BioCentury
ARTICLE | Clinical News

IV delafloxacin: Phase III started

May 27, 2013 7:00 AM UTC

Rib-X began the double-blind, international Phase III PROCEED trial to compare 300 mg IV delafloxacin twice daily for up to 28 doses vs. 15 mg/kg vancomycin plus 2 g IV aztreonam twice daily for up to 28 doses in about 660 patients. The start triggered a $500,000 milestone payment to Ligand Pharmaceuticals Inc. (NASDAQ:LGND, La Jolla, Calif.). Rib-X has an SPA from FDA for PROCEED, the first of 2 planned Phase III trials, and said EMA also agreed to the study design. The second Phase III trial will evaluate the oral formulation and is slated to begin later this year or early next year. ...