Key Therapeutics has entered an exclusive agreement with MerLion Pharmaceuticals GmbH to develop finafloxacin, a novel C-8-cyano 5th generation fluoroquinolone. Systemic and topical formulations of finafloxacin have passed different development stages, including the completion of clinical phase II. In preclinical and clinical studies, involving more than 1,000 subjects overall, finafloxacin has shown none of the toxicity aspects of other, earlier-generation quinolones. Finafloxacin displays an outstanding safety and tolerability profile even with dose levels of up to 1 g/day iv administered for 7 days.
The US Food and Drug Administration (FDA) designated the oral and iv formulations of finafloxacin as a Qualified Infectious Disease Product (QIDP). This includes fast track development status for complicated urinary tract infections (cUTIs) including pyelonephritis, complicated intraabdominal infections (cIAIs) and acute bacterial skin and skin structure infections (ABSSSIs). Finafloxacin has successfully completed a phase II clinical study in cUTI patients and is currently being prepared for cUTI phase III clinical studies. Furthermore, the US FDA has already approved the use of finafloxacin as a topical medication (XtoroTM) for the treatment of acute otitis externa (ear infections, “swimmer’s ear”).
The following table summarizes the areas of interest we are developing product candidates: