Date: 2014-08-05
Type of
information: Results
phase: 1
Announcement: results
Company: Synthetic Biologics (USA - MD)
Product: SYN-004
Action
mechanism:
- SYN-004 is designed as the first 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).
Disease: prevention of Clostridium difficile infections
Therapeutic
area: Infectious diseases
Country:
Trial
details:
Latest
news:
- • On March 19, 2015, Synthetic Biologics, a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, announced positive pharmacokinetics (PK) results from both the Phase 1a and 1b studies of SYN-004, which is being developed to protect the microbiome and prevent Clostridium difficile (C. difficile) infection. The Phase 1a, single-ascending dose PK study provided data to support Synthetic Biologics' hypothesis that SYN-004 taken orally was not systemically available in the dose range tested. The PK data from this study measured blood levels of a single dose of SYN-004 in participants over a 10-fold dose range. Minimal levels of SYN-004 were observed in the bloodstream across the dose range investigated in the participants. The Phase 1b, multiple-ascending dose PK study provided data to further support that SYN-004 is not systemically available, as no meaningful levels of SYN-004 were observed in the bloodstream after participants received multiple doses of SYN-004 four times a day over a seven-day period. The PK data confirm Synthetic Biologics' expectations based on previous data from the first generation enzyme (P1A). In addition, no clinically significant safety events were observed, and both the single and multiple doses of SYN-004 were well tolerated by the participants of the Phase 1 studies. Synthetic Biologics intends to continue the clinical development of SYN-004 in a Phase 2a clinical trial to evaluate the ability of SYN-004 to degrade residual IV antibiotic in the gastrointestinal (GI) tract, therefore potentially protecting the gut microbiome and preventing C. difficile infection.
- • 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, with a new multi-service agreement in place, the Company is on track to initiate Phase Ia and Ib 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. 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 Ia and Ib clinical studies in the fourth quarter of 2014. Preliminary Phase I topline data is expected by year-end 2014, and a Phase II efficacy study of SYN-004 is planned to begin in the first half of 2015.
- Last June, Synthetic Biologics has entered into an agreement with the French company Enterome Bioscience to conduct metagenomic research on the effects of beta-lactam antibiotics on the microbiome of human patients. The goal is to establish a “fingerprint” of the damage caused by beta-lactam antibiotics, thus yielding a panel of bacterial biomarkers that can be leveraged for diagnostic purposes.
Is
general: Yes
