23 April 2018 - Synthetic Biologics today announced that it has preliminary agreement from the U.S. FDA on a proposed clinical trial synopsis for its planned Phase 3 clinical trial for SYN-004 (ribaxamase). 

In accordance with recommendations and guidance received from the FDA, the company expects the Phase 3 trial 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 (IV) beta-lactam antibiotics.

Synthetic Biologics further announced that during the development of the proposed Phase 3 clinical trial, the FDA undertook an additional review of data and analysis submitted by the Company from the previously completed ribaxamase Phase 2b clinical trial. Following FDA's review of the additional data, it was determined that the requirements for breakthrough therapy designation were no longer met due to the numerical imbalance in fatal adverse events observed in the study which could not be fully evaluated due to the limited safety database, and the study's method of statistical treatment of patients who did not complete the study for any reason.

Read Synthetic Biologics press release