The US Food and Drug Administration approved the company’s investigational new drug application, while Health Canada has issued a no objection letter.
Moberg Pharma will commence patient enrollment in the US and Canada pending approval from the Institutional Review Board (IRB/independent ethics committee).
The company will assess patients over 52 weeks and the primary endpoint will be the proportion of patients achieving complete cure of their target nail.
Patient enrollment is expected to commence in the third quarter of this year.
MOB-015 is an internally developed topical formulation of terbinafine building on Moberg Pharma’s experience from its OTC product Kerasal Nail.
In a phase 2 study, MOB-015 demonstrated delivery of high microgram levels of terbinafine into the nail, as well as through the nail plate into the nail bed.
Mycological cure of 54% and significant clear nail growth was also seen in patients who completed the phase 2 study.
The company said plasma levels of terbinafine with MOB-015 were lower, compared to oral administration, lowering the risk of liver toxicities observed with oral terbinafine.