Tag Archives: Synthetic Biologics Clinical Studies

SYN-004 (ribaxamase) For C. difficile Prevention Advances; U.S. Food and Drug Administration (FDA) Has Granted A Breakthrough Therapy Designation

On May 11, 2017 Synthetic Biologics, Inc. a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for SYN-004 (ribaxamase) for the prevention of Clostridium difficile infection.

SYN-004 (ribaxamase) is the Company’s first-in-class oral enzyme designed to protect the gut microbiome from disruption caused by certain intravenous (IV) beta-lactam antibiotics.

The Breakthrough Therapy Designation is based on data from the successful Phase 2b clinical trial of ribaxamase, which met its primary endpoint of significantly reducing CDI. FDA Breakthrough Therapy Designation is intended to expedite development and review timelines when preliminary clinical evidence indicates that a drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies for serious or life threatening diseases. If approved by the FDA, SYN-004 (ribaxamase) would be the first available drug designed to prevent Clostridium difficile infection by protecting the gut microbiome from antibiotic-mediated dysbiosis.

“We are delighted by the FDA’s recognition of ribaxamase’s potential to prevent CDI, and the dire need to fill the current void of an approved intervention,” said Jeffrey Riley, President and Chief Executive Officer. “Following this announcement, we have been asked and anticipate requesting a Type-B multidisciplinary meeting with the Agency for a comprehensive discussion on the overarching, high-level drug development plan and pathway to licensure for ribaxamase. We look forward to working closely with the FDA throughout the development and review process and remain dedicated to bringing this potentially paradigm-shifting approach to antibiotic therapy to patients in critical need.”

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Protecting the Gut Microbiome: A Paradigm Shift in Managing GI Disorders

Live Broadcast On Tuesday, May 16th Join us with our guest, Dr. Joseph Sliman, MD, MPH, Chief Medical Officer of Synthetic Biologics.  Dr. Sliman will be discussing  the 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. Synthetic Biologics is developing two microbiome-focused drug candidates in Phase 3 development including, SYN-004 (ribaxamase) which is designed to protect the gut microbiome by degrading certain IV beta-lactam antibiotics for the prevention of Clostridium difficile infection (CDI), pathogenic
overgrowth and the emergence of antimicrobial resistance, and SYN-010 which 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).

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To learn more about Synthetic Biologics, please click on the link provided below

.http://www.syntheticbiologics.com/about/overview

Source:  Synthetic Biologics

Synthetic Biologics – Protecting the Gut Microbiome: A Paradigm Shift in Managing GI Disorders

Centers for Disease Control and Prevention (CDC) Awards Research Contract To Synthetic Biologics For Microbiome Assessment and Approaches To Better Combat Antibiotic Resistance

Synthetic Biologics, Inc. www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)

“To protect people, their microbiomes, and the effectiveness of antibiotics, this project is an example of applied research that has the potential to produce innovative public health approaches to better combat antibiotic resistance.”

Synthetic Biologics, Inc.  a clinical stage company focused on developing therapeutics to protect the gut microbiome while targeting pathogen-specific diseases, announced today it has been awarded a contract by the Centers for Disease Control and Prevention (CDC).

The award will support research conducted during the Company’s ongoing randomized, placebo-controlled Phase 2b proof-of-concept clinical study of SYN-004 (ribaxamase), designed to protect the gut microbiome from the unintended effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms.

“Antibiotics are life-saving medicines, but they also can disrupt a person’s microbiome and increase the risk for drug-resistant infections,” said Dr. Clifford McDonald, Associate Director of Science for CDC’s Division of Healthcare Quality Promotion. “To protect people, their microbiomes, and the effectiveness of antibiotics, this project is an example of applied research that has the potential to produce innovative public health approaches to better combat antibiotic resistance.”

The contract, awarded through the CDC’s Advanced and Innovative Solutions to Improve Public Health Broad Agency Announcement (BAA) 2016-N-17812, will support CDC’s efforts to assess how selective pressure from IV antibiotics may lead to the emergence of antibiotic resistance in the gut microbiome. The funding will also support research to evaluate ribaxamase’s ability to reduce selective pressure associated with the emergence of antibiotic-resistant organisms in the gut microbiomes of patients enrolled in the Company’s ongoing Phase 2b clinical trial. The Company will examine DNA isolated from longitudinal samples obtained during the clinical trial and look for changes to the patient’s gut resistome, specifically examining for alterations in the presence and/or abundance of antibiotic resistance genes.

“Synthetic Biologics is proud to have the support of the U.S. Government in its efforts to study the role of antibiotics in mediating resistance in the gut microbiome,” said Jeffrey Riley, President and Chief Executive Officer. “Ribaxamase’s strategy of degrading certain IV beta-lactam antibiotics before they are excreted into the GI tract has the potential to protect the gut microbiome from disruption by these antibiotics without inhibiting their ability to fight primary infections as well as mitigate conditions conducive to antibiotic-resistance development. We look forward to our collaboration with CDC and to furthering their initiative to assess and address rising global concerns for the proliferation of antibiotic resistance.”

 

To read the article in its entirety click on the following link:

http://ir.syntheticbiologics.com/press-releases/detail/221

 

European Patent Office Has Granted European Patent Which Provides Composition Of Matter Coverage For Synthetic Biologics’ ribaxamase

SyntheticBiologics2016LOGO

Synthetic Biologics; a clinical stage company focused on developing therapeutics to protect the gut microbiome announced on July 12, 2016  that the European Patent Office has granted European Patent No. 2576776 which provides composition of matter coverage for ribaxamase, the Company’s Phase 2 drug candidate designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of Clostridium difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms.

This is Synthetic Biologics’ first patent directly pertaining to ribaxamase in Europe and adds to the Company’s established and extensive patent estate.

In addition, the U.S. Patent and Trademark Office (USPTO) has granted
US Patent No. 9,376,673, and issued a Notice of Allowance for another application (US 15/160,669), with composition of matter claims for various beta-lactamase candidates related to ribaxamase. These new patent assets further strengthen the Company’s coverage of its novel proprietary candidate, ribaxamase, which is also covered by a previously granted composition of matter patent in the U.S.

“The successful granting of this composition of matter patent in Europe, alongside our continued patent successes in the U.S., further strengthens Synthetic Biologics’ role as a leader in the development of microbiome-focused programs intended to address largely unmet medical needs,” said Jeffrey Riley, President and Chief Executive Officer. “As we continue to enjoy momentum in the clinic, our progress is further complimented by our well established and reinforced patent estate for ribaxamase.”

Ribaxamase is designed to degrade certain intravenous (IV) beta-lactam antibiotics excreted into the gastrointestinal (GI) tract to maintain the natural balance of the
gut microbiome.

C. difficile is associated with approximately 453,000 CDIs and > 29,000 C. difficile-related deaths in the United States each year[i].

Upon issuance, these newly allowed applications reinforce Synthetic Biologics’ extensive C. difficile-related patent estate, which includes approximately 40 U.S. and foreign patents and approximately 30 U.S. and foreign patent pending applications, and patents and patent applications with terms that extend from at least 2031 to 2036.

 

To read this article in its entirety click on the link below:

http://ir.syntheticbiologics.com/press-releases/detail/216

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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