Cempra commences CEM-102 Phase II PJI trial

17th December 2012 (Last Updated December 17th, 2012 18:30)

Clinical-stage pharmaceutical company Cempra has commenced a Phase II trial evaluating CEM-102 in patients with prosthetic joint infections (PJIs).

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.

"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."

"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."