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Blog Coverage: Synthetic Biologics Wins Breakthrough Therapy Designation for its Clostridium Difficile Infection Candidate

Upcoming AWS Coverage on Corcept Therapeutics Post-Earnings Results

LONDON, UK / ACCESSWIRE / May 12, 2017 / Active Wall St. blog coverage looks at the headline from Synthetic Biologics, Inc. (NYSE: SYN) as the late-stage clinical Company, which develops therapeutics that preserve the microbiome, announced on May 11, 2017, that it has received the Breakthrough Therapy Designation from US Food and Drug Administration (FDA) for SYN-004 (ribaxamase) for the prevention of Clostridium difficile infection (CDI). Register with us now for your free membership and blog access at:


One of Synthetic Biologics' competitors within the Biotechnology space, Corcept Therapeutics Inc. (NASDAQ: CORT), reported on May 01, 2017, its financial results for the quarter ended March 31, 2017. AWS will be initiating a research report on Corcept Therapeutics in the coming days.

Today, AWS is promoting its blog coverage on SYN; touching on CORT. Get all of our free blog coverage and more by clicking on the link below:


Approval Details

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 Company stated that the FDA granted Breakthrough Therapy Designation based on data from the successful Phase 2b clinical trial of ribaxamase, which met its primary endpoint of significantly reducing CDI.

Synthetic Biologics initiated a Phase 2b proof-of-concept clinical trial intended to evaluate the effectiveness of ribaxamase to prevent the onset of primary CD), antibiotic-associated diarrhea (AAD) and the emergence of antimicrobial resistance (AMR) in patients hospitalized with a lower respiratory infection and receiving IV ceftriaxone. Results from this trial indicated that patients receiving ribaxamase achieved a 71.4% relative risk reduction in CDI rates compared to patients receiving placebo. Analysis of the data also demonstrated a significant reduction in new colonization by vancomycin-resistant enterococci (VRE) for patients receiving ribaxamase compared to placebo.

FDA Breakthrough Therapy Designation is considered to be significant as it can 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 CDI 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."

What is Clostridium Difficile Infection?

As per the official press release, clostridium difficile infection often referred as C. diff is the biggest hospital acquired infection in the US, with more than 453,000 patients diagnosed annually. CDI results in approximately 29,000 deaths, $1.5 billion in additional healthcare costs, as well as significant and sometimes prolonged illness.

Stock Performance

At the close of trading session on Thursday, May 11, 2017, following the announcement, Synthetic Biologics' stock price surged 28.53% to end the day at $0.55. A total volume of 10.45 million shares were exchanged during the session, which was above the 3-month average volume of 827.87 thousand shares. The stock currently has a market cap of $65.02 million.

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