Motif Bio plc (LON:MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced today that the last patient has completed the treatment phase in REVIVE-2, the second Phase 3 clinical trial investigating the safety and efficacy of iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI).
REVIVE-2 is a 600-patient double-blinded, global, multicentre trial in patients with ABSSSI that compares the safety and efficacy of an intravenous 80mg dose of iclaprim with vancomycin also administered intravenously at a dose of 15mg/kg. Treatments were administered every 12 hours for 5 to 14 days. REVIVE-2 followed the same protocol as REVIVE-1, which has completed with positive topline results announced on 18 April 2017. As in REVIVE-1, the primary endpoint of REVIVE-2 is non-inferiority (10% margin) compared to vancomycin at the early time point, 48 to 72 hours after the start of administration of the study drug, in the intent-to-treat (ITT) patient population. Non-inferiority (10% margin) at the test of cure endpoint, 7 to 14 days after study drug discontinuation, in the ITT patient population will also be measured. The top-line data from REVIVE-2 are expected during the fourth quarter of 2017.
Successful results from the two REVIVE trials are expected to satisfy both US FDA and EMA requirements for regulatory submission for intravenous iclaprim in the treatment of ABSSSI. Submission of a New Drug Application (NDA) for iclaprim for the treatment of ABSSSI is anticipated in the first half of 2018.
Graham Lumsden, CEO of Motif Bio Plc, commented: “The last patient treated in our REVIVE-2 trial is another key milestone for the Company that keeps us on track to be able to submit an NDA next year. We thank the patients and investigators who participated in REVIVE-2. We believe that iclaprim, if approved, could be an important option for hospitalised patients with ABSSSI, especially for those patients who also have kidney disease with or without diabetes. Unlike current standard of care antibiotics, in clinical trials to date, nephrotoxicity has not been observed with iclaprim and dosage adjustment has not been required in renally impaired patients. It is estimated that up to 26% of the 3.6 million ABSSSI patients hospitalised annually in the U.S. have kidney disease.”