TOPICA's IND for onychomycosis antifungal agent accepted by FDA

TOPICA Pharmaceuticals, a privately-held biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for the use of luliconazole, its lead product candidate, in patients with onychomycosis (nail and nail bed fungal infections). The company plans to initiate a Phase 1/2 trial in the first quarter. Luliconazole is one of the most potent and broad-spectrum topical antifungal agents in development and will be advancing to Phase 3 clinical development in the U.S. for tinea pedis (athlete's foot).  

"The FDA's acceptance of our IND for luliconazole is a significant step forward in realizing our goal of bringing this product to market in the United States as the first highly effective and safe topical therapy for onychomycosis," said Greg Vontz, president and CEO of TOPICA Pharmaceuticals.  "We believe the comprehensive development program completed for luliconazole in Japan, where the drug is approved for tinea infections, has greatly aided its advancement through the IND process. The FDA's guidance throughout the IND process has allowed us to effectively advance our clinical development plans to prepare for the initiation of our Phase 1/2 trial this quarter, which will support our objective of initiating a robust Phase 2/3 program in onychomycosis later this year."

The Phase 1/2 trial will be conducted in patients with moderate to severe distal subungual onychomycosis and will evaluate 28 days of treatment with luliconazole 10% solution given once daily.  The safety, tolerability and pharmacokinetic profile of the luliconazole will be assessed.  Patients will also be followed post treatment for 30, 60, and 90 days assessing the concentration of luliconazole in the infected nails, mycologic effectiveness and amount of new clear nail growth.  Additional information about the trial can be found at www.clinicaltrials.gov.

"Luliconazole's antifungal profile suggests it has the potential to be successful in treating onychomycosis. If approved, it will provide a new treatment option for this prevalent and difficult-to-treat condition," said David Cohen, M.D., M.P.H., a leading dermatologist and Vice Chairman for Clinical Affairs at the New York University School of Medicine Department of Dermatology.  "I look forward to participating with TOPICA in the development of this promising compound for onychomycosis."