Topica Pharmaceuticals has initiated patient enrollment in a Phase II clinical trial evaluating luliconazole for the treatment of tinea pedis.
The Phase II, multi-center, randomized, double-blind trial is evaluating the safety and optimal duration of 1% luliconazole cream administered once daily for 14 or 28 days in patients with tinea pedis.
The primary efficacy endpoint is to achieve complete clearance of the infection at two weeks post treatment. It is reported that currently in the US, available prescription medications generally require treatment once or twice a day for up to four weeks to achieve this result. The company expects to enroll approximately 120 patients in the trial, which is being conducted at five clinical trial sites in the US.
Luliconazole, the company’s lead product candidate, is reported to be one of the most potent and broad spectrum molecules in the imidiazole class of antifungal agents, giving it the potential to provide physicians and patients with a needed topical solution to a variety of skin and nail fungal infections.
Greg Vontz, president and CEO of Topica, said: The initiation of this trial represents a significant milestone for Topica as we begin our US clinical development program of this promising drug candidate, which already has been proven in millions of patients in Japan. We expect to complete this trial by the end of 2009, potentially enabling us to initiate our pivotal Phase III clinical trial in 2010.