The trial is designed to demonstrate that HCT 3012 is superior to placebo and as effective as a competitor in relieving the signs and symptoms of osteoarthritis, whilst having no detrimental effect on blood pressure.
Drugs for the treatment of arthritic conditions have recently been linked with an increased risk of cardiovascular adverse events, partially due to their propensity to increase blood pressure and interfere with antihypertensive medication. Therefore, a medical need exists for an arthritis drug with a neutral blood pressure-effect, especially among the 40% of osteoarthritis patients which are estimated to have high blood pressure.
The trial will involve approximately 120 clinical study sites and 820 patients in the US. Results are anticipated in the fourth quarter of 2006.
“We believe HCT 3012 has the potential to play a major role in the anti-inflammatory market. Our view is that HCT 3012 could become the reference drug for millions of osteoarthritis patients with hypertension if this phase III program is successful in confirming its lack of interference with blood pressure,” said Michele Garufi, chairman and CEO of NicOx.