Synthetic Biologics Inc., a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, announced that, with a new multi-service agreement in place, the company is on track to initiate Phase 1a and 1b clinical trials of SYN-004 for the prevention of Clostridium difficile (C. difficile) during the fourth quarter of 2014. The company has entered into an agreement with Evonik for oral formulation development, analytical services, and clinical drug manufacturing in accordance to GMP guidelines, of the company’s proprietary oral beta-lactamase enzyme, SYN-004, for use in the planned clinical trials. Evonik plans to formulate and encapsulate enterically coated SYN-004 for oral delivery using material generated by Synthetic Biologics’ API manufacturer Fujifilm Diosynth Biotechnologies UK Ltd.

 

SYN-004 is designed as the first and only prophylactic treatment intended to prevent the development of C. difficile infections, by binding with and neutralizing certain intravenous (IV) beta-lactam antibiotics in the gut. SYN-004 is intended to block the effects of antibiotics within the gastrointestinal tract, maintaining the natural balance of bacterial flora (the gut microbiome), potentially preventing the 1.1 million C. difficile infections in the U.S. each year.

 

“SYN-004 has the potential to have a significant impact on mitigating the effects of C. difficile, a major public health issue, and we are thrilled to be advancing rapidly toward the clinic with our novel and differentiated approach,” stated Jeffrey Riley, chief executive officer of Synthetic Biologics. “While we await the topline results of the ongoing toxicology study, we are pleased to have begun working with our strategic partner Evonik, to optimize formulation variables and manufacture GMP clinical trial drug supply to support our planned human studies, once our IND is in place.”

 

The U.S. Centers for Disease Control and Prevention (CDC) has classified harmful and potentially deadly C. difficile as an “urgent public health threat,” surpassing methicillin-resistant Staphylococcus aureus (MRSA) as the number one hospital-acquired infection in the United States.

 

Prior to initiating cGMP manufacturing of SYN-004 capsules, Evonik successfully formulated and manufactured nonclinical trial material for the ongoing canine toxicology study, from which Synthetic Biologics expects to report topline results next month. With these critical milestones underway, the company remains on schedule to file an Investigational New Drug (IND) application for SYN-004, and intends to initiate Phase 1a and 1b clinical studies in the fourth quarter of 2014. Preliminary Phase 1 topline data is expected by year-end 2014, and a Phase 2 efficacy study of SYN-004 is planned to begin in the first half of 2015.

 

Date: August 5, 2014

Source: Synthetic Biologics