PARIS, Nov. 6, 2009 (PR Newswire Europe) --
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- Trial Will Compare NXL103 With Leading Oral Agent Linezolid for
the Treatment of Multi-Resistant Staphylococcus Aureus (MRSA) Infections
Novexel, a speciality pharmaceutical company focused on the
discovery and development of novel antibiotics designed to overcome the
significant global problem of microbial resistance, announces today that its
most advanced oral antibacterial NXL103 (flopristin/linopristin), has started
a Phase II clinical trial in adults with acute bacterial skin and skin
structure infections (ABSSSI). The trial is designed to assess the safety and
efficacy of NXL103 in comparison to oral linezolid (Zyvox, Pfizer NYSE:PFE).
The comparative Phase II trial with NXL103 is a prospective, multicenter,
investigator-blinded, two-arm, parallel group study carried out in adults,
either in hospital or as outpatients, with ABSSSI. Patients will be
randomized to receive either NXL103 (500 mg twice a day) or linezolid (600mg
twice a day), with 120 patients receiving NXL103 and 60 receiving linezolid.
The treatment period in both study arms will be between 10 and 14 days.
The primary endpoint of the study is the clinical outcome in the
clinically evaluable population at the Test of Cure (TOC) visit (7 days
post-therapy). Secondary end points of the study include microbiological
response at the TOC visit as well as evaluating the tolerability and safety
of NXL103.
This comparative Phase II study is expected to recruit a total of 180
patients from approximately 20 sites in the USA and Central America. The
study is expected to be completed in 2010 and is a critical part of Novexel's
clinical development plan for NXL103 which is focused on its potential to be
used in hospitals and out-patients as an oral agent for the treatment of
infections caused by Gram-positive organisms, including MRSA. Currently,
physicians have a 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 able to be discharged from the hospital.
NXL103, as a member of the Streptogramin class of antibiotics, has a
unique mode of action, with its two components acting synergistically to
inhibit the bacterial ribosome.
