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news.CollaGenex Pharmaceuticals has reported that a phase II study designed to evaluate the safety and determine the therapeutic range of incyclinide for the treatment of acne, has achieved its objectives.
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Incyclinide 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 to 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 10mg 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 to determine the maximum effective dose.
“A 20 mg daily dose of incyclinide delivered a therapeutic benefit similar to that seen with other acne drugs with side effects similar to placebo. I have every reason to believe that a higher dosage will result in even greater efficacy,” said Guy Webster, clinical professor of Dermatology, Jefferson Medical College.
CollaGenex said it plans to initiate phase III clinical trials of incyclinide in acne patients in the first quarter of 2008.