NicOx presented phase II clinical results on its lead CINOD compound, HCT 3012 (ex AZD3582), at the European League Against Rheumatism (EULAR) Annual Congress taking place from 9-12 June in Berlin, Germany.
The results demonstrate that after six weeks' treatment with HCT 3012, osteoarthritis patients experienced pain relief equivalent to rofecoxib. At equi-analgesic doses, patients treated with rofecoxib experienced an increase in systolic blood pressure (SBP), an effect particularly evident in hypertensive patients). In contrast HCT 3012 showed no statistical difference in SBP compared to placebo.
Clinical data were generated during the OASIS trial, a randomized, double-blind study conducted to evaluate the efficacy and safety of the first compound in the CINOD class, HCT 3012.
The differences in SBP between the HCT 3012 and rofecoxib treatment groups were statistically significant.
Cardiovascular safety was assessed through SBP measurement at baseline and at multiple time points throughout the six-week treatment period.
HCT 3012 (750 mg bid and 375 mg bid) was shown to be effective in the WOMAC pain subscale and the majority of subjects and investigators rated the overall treatment, disease status and response therapy at six weeks as good or very good. The study was conducted vs. placebo, naproxen 500 mg bid, and a fully active dose of rofecoxib (25 mg qd).
Professor Thomas Schnitzer, Assistant Dean for Clinical Research at Northwestern University (Chicago, USA), commented, "The relevance of potentially harmful effects of NSAIDs and coxibs due to an increase in arterial blood pressure is increasingly acknowledged."
"Even small increases of blood pressure are associated with a significantly increased incidence of cardiovascular events. In that respect, CINODs, through NO release, may potentially counteract the detrimental effects of COX inhibition on blood pressure and may prove to be beneficial in patients with osteoarthritis and concomitant cardiovascular risk factors," he added.
Michele Garufi, chairman and CEO of NicOx, added, "These results support the therapeutic value of the new CINOD class. The European Committee for Human Medicinal Products has recently recommended changes to Cox -2 labeling to strengthen cardiovascular warnings. We believe NicOx's CINOD class could offer patients a potent and safe anti -inflammatory alternative, with a superior CV safety profile."