CombinatoRx Inc, of Boston, Massachusetts, announced the discontinuance of its phase IIa drug candidate CRx-140 (low dose of cyclosporine and loratadine) for psoriasis due to failure to achieve statistical significance in the primary and secondary efficacy endpoints of reduction in Physician Global Assessment (PGA) and Psoriasis Area Severity Index (PASI) versus active control in patients with psoriasis.
Principal investigator Alice Gottlieb, MD, will present preliminary results on March 5, 2006, at the American Academy of Dermatology annual meeting in San Francisco, California. This trial in subjects with severe psoriasis compared 12 weeks of CRx-140 to low-dose cyclosporine in a 1:1 ratio with the primary endpoints of PGA and safety and a secondary endpoint of PASI. The study enrolled 103 patients at study centers in the US and Canada. CRx-140 was one of a portfolio of seven product candidates that CombinatoRx is currently testing in phase II clinical trials.
Earlier in 2006, CombinatoRX announced positive preliminary results in its multicenter, randomized, blinded, placebo-controlled phase IIa clinical trial of CRx-102 (low dose of prednisolone and dipyridamole) in patients with osteoarthritis of the hand. This trial enrolled 83 subjects at four Norwegian study centers and evaluated the effect of a 6- week treatment of CRx-102 compared to placebo in a 1:1 ratio with a primary endpoint of pain relief. The study met its primary endpoint of improvement in the AUSCAN visual analogue pain scale. Analysis of the primary endpoint shows mean change from baseline in the CRx-102 group was -102.4 mm compared to -30.9 mm in the placebo group (P = .006). CRx-102 is currently under study in two additional phase II clinical trials in patients with rheumatoid arthritis and in a systemic inflammatory disease model, chronic adult periodontitis.
— A. Techman