NUCRYST'S DERMATITIS CREAM FAILS IN STUDY

Nucryst Pharmaceuticals announced preliminary results from a Phase II clinical trial examining the safety and efficacy of NPI 32101 topical cream in children and adolescents with atopic dermatitis showed no statistical efficacy. This study involved 409 patients at 29 sites in the United States and Canada. Patients 2 to 17 years old with mild to moderate atopic dermatitis were randomized to receive 2 percent NPI 32101 cream, 1 percent NPI 32101 cream or placebo cream twice daily for 12 weeks.

Treatment success was defined as total clearance of disease signs. An intent-to-treat analysis with 387 patients demonstrated no significant difference in disease clearance among the three treatment groups. Analysis of the data demonstrated that 35.8 percent of patients receiving 2 percent NPI 32101 cream, 35.1 percent of patients receiving 1 percent NPI 32101 cream and 34.6 percent of patients receiving placebo cream achieved success in almost clearing or totally clearing their disease after 12 weeks of treatment. The success rates of both 2 percent and 1 percent NPI 32101 creams were statistically identical to that of the placebo. Although the study did not meet its primary efficacy endpoint, the higher-than-expected placebo response rate may have made it difficult to discern efficacy of the drug. A more detailed analysis of the study is under way.

Treatment with NPI 32101 cream was well tolerated. The incidence of all adverse events was low and was not different among the NPI 32101-treated groups and the placebo-treated patients.

"Based on our preclinical results in a variety of in vitro and in vivo models and the consistently favorable safety data generated in all clinical studies, we believe that NPI 32101 has the potential to treat various inflammatory and infectious conditions. Therefore, we plan to continue our efforts to develop NPI 32101 for a variety of disease conditions," said Scott Gillis, president and CEO of Nucryst.