COLLAGENEX ANNOUNCES RESULTS FROM ACNE TREATMENT STUDY

CollaGenex Pharmaceuticals has announced the results of a Phase II dose-finding study designed to evaluate the safety and determine the therapeutic range of incyclinide for the treatment of acne. The study achieved its objectives and demonstrated an excellent side effect profile similar to placebo. A clear dose-response relationship was also observed.

While the study was not powered for statistical significance, incyclinide showed a statistically significant clinical benefit compared with placebo at certain dosages and time points during the study. The study determined the minimum effective incyclinide dose for the treatment of acne, which was 10 mg per day, and greater efficacy was observed at 20 mg per day. CollaGenex will continue the dose-optimization trial and initiate an additional cohort with the objective of determining the maximum effective dose.

The double-blind, placebo-controlled trial enrolled 302 acne patients at 27 centers. The patients were divided among four arms of the study and administered either a placebo capsule or a 5-, 10- or 20-mg incyclinide capsule. Patients were enrolled in three sequential cohorts, each consisting of an active treatment group and a smaller placebo group. The total number of placebo patients across the three cohorts was approximately the same as each of the active treatment groups.

The primary endpoint of the study was the reduction in inflammatory lesion count at 12 weeks. Patients were evaluated at baseline and weeks 3, 6, 9, 12 and 16. The average number of inflammatory lesions at baseline was approximately 24 and well balanced across the four treatment arms.

Incyclinide was well tolerated with most adverse events being mild or moderate. The adverse events were equally distributed across all treatment groups, including placebo.