NicOx starts two ABPM studies of anti-inflammatory drug

The 111 study is a 12-week, Phase I, double-blind, parallel group, exploratory trial, where approximately 120 patients will be enrolled at around 30 clinical sites in the US. Patients will have a minimum age of 40 and be diagnosed with controlled essential hypertension and osteoarthritis, with at least one hip or knee involved. After a one week screening period, patients will be randomized to one of two groups, which will receive increasing doses of either naproxcinod or naproxen at three week intervals. A 24-hour blood pressure monitoring will be conducted at baseline and at the end of each three-week dose escalation, using an ABPM device.

The 112 study is a 16-week, Phase I, double-blind, parallel group, exploratory trial, where approximately 300 patients will be recruited at around 60 clinical sites in the US. As in the 111 study, patients will be 40 years, or older, with osteoarthritis in at least one hip or knee and a diagnosis of controlled essential hypertension. Following a one week screening period, patients will be randomized to either one of five groups, which will receive 13 weeks of treatment with: naproxcinod 375mg bid (twice-daily), naproxcinod 750mg bid, naproxen 250mg bid, naproxen 500mg bid or ibuprofen 600mg bid. At the end of the treatment period, all patients will receive placebo for two weeks. A 24-hour blood pressure monitoring will be conducted at baseline and at the end of the 13-week treatment period. The primary objective of the study is to assess the mean change from baseline in the average 24-hour systolic blood pressure, as well as evaluating the general safety and tolerability of naproxcinod.

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). Naproxcinod is NicOx’s 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 III clinical development for the treatment of the signs and symptoms of osteoarthritis. The results of the last two Phase III studies are anticipated in the second half of 2008.