The company’s loading dose formulation of fusidic acid, CEM-102, has an established history of safety and efficacy outside the US.
Open-label trial will randomize 50 PJIs patients with either oral CEM-102 along with rifampin or current standard of care antibiotics including vancomycin, nafcillin or cefazolin.
Infection-free status at 12 weeks after the commencement of the treatment is the primary outcome measure of the study while infection relapse or recurrence will be checked for following two years.
Cempra president and chief executive officer Prabhavathi Fernandes said, "Our clinical program of CEM-102 for PJI is an example of this mission along with solithromycin, which is about to enter Phase 3 clinical development for community-acquired bacterial pneumonia."
The company expects to report top-line results from the trial during the fourth quarter of 2013.