Motif Bio plc ,the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced 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, 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.”
Motif Bio plc firstname.lastname@example.org
Graham Lumsden (Chief Executive Officer)
Robert Dickey IV (Chief Financial Officer)
Peel Hunt LLP (NOMAD & BROKER) + 44 (0)20 7418 8900
Dr Christopher Golden
Northland Capital Partners Limited (BROKER) +44 (0)203 861 6625
Patrick Claridge/ David Hignell
John Howes/ Rob Rees (Broking)
Iclaprim is a novel antibiotic that has a different and underutilised mechanism of action compared to other antibiotics. Iclaprim exhibits potent activity against Gram-positive clinical isolates of many genera of staphylococci, including methicillin resistant Staphylococcus aureus (MRSA). Iclaprim is rapidly bactericidal, achieving 99.9% in-vitro kill against MRSA within 4 to 6 hours of drug exposure versus 8 to 10 hours for vancomycin. To date, iclaprim has been studied in over 1,300 patients and healthy volunteers. Iclaprim is administered intravenously at a fixed dose with no dosage adjustment required in patients with renal impairment, or in obese patients. The iclaprim fixed dose may help reduce the resources required in hospitals since dosage adjustment by health care professionals is avoided and overall hospital treatment costs may be lower, especially in renally impaired patients.
About Motif Bio
Motif Bio plc is a clinical-stage biopharmaceutical company, engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalised patients caused by multi-drug resistant bacteria, including MRSA (methicillin-resistant Staphylococcus aureus). The Company’s lead product candidate, iclaprim, is being developed for high risk MRSA patient populations. The first proposed indication, and near-term commercial opportunity, is for the treatment of acute bacterial skin and skin structure infections (ABSSSI), one of the most common bacterial infections, with 3.6 million patients hospitalised annually in the U. S. The Company believes that iclaprim is suitable for first-line empiric therapy in ABSSSI patients, especially those with renal impairment, with or without diabetes, due to its underutilised mechanism of action, targeted spectrum of activity, low propensity for resistance development, fixed dose administration, clearance of inactive metabolites through the kidneys and favourable tolerability profile.