NicOx Initiates Study For Naproxcinod

Armen Hareyan's picture
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NicOx has successfully completed the enrollment of 1020 patients in the 302 pivotal phase 3 study for naproxcinod, in-line with projections. Naproxcinod is the Company's lead investigational drug product and the first compound in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class. The 302 study is designed to assess naproxcinod's efficacy for treating the signs and symptoms of osteoarthritis and provide additional blood pressure data, which is a key factor for differentiating naproxcinod from existing anti-inflammatory treatments. Efficacy results from this study are anticipated in the third quarter of 2008.

The 302 study represents the largest of the three pivotal phase 3 trials for naproxcinod (the 301, 302 and 303 studies). The 301 study is complete and results were recently presented at the 71st annual meeting of the American College of Rheumatology (ACR), which showed that naproxcinod met all three co-primary efficacy endpoints and demonstrated a similar effect on systolic blood pressure to placebo and a reduction compared to naproxen, a commonly used anti-inflammatory agent. The third and final study (303) is a 13-week trial in patients with osteoarthritis of the hip. Patient enrollment in this trial is well underway, following its initiation in June 2007. Current timelines are that the 303 study should complete enrollment in the second quarter of 2008, with results expected by the end of 2008. NicOx now anticipates the filing of a New Drug Application (NDA) for naproxcinod with the US Food and Drug Administration (FDA) in mid-2009.

"The 302 study is the largest and longest duration trial in our program for naproxcinod and our clinical team has proved its effectiveness in successfully recruiting the targeted number of patients in-line with projected timelines," said Pascal Pfister, Chief Scientific Officer of NicOx. "The 302 study will provide 13 and 26-week efficacy results and supportive safety data for the regulatory filing of naproxcinod, in addition to blood pressure data to aid its market differentiation. The completion of patient enrollment in the 303 study is now a top priority and together with the contract research organization for this trial, Covance Inc., we have taken the step of opening additional clinical centers in Europe to accelerate the recruitment in this study."

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302 study design

The 302 study for naproxcinod was initiated in April, 2007 and is being conducted by Premier Research Group plc. This study is a 53-week, randomized, double-blind, efficacy and safety trial in which 1020 patients with osteoarthritis of the knee have been enrolled at 150 clinical sites throughout the United States. Patients have been randomized to one of the following treatment groups: naproxcinod 375 mg bid (52 weeks), naproxcinod 750 mg bid (52 weeks), naproxen 500 mg bid (52 weeks) and placebo bid during the first 13 weeks. After 13 weeks, the placebo treated patients are being randomized to either naproxcinod 375 mg bid or naproxcinod 750 mg bid for the remainder of the trial (39 weeks). Patients have primary osteoarthritis of the knee of at least 3 months duration. The trial has recruited both hypertensive and non-hypertensive patients, although patients with uncontrolled hypertension have been excluded.

The two doses of naproxcinod (750 mg and 375 mg bid) will be compared to placebo on three co-primary efficacy endpoints, based on the mean change between baseline and week-13 in the following scores: the WOMAC pain subscale, the WOMAC function subscale and subject's overall rating of disease status. These are the standard endpoints used to demonstrate the efficacy of drugs for treating the signs and symptoms of osteoarthritis and are the same as those used in the other two pivotal phase 3 studies for naproxcinod. A secondary endpoint of the trial is to compare the efficacy of naproxcinod and naproxen at 26 weeks. The general safety and tolerability of naproxcinod are assessed until week-52 and the trial has a 1-week post-treatment safety period.

Patients' blood pressure is being assessed during each visit to the treatment center, using controlled Office Blood Pressure Measurements (OBPM). The blood pressure effect of naproxcinod will be assessed in the overall population and a sub-group of hypertensive subjects. Various secondary endpoints will compare the different treatments in terms of the mean change from baseline in systolic and diastolic blood pressure, at a range of time points. Additional secondary endpoints will assess the appearance of new hypertension or worsening of pre-existing hypertension.

NicOx is a product-driven biopharmaceutical company dedicated to the development of nitric oxide-donating drugs to meet unmet medical needs. NicOx is targeting the therapeutic areas of inflammation and cardio-metabolic disease. Resources are focused on two lead compounds, naproxcinod (formerly HCT 3012); in

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