NEWS & MEDIA
Motif Bio plc – Phase 3 Clinical Trial Update31 January 2017
Motif Bio plc
(“Motif Bio” or the “Company”)
Motif Bio 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.”
For further information, please contact:
Motif Bio plc
Graham Lumsden (Chief Executive Officer): email@example.com
Zeus Capital Limited (NOMAD & BROKER)
Phil Walker/Giles Balleny/Dominic Wilson: +44 (0)20 3829 5000
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Raimund Gabriel: +49 (0)89 210 2280
Notes to Editors:
About Iclaprim: Iclaprim is a novel antibiotic that has a different and underutilized mechanism of action compared to most 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 600 patients and healthy volunteers.
About Motif Bio: Motif Bio 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. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), hospital infections often caused by MRSA (methicillin resistant Staphylococcus aureus).
This information is provided by RNS
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