NXL103 is a novel oral antibiotic made up of two streptogramin antibiotics, linopristin and flopristin, which acts by inhibiting bacterial ribosomes. NXL103 is a bactericidal antibiotic and in vivo studies have shown that this novel antibiotic is not affected by either beta-lactam or macrolide resistance mechanisms.
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In clinical studies to date, NXL103, given to patients on a twice a day basis, has been shown to be generally well tolerated. NXL103 has completed Phase II trials.
NXL103 has a spectrum of activity that indicates it has the potential to be effective in the treatment of skin and skin structure infections, including those caused by MRSA, as well as community acquired pneumonia. Novexel’s future clinical development with NXL103 is expected to focus on its potential to be used in hospitals as an oral agent for the treatment of infections caused by Gram-positive organisms, including resistant pathogens such as MRSA. Currently, physicians have a very limited choice of anti MRSA antibacterials when they wish to switch from intravenous (IV) to oral treatment, a key step prior to a patient being discharged from the hospital. It is estimated that the market for oral agents to treat hospital MRSA is in excess of $500 million in the seven major markets (US, Japan, France, Germany, Spain, Italy and the United Kingdom).
Novexel has recently announced positive results from a Phase II trial with NXL103 in patients with Community Acquired Pneumonia (CAP).
The NXL103 Phase II study was a double-blind, multinational, randomized, comparative study that evaluated this novel oral antibacterial as a treatment for mild to moderate CAP. The study recruited 300 adult patients in 9 countries in both the Northern and Southern hemispheres. Patients were randomised (1:1:1) to three treatment arms: 500mg of NXL103 twice a day, 600mg NXL103 twice a day or 1,000 mg of amoxicillin three times a day for 7 days. The key endpoints of the study were the clinical outcome in the clinically evaluable population at the early follow-up visit (7 to 14 days post-therapy) and safety. In this study, both doses of NXL103 were effective, with clinical response rates similar to those seen in the amoxicillin group. For the primary efficacy analysis, response rates were 91.4% in the 500mg NXL103 group; 94.7% in the 600mg NXL103 group; and 88.5% in the amoxicillin group. NXL103 was generally well tolerated with the most frequent adverse events related to gastrointestinal intolerance. There were no serious drug-related adverse events reported in the study.
The complete results from this Phase II trial will be published in the first half of 2009. (See all our press releases)
The endpoints of the study are clinical outcome at an early follow-up visit and safety. The results of this study with NXL103 are due to be reported in the 1st Quarter of 2009.