June 1, 2011
Potential for Developing Fusidic Acid (TAKSTA(TM), CEM-102) in the U.S. is Profiled in Clinical Infectious Disease
CHAPEL HILL, N.C., June 1, 2011 /PRNewswire/ -- Cempra Pharmaceuticals, a developer of differentiated antibiotics, announced the publication of a Clinical Infectious Disease supplement (Vol. 52, Supplement 7) that profiles fusidic acid and specifically TAKSTA(TM) (CEM-102), administered using a proprietary loading dose regimen, for use in treating acute bacterial skin and skin structure infections (ABSSSI) in the U.S.
Articles contributed by experts in infectious disease discuss a range of topics that describe the compound's potent in vitro activity against U.S. strains of Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA) and streptococci, the two most common pathogens associated with ABSSSI. The rationale underlying Cempra's proprietary loading dose regimen is discussed along with its excellent tolerability and pharmacokinetic profile in healthy volunteers in Phase 1 trials. The positive results of a Phase 2 clinical trial, comparing TAKSTA to oral linezolid, in patients with ABSSSI, suggest comparable tolerability and efficacy. A case report of a patient with refractory MRSA-infected chronic osteomyelitis facing amputation treated with oral daily doses of fusidic acid for nine months reinforced the compound's excellent tolerability. The patient's infection also improved rapidly during treatment with the drug.
"Fusidic acid has been a valuable antibiotic for treating ABSSSI in many countries outside the U.S. for several decades," said Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra and a contributing author to the supplement. "MRSA infections continue to be a serious problem in the hospital as well as in the community so the need for new agents, particularly orally-administered drugs, is critical. Fusidic acid is a promising candidate to treat ABSSSI infections in the U.S. because of its potency against U.S. MRSA strains and its excellent safety profile. Our proprietary dosing regimen, based on the compound's pharmacokinetic and pharmacodynamic profile, should maximize efficacy while minimizing resistance development. This supplement provides U.S. clinicians and scientists an opportunity to learn more about fusidic acid and its clinical development in the U.S."
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 ABSSSI. Clinical trials with TAKSTA employ a proprietary front-loading oral regimen designed to increase potency, increase coverage and minimize resistance development. Cempra believes that TAKSTA will be an important addition to anti-MRSA therapies based on the following:
- 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
- Sodium fusidate has been used safely in children including neonates in countries where it is marketed
About 60 to 80 percent of the 13 million acute skin structure infections that occur in the U.S. each year are infected with MRSA. There is a growing need for an oral anti-MRSA drug that is effective and is safe for 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.
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