CHAPEL HILL, N.C., May 4 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(TM) (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."
TAKSTA, (sodium fusidate) is a novel class of antibiotic with an established history of safety and efficacy outside the United States. TAKSTA is being developed as an NCE in the U.S. for ABSSI. Clinical trials with TAKSTA employ a proprietary front-loading oral regimen designed to optimize efficacy, increase coverage and minimize resistance development. Cempra believes that TAKSTA will be an important addition to anti-MRSA therapies based on the following:
About 60 to 80 percent of the 13 million acute bacterial skin structure infections that occur in the U.S. each year caused by MRSA. There is a growing need for an oral anti-MRSA drug that is safe, effective and is capable of long-term administration.
About Cempra Pharmaceuticals
Founded in 2006, Cempra Pharmaceuticals is a privately-held, clinical-stage pharmaceutical company focused on developing antibacterials to address critical medical needs. Two lead products, both in late-stage clinical trials, address the urgent and increasing need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra is well-funded and is committed to developing commercially and medically differentiated and novel products that reduce development risk and provide a high financial return. The company is also utilizing its proprietary compound library and chemistry technology to develop novel macrolides without antibacterial activity for non-antibiotic uses such as COPD, chronic inflammatory and GI disorders. Additional information about Cempra can be found at www.cempra.com.
-- Sodium fusidate is orally active against gram-positive bacteria, including all S. aureus strains such as HA-MRSA and CA-MRSA -- TAKSTA employs a novel and proprietary PK-PD-based dosing regimen of sodium fusidate that optimizes efficacy and minimizes the risk of resistance development -- Sodium fusidate is the only compound within the fusidane class and therefore is unlikely to select for cross-resistance to other classes of antibiotics -- Sodium fusidate's safety has been well documented even when used for long periods of time (over one year) to treat osteomyelitis and other serious infections including cystic fibrosis-associated staphylococcal infections -- Sodium fusidate has been used safely in children including neonates in countries where it is marketed
SOURCE Cempra Pharmaceuticals