A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI

Phase 2 Completed 413 enrolled Theriva Biologics, Inc.

RandomizedParallel-groupDouble-blindPrevention

Summary

A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract Infection (LRTI).

Timeline

Start: 2015-10
Primary completion: 2016-11
Completion: 2016-11

Outcome

Met primary endpoint

registry analysis (other test); SYN-004 vs Placebo; p = 0.045; Relative Risk Reduction (%) 71.4 (95% CI -35.9 to 94.0); z-test NCT02563106 ↗

release “synthetic-biologics-syn-004-ribaxamase-achieves-primary-endpoint-in-phase-2b-trial-for-c-difficile-infection-cdi” therivabio.com ↗

release “the successful Phase 2b clinical trial of ribaxamase, which met its primary endpoint of significantly reducing CDI.” therivabio.com ↗

Publications

Kokai-Kun JF, Roberts T, Coughlin O, Le C, Whalen H, Stevenson R, Wacher VJ, Sliman J. Use of ribaxamase (SYN-004), a beta-lactamase, to prevent Clostridium difficile infection in beta-lactam-treated patients: a double-blind, phase 2b, randomised placebo-controlled trial. Lancet Infect Dis. 2019 May;19(5):487-496. doi: 10.1016/S1473-3099(18)30731-X. Epub 2019 Mar 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ribaxamase	Monoclonal antibody	150 mg	Oral