C. difficile Infection Prevention; Synthetic Biologics Announces First Patient Dosed in Phase 1a Clinical Trial of SYN-004

Synthetic Biologics Announces First Patient Dosed in Phase 1a Clinical Trial of SYN-004
for the Prevention of C. difficile Infection
First-in-Class Clinical Program Targets Protection of Microbiome to Prevent Overgrowth of deadly C. difficile Infection Linked with Use of IV Antibiotics
Rockville, MD, December 2, 2014 – Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced that enrollment has initiated and the first patient was dosed in a Phase 1a clinical trial of SYN-004, an investigational oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infection (CDI), antibiotic-associated diarrhea (AAD) and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy.

The randomized, double-blind, placebo-controlled Phase 1a study, which is now underway at Clinical Pharmacology of Miami, is designed to evaluate the safety, tolerability and pharmacokinetics of five single ascending doses of oral SYN-004 in healthy volunteers.

In all, up to 40 healthy adult volunteers will be enrolled into five cohorts, with approximately six participants receiving SYN-004 and two receiving placebo in each cohort. Before the end of the year, top line Phase 1 data is expected to be reported and a Phase 1b study evaluating multiple-ascending doses of SYN-004 is planned to begin.

“The initiation of the clinical program for SYN-004 represents an important milestone for Synthetic Biologics and a key step towards the first potential point-of-care preventative therapy for C. difficile, the CDC’s top-ranking public health threat,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “We look forward to moving Synthetic Biologics’ innovative therapeutic approach to prevent C. difficile infection through
clinical development, and further validating the connection between protecting the gut microbiome and a variety of GI, metabolic and CNS disorders.”

Currently, there is no vaccine or drug approved by the U.S. Food and Drug Administration (FDA) specifically for the prevention of C. difficile infection, which the U.S. Centers for Disease Control (CDC) has identified as an “urgent public health threat” and occurs mostly in people who have had recent medical care with IV antibiotics. These antibiotics can create a harmful imbalance in the gut microbiome by killing “good” bacteria, giving C. difficile a chance to multiply and cause diarrhea, which can lead to dehydration, fever, abdominal
pain, cramping, nausea, colitis, and even death.

In all, 24 million Americans receive IV antibiotics annually.
SYN-004 is Synthetic Biologics’ oral drug candidate designed to be the first and only treatment intended to prevent the development of C. difficile infection, by binding with and neutralizing certain common IV betalactam antibiotics in the gut.

For further information, please contact:
Synthetic Biologics:  Kris Maly, VP, Corporate Communication, (734) 332-7800, info@syntheticbiologics.com

i This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.
ii This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.
iii This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

iv U.S. Department of Health & Human Services. Agency for Healthcare

 

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