Cempra, Inc. (Nasdaq: CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced the initiation of its Phase 2 clinical trial of CEM-102 in patients with prosthetic joint infections (PJIs). CEM-102 is the company's loading dose formulation of fusidic acid, an orally-active anti-staphylococcal agent with a long history of safety and efficacy outside of the U.S.
The Phase 2 study is an open-label clinical trial in which 50 patients with PJIs will be randomized to receive either oral CEM-102 plus rifampin or current standard of care, which is intravenous antibiotic therapy with antibiotics such as vancomycin, nafcillin or cefazolin. The primary outcome measure is demonstration of infection-free status at 12 weeks following initiation of therapy. Long-term monitoring for infection relapse or recurrence will continue for the subsequent two years.
"The availability of an all-oral antibiotic regimen for the treatment of PJI offers the promise of convenient drug administration without the expense and morbidity of maintaining long term venous access," said David Oldach, M.D., FIDSA, senior vice president of clinical research. "We hope that the results of this study will lead to a new option for these patients. We expect to obtain top-line results from this study during the fourth quarter of 2013."
Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra added, "Cempra's mission is to develop differentiated antibiotics for patients with unmet needs. 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."
PJIs occur in about 1% of hip replacements and 2% of knee replacements, with an overall incidence rate of about 10,000 per year in the U.S. at current hip and knee arthroplasty rates. There are few good options to treat these serious staphylococcal, often MRSA, infections, which require long-term antibiotic treatment. Current therapy in the U.S. is with intravenous antibiotics such as vancomycin. An oral drug that can be safely administered for a long period of time could improve care and quality of life for these patients.