftriaxone.

For continuous infectious disease news coverage from the IDWeek 2017, check back to MPR’s IDWeek page for the latest updates.

Reference: 

Kokai-Kun J, Roberts T, Coughlin O, Whalen H, Le C, Da Costa C, Sliman J. SYN-004 (ribaxamase) prevents New Onset Clostridium difficile Infection by Protecting the Integrity Gut Microbiome in a Phase 2b Study. Poster presented at IDWeek; October 4–8, 2017; San Diego, CA. http://www.idweek.org/.

 

 

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.

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