Synthetic Biologics and partner Fujifilm Diosynth Biotechnologies have completed the protein expression evaluation of Synthetic Biologics’ oral beta-lactamase enzyme (SYN-004) targeting Clostridium difficile infections. Fujifilm analyzed and demonstrated a greater than 20-fold improvement in SYN-004 expression titers using its pAVEway platform (an E. coli system) compared to the Bacillus platform previously used. Fujifilm will manufacture SYN-004 material to support Synthetic Biologics' planned preclinical and clinical studies.
SYN-004 is a second-generation oral drug candidate in preclinical development for co-administration with commonly used IV antibiotics, and is intended to prevent the development of severe effects of C. diff infection.
"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," said Jeffrey Riley, chief executive officer of Synthetic Biologics. "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 Ltd. 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."