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Omiganan 2.5% gel shows promise in Phase II rosacea trial

Thursday, November 15 2007 | Comments

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What's This? Cutanea Life Sciences selected the once-daily dose of omiganan pentahydrochloride 2.5% topical gel, an antimicrobial peptide, for further development as a treatment for papulopustular rosacea, based on the results of a Phase II trial.

The exploratory Phase II trial included 240 patients with moderate to severe papulopustular rosacea who were randomized into 1 of 5 treatment groups for the 9-week treatment period: omiganan 1% once daily, omiganan 2.5% once daily, omiganan 2.5% twice daily, vehicle once daily, or vehicle twice daily.

The trial's primary efficacy endpoint was mean percent reduction in the number of inflammatory lesions from baseline to week 9.

Patients in the once-daily omiganan 2.5% group experienced a mean 31% reduction in the number of inflammatory facial lesions compared with a 14% reduction seen in patients who received once-daily vehicle, but the between-group difference was not statistically significant. For patients who had at least 18 lesions at baseline, the mean reduction among the once-daily omiganan 2.5% group was 40%; for these same patients in the once-daily vehicle group, there was an 11% increase in lesions.

At week 9, in both the intent-to-treat and the per-protocol populations, once-daily treatment with omiganan 2.5% was found to be statistically significantly better than vehicle once daily in the absolute change of inflammatory lesions.

"While in this exploratory study this endpoint was identified as a secondary endpoint, [the] FDA currently requires the absolute change (rather than percent change) in the number of inflammatory lesions as one of the coprimary endpoints, along with treatment success, for demonstrating efficacy in a Phase III trial in rosacea," Cutanea said.

The firm noted that the trial found omiganan 2.5% to be better than omiganan 1% at lesion reduction and treatment success, but that twice-daily application was not substantially better than once-daily application.

Based on these findings, the firm will move forward with Phase III development of omiganan 2.5% once daily.

This information concerns a use that has not been approved by the Food and Drug Administration.

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