NicOx initiates two large ABPM studies for naproxcinod in hypertensive patients with osteoarthritis
NicOx S.A. announced the initiation of two large clinical pharmacology studies in the United States, which will assess the blood pressure profile of naproxcinod in comparison to ibuprofen and naproxen, using the Ambulatory Blood Pressure Monitoring (ABPM) technique. These separate studies, 12 and 16 weeks in duration, will together recruit a total of around 420 osteoarthritis patients with controlled hypertension and results are projected in Q4 2008. Naproxcinod is NicOx' lead investigational drug and the first compound in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents, which is currently in phase 3 clinical development for the treatment of the signs and symptoms of osteoarthritis, with results of the last two phase 3 studies anticipated in the second half of 2008.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen and naproxen, are commonly used by osteoarthritis patients to control their chronic pain, inflammation and stiffness and significantly improve quality of life for millions of people. However, these important products have the tendency to raise blood pressure to an extent that may increase the rate of serious cardiovascular adverse events.
Pascal Pfister MD, Chief Scientific Officer and Head of Research and Development at NicOx, said: "Our development program for naproxcinod aims to address the safety concerns surrounding anti-inflammatory agents and blood pressure, which represents a serious medical issue. Previous studies using the ABPM technique and Office Blood Pressure Measurements have suggested that naproxcinod may have an improved blood pressure profile compared to existing anti-inflammatory drugs, which would greatly facilitate its future adoption by physicians and patients. These two new studies will provide important data in a relevant population of chronically treated osteoarthritis patients and should add additional weight to the consistent data we are accumulating on naproxcinod's blood pressure profile."
The objectives of these new ABPM studies are to provide important additional data on the 24-hour blood pressure profile of naproxcinod in chronically treated osteoarthritis patients, in comparison to commonly used Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These data should complement the promising results of a 2-week ABPM study for naproxcinod in healthy volunteers with hypertension (the 104 study), which were presented at the American Heart Association (AHA) in November 2007. They will also complement the Office Blood Pressure Measurements (OBPMs) being collected in each of the pivotal phase 3 osteoarthritis studies (including the completed 301 study and the ongoing 302 and 303 studies).
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