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news.Topica Pharmaceuticals has announced that the FDA has accepted its 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.
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Luliconazole is a potent and broad-spectrum topical antifungal agent in development and will be advancing to phase 3 clinical development in the US for tinea pedis (athlete’s foot).
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 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.
Greg Vontz, president and CEO of Topica, said: “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.
“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.”