Last patient completes treatment in Motif Bio REVIVE-2 trial
MOTIF BIO
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08:30 29/07/20
Clinical stage biopharmaceutical company Motif Bio announced on Wednesday that the last patient had completed the treatment phase in REVIVE-2, its second Phase 3 clinical trial investigating the safety and efficacy of iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI).
The AIM-traded firm described REVIVE-2 as a 600-patient double-blinded, global, multicentre trial in patients with ABSSSI, that compared the safety and efficacy of an intravenous 80 mg dose of iclaprim with vancomycin also administered intravenously at a dose of 15mg/kg.
Treatments were administered every 12 hours for between five and 14 days, the board said, adding that REVIVE-2 followed the same protocol as REVIVE-1, which had completed with positive topline results announced on 18 April.
As in REVIVE-1, the primary endpoint of REVIVE-2 was “non-inferiority” 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 patient population.
Non-inferiority to a 10% margin at the test of cure endpoint, seven to 14 days after study drug discontinuation, in the ITT patient population was also being measured.
The top-line data from REVIVE-2 were expected during the fourth quarter of 2017.
“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,” said CEO Graham Lumsden.
“We thank the patients and investigators who participated in REVIVE-2.”
Successful results from the two REVIVE trials were 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 for iclaprim for the treatment of ABSSSI was anticipated in the first half of 2018.
“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,” Graham Lumsden added.
“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.”