MerLion Pharmaceuticals, has completed the planned recruitment into its Phase II trial in patients hospitalised with Complicated Urinary Tract Infection, including pyelonephritis (“cUTI”) in Germany and Poland.
The trial is a multi-dose, double-blind, double-dummy, active-control, randomised 3-arm study to evaluate the safety, tolerability, efficacy and pharmacokinetics of finafloxacin.
MerLion expects to report top-line results from the study by the end of Q3 2014.
Mr. David Dally, chief executive officer, of MerLion, commented, “The study is designed to test the safety and efficacy of different finafloxacin dose regimens with an “intravenous (“iv”) to oral step-down” option for the treatment of cUTI and pyelonephritis. We believe that finafloxacin will offer the real possibility of reduced treatment durations and concomitant shorter stays in hospital, thus improving patient convenience and significantly lowering the costs of hospitalisation and treatment. Reduced hospitalisation periods should also reduce the risk of nosocomial infections and of generating drug-resistant strains through extended therapy.”
Florian Wagenlehner, M.D., Ph.D., Clinic for Urology, Pediatric Urology and Andrology, Justus-Liebig University Giessen, Germany, lead investigator of the study stated; “We very much look forward to the results of this exciting study and anticipate that they will allow us to determine the optimum dosing regimen for Finafloxacin and to confirm the drug’s potential for use as a short course high dose treatment of patients with cUTI and pyelonephritis."
Finafloxacin is a next generation, highly differentiated, fast acting fluoroquinolone antibiotic with an excellent safety profile. The antibacterial activity of finafloxacin increases significantly under infection relevant conditions (i.e. at pH values below neutral). The compound exhibits a very broad spectrum of activity that covers Gram positive, Gram negative, anaerobic and atypical pathogens.
In August 2013 the FDA designated finafloxacin as a Qualified Infectious Disease Product (“QIDP”) and also granted Fast Track approval status for the drug’s use in treatment of cUTI (including pyelonephritis), complicated intra-abdominal infections and acute bacterial skin and skin structure infections.
Whilst MerLion retains the global rights to the use of iv. and oral formulations of finafloxacin for treating serious hospital infections, the compound has been partnered in North America with a major company for the treatment of optic (ear) infections, where development of a topical formulation has been successfully completed.