IV and oral finafloxacin regulatory update

MerLion said FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for IV and oral finafloxacin to treat complicated intra-abdominal infections (cIAI), acute bacterial skin and skin structure infections (ABSSSI) and complicated urinary tract infections (cUTI), including pyelonephritis. A Phase II trial is evaluating a short-course, high-dose, IV finafloxacin regimen with an oral step-down option to treat cUTI. The trial is expected to complete early next year. Both formulations of the pH activated fluoroquinolone antibiotic completed Phase IIa trials to treat uncomplicated UTI and Helicobacter pylori infection. ...