MOBERG DERMA IS GRANTED PERMIT TO INITIATE PHASE II-TRIAL FOR MOB-015
The Swedish Medical Products Agency has granted Moberg Derma permit to initiate a clinical phase II trial for MOB-015. MOB-015 is Moberg Dermas next generation topical treatment for nail fungus, with fungicidal, keratolytic and emollient properties.
Nail fungus (onychomycosis) chiefly manifests itself in thickening and discoloration of the nails. The disease is common, affecting about 100 million patients in Europe and North America, the great majority of those infected being untreated.
”Our chances for succeeding with the therapy are increasing as the active ingredient in MOB-015 is already in use for oral treatment of nail fungus. MOB-015 has the potential to become the first topical treatment with better efficacy and without the safety issues associated with oral therapy for nail fungus”, say Peter Wolpert, CEO and founder of Moberg Derma.
“We are excited to initiate the phase II trial. The new treatment has the potential to help millions of untreated patients”, he continues.
The phase II trial, which includes 250 patients, is designed to provide clinical proof-of-concept for MOB-015 and to provide guidance for the phase III program. Patients will be followed-up during 12 months and the endpoints normally accepted by FDA, EMA and other relevant authorities for nail fungus will be used.
About MOB-015 and nail fungus
MOB-015 is a new topical treatment for nail fungus (onychomycosis) with fungicidal, keratolytic and emollient properties. Moberg Dermas patent-pending formulation technology facilitates high concentrations of a fungicidal substance to be transported in and through nail tissue. In pre-clinical studies on human nails, more than tenfold concentrations of the antifungal substance have been detected, compared to the concentrations measured in the nail with successful oral treatment. As MOB-015 is applied locally, the side effects associated with oral treatment are avoided.
Nail fungus is the most common nail disease and afflicts approximately 10% of the general population and increasing with age. The estimated global market potential exceeds USD 1 billion. The untapped potential is significant since many patients remain untreated. It is generally recognized that there is a need for new efficacious and safe topical treatments.
For further information, please contact:
Peter Wolpert, President and CEO of Moberg Derma
Telephone: +46 8 522 307 00, Mobile: +46 735 71 35
About Moberg Derma
Moberg Derma AB, based in Stockholm, develops patented topical pharmaceuticals for the treatment of common disorders through the use of innovative drug delivery. The company’s products are based on proven compounds, which reduce time to market, development costs and risk. The portfolio covers projects in the preclinical phase to approved and launched products. The Company began operations at the Karolinska Institute in Stockholm in 2006. Moberg Derma is owned by institutional and private investors, Board and management. For further information, please visit: www.mobergderma.se