Motif BioSciences, Inc. Phase 3 Clinical Trial Finishes Patient Treatment Phase
Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the last patient has finished the treatment phase in REVIVE-1, the Phase 3 clinical trial investigating the safety and efficacy of iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI).
REVIVE-1 is a 600-patient double-blinded, global, multicentre trial, in patients with ABSSSI that compares the safety and efficacy of an 80mg intravenous dose of iclaprim with 15mg/kg intravenous vancomycin. Treatments were administered every 12 hours for 5 to 14 days. Data read-out is expected in the second quarter of 2017.
Data read-out for REVIVE-2 is anticipated in the second half of 2017. Successful completion of the two REVIVE trials is expected to satisfy both US FDA and EMA requirements for regulatory submission for intravenous iclaprim in the treatment of ABSSSI.
Commenting on this milestone, Graham Lumsden, CEO of Motif Bio, said: “Thanks to the patients and investigators who participated in REVIVE-1, we remain on track to be able to share the first data from our Phase 3 clinical trials in Q2 17. We believe that iclaprim, if approved, can be an important option for patients hospitalised with ABSSSI who 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.”
REVIVE-1 is a 600-patient double-blinded, global, multicentre trial, in patients with ABSSSI that compares the safety and efficacy of an 80mg intravenous dose of iclaprim with 15mg/kg intravenous vancomycin. Treatments were administered every 12 hours for 5 to 14 days. Data read-out is expected in the second quarter of 2017.
Data read-out for REVIVE-2 is anticipated in the second half of 2017. Successful completion of the two REVIVE trials is expected to satisfy both US FDA and EMA requirements for regulatory submission for intravenous iclaprim in the treatment of ABSSSI.
Commenting on this milestone, Graham Lumsden, CEO of Motif Bio, said: “Thanks to the patients and investigators who participated in REVIVE-1, we remain on track to be able to share the first data from our Phase 3 clinical trials in Q2 17. We believe that iclaprim, if approved, can be an important option for patients hospitalised with ABSSSI who 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.”