REVIVE-2, a global Phase III clinical trial has success in evaluating iclaprim in patients with acute bacterial skin and skin structure infections.- Motif Bio.

Motif Bio plc announced positive topline results from REVIVE-2, a global Phase III clinical trial evaluating the investigational drug candidate iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI). Iclaprim achieved the primary endpoint of non-inferiority (NI) (10% margin) compared to vancomycin, the current standard of care, at the early time point (ETP), 48 to 72 hours after the start of administration of the study drug, in the intent-to-treat (ITT) patient population.

Iclaprim also achieved NI (10% margin) at the test of cure (TOC) endpoint, 7 to 14 days after study drug discontinuation, in the ITT patient population.

The company aims to differentiate iclaprim through its favorable side-effect profile, particularly on the kidneys.Unlike current standard of care antibiotics, in clinical trials to date, kidney toxicity has not been observed with iclaprim and dosage adjustment has not been required in patients with renal impairment. Vancomycin is not recommended to treat infections in patients who are renally impaired, and the company estimates that up to 26% of the 3.6 million ABSSSI patients hospitalized each year have kidney disease.