Synthetic Biologics Initiates Manufacturing of SYN-004 for Use in Preclinical and Clinical Trials
News Oct 17, 2013
Synthetic Biologics, Inc. has announced the successful completion of the protein expression evaluation with regard to the Company's proprietary oral beta-lactamase enzyme (SYN-004) targeting the prevention of Clostridium difficile (C. difficile or C. diff) infections, America's most prevalent hospital-acquired bacterial infection.
FUJIFILM Diosynth Biotechnologies UK Limited (Fujifilm) has analyzed and demonstrated a greater than 20-fold improvement in SYN-004 expression titers with consistent biological activity utilizing its pAVEway™ platform (an E. coli system) compared to the Bacillus platform previously employed by Ipsat Therapeutics Oy (Finland) for the expression of P1A, a first-generation candidate of SYN-004.
Pursuant to an agreement entered into with Fujifilm on October 8th, manufacturing of SYN-004 material to support Synthetic Biologics' planned preclinical and clinical studies is underway.
SYN-004, a novel second-generation oral drug candidate in preclinical development for co-administration with commonly used IV antibiotics, is intended to prevent the development of severe effects of C. diff infection, which is extremely harmful and potentially deadly.
Designed to be given orally to protect the gut flora (microbiome) while certain IV beta-lactam antibiotics (penicillins and cephalosporins) fight the primary infection, SYN-004 is believed to have a similar profile to its first-generation predecessor, which demonstrated favorable protection of the gut flora during treatment with certain penicillins, with the potential to act against a broader spectrum of IV beta-lactam antibiotics.
"We're very excited to be working with the dedicated team at Fujifilm. With the SYN-004 production cell line evaluation and selection of the E. coli expression clone successfully completed, we have initiated manufacturing of preclinical material for animal studies and cGMP production of SYN-004 for clinical trials," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics.
Riley continued, "We are pleased that these efforts move us closer toward our goal of developing a prophylactic to prevent the devastating effects of C. diff infections, for which there is currently no other approved preventive therapy. We look forward to announcing the initiation of preclinical studies during the first half of 2014, after which we plan to initiate our clinical trials."
Steve Bagshaw, Managing Director of Fujifilm Diosynth Biotechnologies UK Limited said, "We are delighted that the pAVEway™ study performed in our R&D laboratories has produced such a successful improvement in titers. We now look forward to performing further process optimization before scaling up in our pilot scale laboratories and ultimately producing cGMP material to allow Synthetic Biologics to carry out clinical trials in the fight to provide a drug to counteract the effects of C. difficile infections."