Tag Archives: C diff prevention clinical study

The United States Adopted Names Council (USAN) Of the American Medical Association Has Approved the Use Of “ribaxamase” For Synthetic Biologics’ SYN-004 For the Prevention Of C. difficile Infection (CDI)

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The United States Adopted Names Council (USAN) of the American Medical Association has approved the use of “ribaxamase” (Rye-bak’-sa-mase) for Synthetic Biologics’ SYN-004.

Ribaxamase is the Company’s Phase 2 development candidate 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.

Synthetic Biologics recently reported positive results from two Phase 2a clinical trials demonstrating a correlation of the 150 mg dose of ribaxamase with the degradation of residual IV ceftriaxone alone, and in the presence of the proton pump inhibitor (PPI), esomeprazole, to levels that were near or below detectable in the intestinal chyme of healthy participants with functioning ileostomies. A Phase 2b proof-of-concept, randomized, placebo-controlled clinical trial is currently underway to evaluate the ability of ribaxamase to prevent CDI and AAD in patients hospitalized with a lower respiratory tract infection and receiving IV ceftriaxone. An interim analysis of blinded data performed by an independent data monitoring committee is expected in summer of 2016.

“The approval of the generic name ribaxamase for SYN-004 by USAN is a defining milestone for Synthetic Biologics. Ribaxamase represents a newly created and innovative first-in-class drug designed to protect the naturally occurring gut microbiome from the unintended consequences of antibiotic use,” said Jeffrey Riley, President and Chief Executive Officer. “By degrading certain IV beta-lactam antibiotics before they reach the gastrointestinal (GI) tract, ribaxamase may not only prevent the onset of CDI and AAD, but has the potential to be an instrumental tool for preventing the emergence of antibiotic resistance in organisms which comprise the gut microbiome. We are excited for the continued clinical development of ribaxamase and look forward to sharing our progress including announcing results from our ongoing global Phase 2b proof-of-concept clinical trial.”

 

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

http://www.syntheticbiologics.com/news-media/press-releases/detail/215/synthetic-biologics-receives-usan-approval-for-generic-name

Synthetic Biologics SYN-004 Intended for the Prevention of C. diff. Infection (CDI) and Antibiotic-Associated Diarrhea (AAD)

UPDATE:

Synthetic Biologics Announces Further U.S. Patent Successes Covering SYN-004 Intended for the Prevention of C. difficile Infection and Antibiotic-Associated Diarrhea

 

Synthetic Biologics, Inc. a clinical stage company focused on developing therapeutics to protect the gut microbiome, announced today that the U.S. Patent and Trademark Office (USPTO) issued Notices of Allowance for three patent applications which cover composition of matter claims and methods of protecting the gut microbiome from certain beta-lactam antibiotics for the prevention of C. difficile infection (CDI) and antibiotic-associated diarrhea (AAD). These new allowances further strengthen the Company’s novel proprietary candidate, SYN-004, which is also covered by a composition of matter patent in the U.S.

 

 Synthetic Biologics, Inc. www.syntheticbiologics.com

What is SYN-004? 

SYN-004  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 35 U.S. and foreign patents and approximately 30 U.S. and foreign patent applications, and carry patent terms that extend from at least 2031 to 2035.

“These new patents will complement our growing SYN-004 patent estate and support our C. difficile prevention program, including two ongoing Phase 2 clinical trials,” said Jeffrey Riley, President and Chief Executive Officer of Synthetic Biologics. “We’re on schedule with respect to patient enrollment in our global Phase 2b proof-of-concept clinical trial intended to evaluate the ability of SYN-004 to prevent CDI and AAD in patients hospitalized with a lower-respiratory tract infection. During the first half of 2016, we also anticipate announcing topline data from the second Phase 2a clinical trial which is evaluating the ability of SYN-004 to degrade IV ceftriaxone in the presence of a proton pump inhibitor.”

About Synthetic Biologics, Inc. For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

C. diff. Spores and More – CdiffRadio – Welcomes Guests; Dr. Guy de Bruyn,MD, Dr. Christian Felter,MD, and Dr. Patricia J. Pietrobon,Ph.D. of Sanofi Pasteur

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Join us on Tuesday, March 1st as we discuss ——-

C. diff. Vaccine Update; Sanofi Pasteur’s Cdiffense”

Tuesday, March 1st — Live Broadcast Times

10 a.m. Pacific Time,,   11 a.m. Mountain Time,
12 p.m. Central Time,    1 p.m. Eastern Time

We invite you to  listen to the live broadcast and archived programs by clicking on the
Cdiff radio logo displayed below:

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This episode we will introduce  Sanofi Pasteur, one of the leading vaccine manufacturers in the world, is in the midst of its Phase III clinical trial called Cdiffense to study its investigational vaccine to prevent Clostridium difficile infection (CDI).

The trial is now in more than 20 countries across 5 continents to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary, symptomatic CDI.

The investigational C. diff vaccine is designed to produce an immune response that targets the toxins generated by C. diff bacteria, which can cause inflammation of the gut. The investigative vaccine ultimately may help prevent a future infection from occurring. Volunteers for the study should be age 50 or older and planning an upcoming hospitalization or have had at least two hospital stays and have received systemic antibiotics in the past year.

For more information on the Cdiffense trial – Please visit www.Cdiffense.org 

Join Guests: 
Dr. Guy de Bruyn, MD  –  Director for Clinical Development at Sanofi Pasteur, overseeing a large phase III vaccine trial for the prevention of Clostridium difficile infection in some 19 countries on 5 continents around the world that started in the U.S. in 2013.

Dr. Christian Felter, MD  –  Associate VP, Global Medical Expert for Nosocomial Vaccines for Sanofi Pasteur based in Lyon, France. His focus is on their investigative Clostridium difficile vaccine. Dr. Felter has 11 years of experience in medical affairs roles in the US and Europe, covering therapeutic areas including Immunology, Rheumatology, and Infectious Diseases.

Dr. Patricia J. Freda Pietrobon, PhD  – Associate Vice President, Research & Development Sanofi Pasteur Dr. Patricia J. Freda Pietrobon, PhD, Associate Vice President, R&D, Sanofi Pasteur, has over 25 years of experience in the Vaccine & Diagnostic industries and more then 20 years in leadership roles focusing on research & development of new vaccines.

Join us as we introduce Sanofi Pasteur and discuss updates focused on

C. diff. Vaccine Update; Sanofi Pasteur’s Cdiffense

C. diff. Spores and More™  Global Broadcasting Network –  producing educational programs dedicated to  C. difficile Infections and more —  brought to you by VoiceAmerica and sponsored by Clorox Healthcare

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.