The study will confirm the product concept of the topical formulation of terbinafine MOB-015 in addition to providing a basis for a Phase III study and out-licensing.
Moberg Pharma CEO Peter Wolpert said, "MOB-015 has the potential to become a valuable addition to our product portfolio and we look forward to the outcome of the study during next year."
Subjects are treated for twelve months and observed for fifteen months with respect to the FDA and EMA accepted endpoints for nail fungus.
The company’s patent pending formulation technology, shown to transport high concentrations of terbinafine in and through nail tissue, was leveraged in the development of MOB-015.
Oral medication associated side effects are avoided due to the local application of the product.