Moberg Pharma AB, a Swedish pharmaceutical company, has completed patient enrollment in the ongoing phase II clinical trial of MOB-015. MOB-015 is a topical formulation of terbinafine for the treatment of nail fungus (onychomycosis). The aim of this study is to confirm product concept of MOB-015 and provide a basis for a phase III study and out-licensing.

Patients are treated for twelve months and followed for a total of fifteen months with respect to the endpoints that the US FDA and EMA normally accept for nail fungus. The study is conducted with leading expertise in the field at Sahlgrenska University Hospital in Gothenburg, Sweden.

"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," said Peter Wolpert, CEO of Moberg Pharma.

MOB-015 is a new topical treatment for nail fungus with fungicidal, keratolytic (removes dead cells from the skin's outermost layer) and emollient properties. MOB-015 is based on Moberg Pharma's patent pending formulation technology, which in preclinical studies has been shown to transport high concentrations of terbinafine in and through nail tissue. As MOB-015 is applied locally, the side effects associated with oral medications are avoided.

Nail fungus is the most common nail disease and afflicts approximately 10 per cent of the population and is more common among the elderly. The market is expected to exceed US$ 1 billion. Many patients remain untreated and according to specialists in the field, there is a great need for a new topical treatment with a favourable side-effect profile.

Moberg Pharma AB (publ) is a rapidly growing Swedish pharmaceutical company with direct sales through its own sales organisation in the US and sales through distributors in more than 35 countries. The company’s product portfolio includes topical products for the treatment of skin disorders and pain under the brands Kerasal, Jointflex, Kerasal Nail and Kaprolac.