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Novexel Reports Positive Phase II Trial Results With NXL103 in Adult Patients With Community Acquired Pneumonia

Thursday, October 23, 2008 General News J E 4
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PARIS, October 23 Novexel, a speciality pharmaceuticalcompany focused on the discovery and development of novel antibioticsdesigned to overcome the significant global problem of microbial resistance,announces positive results from its Phase II clinical trial evaluating NXL103in the treatment of community acquired pneumonia (CAP). NXL103 is a noveloral streptogramin antibiotic that has potent in vitro activity againstcertain Gram positive bacteria including methicillin resistant Staphylococcusaureus (MRSA) as well as the important respiratory pathogens includingpenicillin, macrolide and quinolone resistant strains.

The NXL103 Phase II study was a double-blind, multinational, randomized,comparative study that evaluated this novel oral antibacterial as a treatmentfor mild to moderate CAP. The study recruited 300 adult patients in 9countries in both the Northern and Southern hemispheres. Patients wererandomised (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 7days. The key endpoints of the study were the clinical outcome in theclinically evaluable population at the early follow-up visit (7 to 14 dayspost-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 500mgNXL103 group; 94.7% in the 600mg NXL103 group; and 88.5% in the amoxicillingroup. NXL103 was generally well tolerated with the most frequent adverseevents related to gastrointestinal intolerance. There were no seriousdrug-related adverse events reported in the study.

The complete results from this Phase II trial will be published in thefirst half of 2009.

NXL103 has a spectrum of activity that indicates it has the potential tobe 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 itspotential to be used in hospitals as an oral agent for the treatment ofinfections caused by Gram positive organisms, including resistant pathogenssuch as MRSA. Currently, physicians have a very limited choice of anti-MRSAantibacterials when they wish to switch from intravenous (IV) to oraltreatment, a key step prior to a patient being discharged from the hospital.

In the second quarter of 2008 sanofi-aventis elected not to exercise itsoption to develop and commercialise NXL103. Consequently, worldwide rights tothe NXL103 programme are retained by Novexel.

Iain Buchanan, Novexel's CEO, commenting on the announcement said, "Weare very pleased that the results from our first Phase II clinical trial withNXL103 are positive. The data from this trial confirm the efficacy of NXL103in patients with mild to moderate CAP. Furthermore, the pre-clinical andclinical work that we have carried out to-date with NXL103 provides acompelling platform for Phase III development. We believe that with itspotent activity against MRSA, NXL103 may offer physicians an importanttherapeutic option when they switch patients from IV to oral treatment priorto discharge from the hospital."

About Novexel

Novexel is a speciality pharmaceutical company focused on the discoveryand development of novel anti-bacterials designed to overcome the significantglobal problem of bacterial resistance. The ever increasing resistance tomarketed antibiotics has led to a clear need for novel drugs that are activeagainst multi-drug resistant bacteria. Novexel's products are targeting theglobal hospital antibiotic market, which was worth an estimated $15bn in 2007according to information derived from the IMS Midas(R) database.

Novexel currently has two novel antibacterials in Phase II clinicaldevelopment. These are the injectable beta-lactamase inhibitor, NXL104, whichis being developed in combination with the cephalosporin antibioticceftazidime for serious Gram negative infections, and the oral streptograminantibiotic, NXL103, for the treatment of Gram positive infections, with afocus on treatment in the hospital setting and intravenous (IV) to oralswitch. Novexel has three further programmes in preclinical development,NXL105, a novel anti-Pseudomonal antibiotic, NXL201, a novel echinocandinantifungal agent, and NXL104 in combination with ceftaroline. This latterproduct is being developed by our partner, Forest Laboratories, solely forNorth American markets.

Novexel was created in December 2004 as an independent spin-out of thesanofi-aventis (Euronext Paris: SAN, NYSE: SNY) anti-infectives unit. Novexelhas a team of 50 employees with significant experience in anti-infectiveresearch and development, who are located in Paris, France and Philadelphia,USA.For further information please contact: Novexel Gordon Waldron, CFO Tel: +33-1-5714-0777 gordon.waldron@novexel.com Citigate Dewe Rogerson Amber Bielecka/David Dible/Nina Enegren Tel.: +44-(0)207-638-95-71 amber.bielecka@citigatedr.co.uk

SOURCE Novexel
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