25 April 2018 - - Rockville, Maryland-based late-stage clinical company Synthetic Biologics, Inc. (NYSE American: SYN) has preliminary agreement from the US Food and Drug Administration on a proposed clinical trial synopsis for its planned Phase 3 clinical trial for SYN-004 (ribaxamase),.
SYN-004 (ribaxamase) is designed to protect the gut microbiome from the effects of certain commonly used intravenous beta-lactam antibiotics for the prevention of C. difficile infection, overgrowth of pathogenic organisms and the emergence of antimicrobial resistance.
In accordance with recommendations and guidance received from the FDA, the company expects the Phase 3 trial to comprise a global, event-driven clinical trial with a fixed maximum number of patients for total enrollment, and to include separate co-primary endpoints designed to evaluate the efficacy and safety of ribaxamase in a patient population being treated with a representative selection of intravenous beta-lactam antibiotics.
The proposed Phase 3 study proposes to evaluate the potential efficacy and safety of ribaxamase in a broader patient population by the inclusion of additional IV beta-lactam antibiotics with ceftriaxone and by enrolling patients with a variety of underlying infections.
Based on a series of collaborative discussions with the FDA, the company expects the primary efficacy endpoint of the proposed Phase 3 clinical trial will be the reduction of the incidence of Clostridium difficile infection (CDI) in the ribaxamase treatment group relative to placebo.
The company also has preliminary agreement from the FDA to evaluate mortality risk as the primary safety endpoint for the trial, which will be separate from the primary efficacy endpoint of reduction of the incidence of CDI.
The designation of efficacy and safety as separate and decoupled endpoints is critical for clinical studies of this nature, where the underlying population is projected to have a comparatively high incidence of safety events that may significantly dilute the smaller number of CDI events.
Synthetic Biologics is developing therapeutics that preserve the microbiome to protect and restore the health of patients.
The company's lead candidates are: (1) SYN-004 (ribaxamase), and (2) SYN-010 The company's preclinical pursuits include an oral formulation of the enzyme intestinal alkaline phosphatase to treat both local GI and systemic diseases as well as monoclonal antibody therapies for the prevention and treatment of pertussis, and novel discovery stage biotherapeutics for the treatment of phenylketonuria.