The trial was intended to evaluate the safety, tolerability and pharmacokinetics of 10% solution of luliconazole after maximal use topical application in adults with moderate-to-severe distal subungual onychomycosis of the toenails.
Results showed that all 24 patients enrolled in the study completed the trial at the starting dose, and the 10% luliconazole solution was well tolerated.
Lead study investigator and College Station, Texas dermatologist Terry Jones said these findings together with the results of follow-on photography showing that some patients experienced notable nail clearing despite having moderate-to-severe onychomycosis and a very short course of treatment suggest that the product has the potential to be an effective and safe topical therapy for onychomycosis that merits further clinical research.
To follow the Phase 1/2a study, TOPICA plans to conduct a Phase 2 trial, which will enroll approximately 240 patients with mild-to-moderate distal subungual onychomycosis.
The trial will assess the safety and efficacy of the 10% luliconazole solution in two dosing regimens and evaluate the impact of luliconazole on clear nail growth and fungal eradication.
TOPICA president and CEO Greg Vontz said given luliconazole’s high potency against fungi causing onychomycosis, the formulation’s ability to reach the nail bed and the well tolerated formulation, they believe that the product has the potential to be a highly effective and safe topical therapy for the estimated 35 million adults suffering from onychomycosis in the US.
"Based on the Phase 1/2a results, we plan to advance clinical development of this product with the initiation of a robust Phase 2 trial in the second half of this year. We are currently raising a Series A round to fund the Phase 2 program," Vontz said.
In September 2010, Tinea Pharmaceuticals, formerly Topica Pharmaceuticals, had entered into a sublicense and purchase option agreement with an undisclosed partner to develop luliconazole exclusively for tinea infections of the skin in the Americas and Europe.
Simultaneously, the current TOPICA was spun out of the former Topica.
TOPICA has an exclusive license from Nihon Nohyaku to develop and market luliconazole for onychomycosis in the Americas and Europe.