Motif Bio, the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announces the dosing of the first patient in two Phase 3 clinical trials of its lead antibiotic candidate iclaprim, for the treatment of acute bacterial skin and skin structure infections (ABSSSIs).
The REVIVE ( R andomized E valuation Intra V enous I claprim V ancomycin Tr E atment) clinical trials will assess the efficacy and safety of iclaprim compared to a standard of care antibiotic, vancomycin, for the treatment of ABSSSIs. The two trials will be run by Covance and are global, multicentre, randomised, double-blind, Phase 3 studies evaluating a total of 1,200 adult patients who are hospitalised with ABSSSIs. The primary endpoint for the studies will be at least a 20 per cent reduction in lesion size at 48 to 72 hours after treatment. The key secondary endpoint is clinical cure at one to two weeks after treatment.
The successful completion of these two pivotal Phase 3 trials would satisfy both FDA and EMA requirements for regulatory approval. With the dosing of the first patient underway, both ABSSSI trials are expected to be completed in 2H17.
ABSSSI is a serious and life threatening infection caused by multi-drug resistant bacteria. The Phase 3 programme is designed to obtain marketing approval for an intravenous formulation of iclaprim for the treatment of ABSSSI.
Graham Lumsden, CEO of Motif Bio, stated: “This is an important milestone for Motif that keeps us on track to complete the trials in the second half 2017. Iclaprim has the potential to be a major addition to the armamentarium of antibiotics much needed for the treatment of serious and life-threatening infections caused by multi-drug resistant bacteria in hospitalised patients.