Date: 2014-08-05
Type of information: Services contract
Compound: formulation services for SYN-004
Company: Synthetic Biologics (USA - MD) Evonik (Germany)
Therapeutic area: Technology - Services - Infectious diseases
Type agreement: collaboration services
Action mechanism: SYN-004 is designed as the first prophylactic treatment intended to prevent the development of Clostridium 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).
Disease: prevention of Clostridium difficile infections
Details: * On August 5, 2014, Synthetic Biologics, a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, announced that 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 Limited. 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.
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