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Motif Bio’s iclaprim meets primary endpoint in second phase 3 ABSSI trial

UK-based Motif Bio reported that its skin disorder drug iclaprim has succeeded in a second phase 3 trial in patients with acute bacterial skin and skin structure infections (ABSSSI).
Iclaprim, which is a diaminopyrimidine antibiotic, met its primary endpoint and was found to be well tolerated during the phase 3 clinical trial dubbed REVIVE-2.
Featuring 600 ABSSSI patients, the late-stage global trial evaluated the safety and efficacy of iclaprim at 80mg given intravenously in comparison to 15mg/kg intravenous dose of vancomycin, the current standard of care for the disease.
The primary endpoint of the trial was met by iclaprim when it achieved non-inferiority (10% margin) in comparison to vancomycin. It was achieved in the intent-to-treat (ITT) patient population, at the early time point (ETP), 48 to 72 hours after the drug was given.
In the same patient population, iclaprim achieved non-inferiority (10% margin) at the test of cure (TOC) endpoint, 7 to 14 days after its discontinuation.
Iclaprim also achieved a clinical cure of 72% in patients, which was 1.37% more than patients who were subjected to vanomycin.
Motif Bio CEO Graham Lumsden said: “We believe that iclaprim, if approved, could be an important option for patients with ABSSSI, especially for those patients who may also have kidney disease, with or without diabetes.
“It is estimated that up to 26% of the 3.6 million ABSSSI patients hospitalised annually in the U.S. have kidney disease. 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.”
In mid-April, Motif Bio reported that iclaprim succeeded in REVIVE-1, which was also a phase 3 trial held in ABSSSI patients.
Having achieved positive topline results from REVIVE-1 and REVIVE-2, Motif Bio plans to submit an NDA to the US FDA by the end of the Q1 2018.