The study demonstrated that incyclinide was well-tolerated, with most adverse events being mild or moderate.
However, the patients who were administered incyclinide did not demonstrate a greater reduction in inflammatory lesions than the patients on placebo at any time point during the study.
The double-blind, placebo-controlled trial enrolled a total of 197 moderate-to-severe rosacea patients at 19 centers.
Klaus Theobald, chief medical officer of CollaGenex, said: “They are surprised and disappointed that the results of this large, well-controlled Phase II study did not support the findings of an earlier, much smaller pilot study in rosacea patients. On the basis of these results, they will not be pursuing further clinical development of Incyclinide in rosacea patients.”
Colin Stewart, president and CEO of CollaGenex, said: “While clinical disappointments are to be expected in pharmaceutical development, CollaGenex will continue to focus on developing its robust product pipeline. They recently announced outstanding clinical results in their large Phase II study of Col-118 in the treatment of erythema, and we expect to initiate Phase III clinical studies of Col-118 very early in 2008.”