Cempra Pharmaceuticals today announced positive results from its Phase 2 clinical trial evaluating the efficacy and tolerability of the novel front loading dosing regimen of TAKSTA™ (CEM-102, sodium fusidate), the company's oral, anti-methicillin-resistant Staphylococcus aureus (MRSA) antibiotic. The study demonstrated efficacy comparable to linezolid in patients with acute bacterial skin and skin structure infections (ABSSSI) indicating that TAKSTA will have a high probability of demonstrating non-inferiority vs. linezolid in pivotal Phase 3 trials. The TAKSTA loading dose regimen was well tolerated.
Sodium fusidate has an established track record of efficacy and safety outside the U.S. for treating gram positive infections, including MRSA. The novel proprietary oral dosing regimen under development in the U.S. is based on extensive PK-PD modeling--employing defined drug loads chosen to optimize the efficacy and spectrum while preventing selection of resistant organisms--that was validated in preclinical and Phase 1 single- and multi-dose clinical trials. In the U.S., TAKSTA is in clinical development for the treatment of ABSSSI, caused by gram-positive bacteria, especially drug-resistant strains such as MRSA.
Efficacy and tolerability of the front-loading dose regimen of TAKSTA were compared to oral linezolid in patients with wound infections and cellulitis. In this double-blind randomized study, 198 patients were assigned to one of the treatment arms. Drug administration was for 10-14 days. The loading dose regimen was well tolerated and showed efficacy comparable to linezolid in this trial.
"We have applied new advanced methods of PK/PD system analysis to allow CEM-102's development as monotherapy for serious staphylococcal and streptococcal skin infections," said Paul G. Ambrose, Pharm. D., F.I.D.S.A., director, Institute for Clinical Pharmacodynamics, Ordway Research Institute. "We are very encouraged that our laboratory work showing that upon proper exposure to the antibiotic, efficacy can be optimized while at the same time decreasing the probability resistance will develop on therapy. The results from the Phase 2 study suggest that we may have attained these goals."
Michael L. Corrado, M.D. , F.I.D.S.A., a director at Cempra and chief scientific officer and chief regulatory officer at INC Research, said " From these data it would appear that CEM 102 offers an additional potential treatment for gram positive skin and soft tissue infections. There are few drugs which can be given orally and which could treat both hospital and community acquired S. aureus infections. If further trials continue to support these observations they will support the basis of intelligent designing of clinical trials based on pharmacodynamic methods. This is how infectious disease trials should be conducted."
Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra added, "Resistance to current anti-bacterial therapies has increased in the community and patient enrollment in the trial, which was completed ahead of expectations, is evidence for the need of new oral agents to treat these difficult infections that have the potential to result in death. We believe that orally-administered TAKSTA will provide physicians the opportunity to keep patients with serious infections out of the hospital, thereby reducing costs on the healthcare system and improving patient convenience and outcomes. We are looking forward to presenting the complete data set at an upcoming medical conference this year and to initiating the Phase 3 trial in the near future."
SOURCE Cempra Pharmaceuticals