Motif Bio plc (AIM:MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced today that it has received written advice from a Scientific Advice Meeting with the Medicines Evaluation Board (MEB) in Utrecht, The Netherlands, held on 16 September 2015, in relation to the Phase III Clinical Development Programme for iclaprim.
The MEB’s advice confirms that two Phase III clinical trials plus microbiological data derived from the planned surveillance studies, are acceptable as pivotal registration studies for approval in the European Union through the “centralized” regulatory procedure of intravenous iclaprim, a targeted spectrum antibiotic designed to be effective against multi-drug-resistant bacteria, including MRSA.
Dr. David Huang, Chief Medical Officer at Motif, said: “With MEB acceptance of our proposal for two Phase III clinical trials for iclaprim, Motif remains firmly on track to meet its goal of completing the two ABSSSI trials in 2017, and submitting a Marketing Authorisation Approval in Europe.”
Motif Bio plc
Graham Lumsden, Chief Executive Officer
David Huang, Chief Medical Officer
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Notes to Editors
Motif is a clinical-stage biopharmaceutical company, specialising in the development of novel antibiotics that are designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of the most common and serious bacterial infections such as acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including those caused by resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus). Two Phase III ABSSSI clinical trials are on track to be completed in 2017 and if approved, iclaprim could be ready for commercialization in 2018. The Company is in discussions with pharmaceutical companies and universities to build a pipeline of innovative antibiotics targeting Gram-positive and Gram-negative bacteria. For additional information about Motif please visit www.motifbio.com.