Clinical-stage pharmaceutical company Cempra has commenced a Phase II trial evaluating CEM-102 in patients with prosthetic joint infections (PJIs).
CEM-102 is a novel class of antibiotic and the company’s loading dose formulation of fusidic acid, an orally-active anti-staphylococcal agent, with an established history of safety and efficacy outside the US.
FIDSA clinical research senior vice president Dr David Oldach said the all-oral antibiotic regimen allows the treatment of PJI offering convenient drug administration without the expense and morbidity of maintaining long term venous access.
“We hope that the results of this study will lead to a new option for these patients,” Oldach said.
The open-label trial will randomise 50 patients with either oral CEM-102 plus rifampin or current standard of care, which is intravenous antibiotic therapy with antibiotics including vancomycin, nafcillin or cefazolin.
Infection-free status at 12 weeks following initiation of therapy is the primary outcome of the trial, which is expected to deliver the top-line results during the fourth quarter of 2013.
Long-term monitoring for infection relapse or recurrence will continue for the following two years, according to the company.
Cempra president and chief executive officer Dr 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 III clinical development for community-acquired bacterial pneumonia.”