April 23, 2018 / 11:32 AM / 7 months ago

BRIEF-Synthetic Biologics Provides Update On Development Of Syn-004 (Ribaxamase

April 23 (Reuters) - Synthetic Biologics Inc:

* SYNTHETIC BIOLOGICS PROVIDES UPDATE ON DEVELOPMENT OF SYN-004 (RIBAXAMASE), FOR THE PREVENTION OF C. DIFFICILE INFECTION

* SYNTHETIC BIOLOGICS - HAS PRELIMINARY AGREEMENT FROM FDA, ON A PROPOSED CLINICAL TRIAL SYNOPSIS FOR ITS PLANNED PHASE 3 CLINICAL TRIAL FOR SYN-004

* SYNTHETIC BIOLOGICS - HAS PRELIMINARY AGREEMENT FROM FDA TO EVALUATE MORTALITY RISK AS PRIMARY SAFETY ENDPOINT FOR PHASE 3 TRIAL OF SYN-004

* SYNTHETIC BIOLOGICS- IN ACCORDANCE WITH RECOMMENDATIONS, GUIDANCE FROM FDA, CO EXPECTS SYN-004 PHASE 3 TRIAL TO INCLUDE SEPARATE CO-PRIMARY ENDPOINTS

* SYNTHETIC BIOLOGICS - FDA UNDERTOOK ADDITIONAL REVIEW OF DATA & ANALYSIS SUBMITTED BY CO FROM PREVIOUSLY COMPLETED RIBAXAMASE PHASE 2B CLINICAL TRIAL

* SYNTHETIC BIOLOGICS - FDA’S REVIEW OF ADDITIONAL RIBAXAMASE PHASE 2B TRIAL DATA SHOWED REQUIREMENTS FOR BREAKTHROUGH THERAPY DESIGNATION WERE NO LONGER MET

* SYNTHETIC BIOLOGICS - HAS VOLUNTARILY WITHDRAWN BREAKTHROUGH THERAPY DESIGNATION FOR RIBAXAMASE PROGRAM Source text for Eikon: Further company coverage:

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