Motif Bio plc (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced today that it has received the official meeting minutes from the U.S. Food and Drug Administration (FDA) guidance meeting which was held on 14 April 2015. The minutes confirm the FDA’s agreement with Motif’s Phase III clinical development programme for iclaprim, a broad-spectrum antibiotic designed to be effective against multi-drug resistant bacteria.
Iclaprim, a novel selective inhibitor of microbial dihydrofolate reductase (DHFR), is being developed as an intravenous (IV) formulation to treat acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP) caused by Gram positive pathogens, including resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA) and multi-drug resistant Streptococcus pneumoniae (MDRSP). The FDA has confirmed that two successful Phase III trials are required for the approval of iclaprim.
Graham Lumsden, CEO of Motif Bio plc, commented:
‘This FDA confirmation supports Motif moving forward to begin the iclaprim Phase III clinical programme. The trials will investigate the safety and efficacy of iclaprim in patients with ABSSSI and HABP, two serious and life threatening infections caused by multi-drug resistant bacteria. We believe that iclaprim may be an important addition in the fight against life threatening infections, a battle that is currently being lost to increasing antimicrobial resistance.’
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Notes to Editors:
Motif is a clinical stage biopharmaceutical company, which specialises in developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria. The Company has a lead antibiotic candidate, iclaprim, in clinical development and MTF-001, a preclinical stage programme to design a best-in-class dihydrofolate reductase inhibitor (DHFRi).
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 ) and MDRSP (multi-drug resistant Streptococcus pneumoniae ) that have become prevalent in patients in both the community and hospital settings.
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