SOPHIA ANTIPOLIS, France, June 29 /PRNewswire/ -- NicOx S.A. (Eurolist: COX) today announced the initiation of the third pivotal phase 3 clinical trial for naproxcinod in patients with osteoarthritis of the hip (303 study). The trial is expected to enroll approximately 800 patients at around 100 clinical centers in North America and Europe and is the final phase 3 trial in NicOx’ plan for regulatory filing. The objective of this study is to demonstrate naproxcinod’s efficacy in relieving the signs and symptoms of osteoarthritis of the hip and to provide additional safety data, primarily to confirm naproxcinod’s improved blood pressure profile compared to current treatments. Efficacy results are expected mid-2008.
NicOx aims to develop naproxcinod as the first compound in the COX- Inhibiting Nitric Oxide-Donating (CINOD) class for treating the signs and symptoms of osteoarthritis. NicOx believes that naproxcinod has the potential to become the drug of choice for treating osteoarthritis, based on its unique profile that shows no detrimental effects on blood pressure and a good gastrointestinal tolerability.
Maarten Beekman, Vice President of Clinical Development at NicOx, commented: “The initiation of this pivotal phase 3 trial for naproxcinod marks an important step toward registering and launching our lead compound in the US and Europe. In addition to supplying efficacy data in hip osteoarthritis, the 303 study will provide the final data for a predefined pooled analysis on the blood pressure measurements from the full phase 3 program. We believe that confirming naproxcinod’s improved blood pressure profile over current treatments will be a key differentiating factor in the current anti- inflammatory market.”
The 303 study is the third and final pivotal phase 3 trial in NicOx’ planned clinical development program for naproxcinod. Its initiation follows the successful results obtained in the 301 study, in patients with osteoarthritis of the knee (see press release of October 27, 2006), which demonstrated superior efficacy to placebo, as well as a differentiated and potentially beneficial blood pressure profile compared to naproxen, a widely used non steroidal anti-inflammatory agent (NSAID). NSAIDs are widely recognized to have the tendency to elevate blood pressure and antagonize the beneficial effect of antihypertensive medications to an extent that may increase the rate of serious cardiovascular adverse events, such as heart attack and stroke. NicOx recently initiated the 302 study in patients with osteoarthritis of the knee (see press release of April 3, 2007). Results of both the 302 and 303 studies are expected in mid-2008 and will be included in the New Drug Application (NDA) which is currently planned for the first quarter of 2009.
Trial design and endpoints of the 303 study
The 303 study is a 13-week, double-blind, placebo and naproxen controlled trial in patients with osteoarthritis of the hip. Approximately 800 patients will be enrolled at around 100 clinical centers in the United States, Canada and Europe. Eligible patients will have a diagnosis of primary osteoarthritis
of the hip of at least three-months in duration and will be randomized to three arms: naproxcinod 750 mg bid, placebo bid and naproxen 500 mg bid.
Three co-primary endpoints will compare the efficacy of naproxcinod to placebo, based on the mean change between baseline and week 13 in the following scores: the WOMAC(TM) pain subscale, the WOMAC(TM) function subscale and the 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 the same as those used in the 301 and 302 trials. The 303 study is powered to show statistical significance for the superiority of naproxcinod over placebo at 13 weeks on the three co-primary endpoints. In addition, other variables will be measured in order to assess the general safety and tolerability of naproxcinod.
As in the 301 and 302 studies, patients will undergo standardized blood pressure measurements at each visit to the treatment center (Office Blood Pressure Measurements, OBPM -- see NOTE). NicOx will conduct a predefined statistical analysis on the pooled OBPM data from the three phase 3 studies (301, 302 and 303). The predefined pooled analysis on blood pressure will be conducted, following the completion of the 302 and 303 studies.
NOTE: Office Blood Pressure Measurements (OBPM) are made by a health care professional during a patient’s visit to the treatment center using standard equipment (i.e. a sphygmomanometer). OBPM will be performed in the morning and the time between intake of study-drug and measurement of OBPM should be between 2 and 4 hours.
NicOx (Bloomberg: COX: FP, Reuters: NCOX.PA) 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 pain and inflammation and cardio-metabolic disease. Resources are focused on two lead compounds, naproxcinod (formerly HCT 3012); in phase 3 development for the treatment of signs and symptoms of osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes.
NicOx has strategic partnerships with some of the world’s leading pharmaceutical companies, including Pfizer Inc and Merck & Co., Inc.
NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a public company listed on the Eurolist of Euronext(TM) Paris (segment: Next Economy).
The elements included in this communication may contain forward-looking statements subject to certain risks and uncertainties. Actual results of the company may differ materially from those indicated in the forward-looking statements because of different risks factors described in the company’s document de reference.
NicOx S.A.
CONTACT: Karl Hanks, Manager of Corporate Relations and Market Analysis ofNicOx, +33 (0)4 97 24 53 42, hanks@nicox.com; Investors in the UnitedStates, Lisa Burns, lburns@burnsmc.com, or Laura Siino, +1-212-213-0006,lsiino@burnsmc.com, both of Burns McClellan; or Media in the United States,Jonathan Birt of FD, +1-212-850-5634, jbirt@fd-us.com; or Media in Europe,Valerie Auffray, +44(0)207 282 2979, valerie.auffray@citigatedr.co.uk, orDavid Dible, +44 (0)207 282 2949, david.dible@citigatedr.co.uk, both ofCitigate Dewe Rogerson
Web site: http://www.nicox.com/
