Determination of Disk Diffusion and MIC Quality Control Ranges for Nafithromycin (WCK 4873), a New Lactone-Ketolide

摘要

Nafithromycin, also known as WCK 4873, is a new orally bioavailable lactone-ketolide currently under development by Wockhardt Bio AG (Switzerland) for the treatment of community-acquired bacterial pneumonia (Fig. 1). Nafithromycin has completed phase 1 single- and multiple-ascending-dose studies in Europe and an intrapulmonary pharmacokinetic study in the United States. Nafithromycin is currently in phase 2 clinical studies for the treatment of community-acquired bacterial pneumonia. Nafithromycin was granted qualified infectious disease product (QIDP) status by the U.S. Food and Drug Administration in 2015. In preliminary studies, nafithromycin demonstrated both in vitro and in vivo activity against macrolide-resistant and telithromycin-intermediate and -resistant pneumococci as well as against other pathogens associated with community-acquired pneumonia (1–3).