Swedish-based pharmaceutical company Moberg Pharma has obtained the US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application, as well as a no-objection letter from Health Canada to start its Phase III trial of MOB-015 for the treatment of onychomycosis.
MOB-015 is an internally developed, topical formulation of terbinafine based on Moberg Pharma’s over the counter (OTC) product Kerasal Nail.
Moberg’s Kerasal Nail is a highly concentrated ointment that heals dry, cracked feet by removing the dry skin and allowing the moisturiser to penetrate into the skin.
Oral terbinafine is considered as the gold standard for treating onychomycosis, despite having safety issues such as drug interactions and liver damage.
The trial has been designed as a randomised, multicentre, vehicle-controlled study, which will evaluate patients for a period of 52 weeks.
The company is planning to begin enrolling patients at the end of this year.
The trial is primarily focused on completely curing the target nail of the patients.
Onychomycosis describes a condition where toenails or fingernails are rendered brittle, discoloured and disfigured due to fungal infection.
The condition may trigger pain and discomfort, ultimately reducing the quality of life.
MOB-015 addresses the safety issues associated to Oral terbinafine, which was previously unsuccessful owing to the inadequate delivery of the active substance through the nail.
Image: Fungal infected nail undergoing terbinafine oral medication. Photo: courtesy of Dandandandandandandan2014.