Motif Bio plc (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced today that its wholly-owned subsidiary, Motif BioSciences Inc., has signed Letters of Intent (LOIs) and interim agreements with a leading global Clinical Research Organisation (CRO). Under the terms of these interim agreements, the CRO will undertake preparations for two Phase III, randomised, double-blind, multicenter clinical trials to evaluate the efficacy and safety of intravenous iclaprim versus vancomycin in the treatment of acute bacterial skin and skin structure infections (“ABSSSIs”) suspected or confirmed to be due to Gram-positive pathogens.
Iclaprim is a broad-spectrum antibiotic designed to be effective against multi-drug resistant bacteria. Motif is investing over US$950,000 under the terms of the interim agreements, to be paid by 31 July 2015. Pursuant to the LOIs, the parties will negotiate the terms and conditions of a mutually acceptable formal agreement for the conduct of the two studies.
The selected CRO is one of the world’s top five providers of Phase I-IV clinical trial management services and to date, has contributed to the development of all of the top 50 prescription medicines on the market. The CRO has unique insights into infectious disease clinical trials with over 17,000 patients in more than 150 studies.
Graham Lumsden, CEO of Motif Bio plc, commented:
“Retaining this leading global CRO is the first major step for Motif in achieving our goal of successfully completing Phase III clinical trials with iclaprim. The safety and efficacy of this broad spectrum antibiotic has already been proven in many patients, and we believe that iclaprim may be an important treatment option for ABSSSIs. Combining the knowledge and experience of Motif’s management and directors with the infectious diseases expertise of our selected CRO is expected to add tremendous value for our investors.”
Motif Bio plc
Graham Lumsden, Chief Executive Officer
Robert Bertoldi, Chief Financial Officer
Zeus Capital Limited (Nominated Advisor and Broker)
Phil Walker / Dan Bate
+44 (0) 20 3829 5000
Northland Capital Partners (Broker)
+44 (0) 207 382 1100
Plumtree Capital Limited (Financial Advisor)
+44 (0) 207 183 2493
Yellow Jersey PR
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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.