Moberg Pharma AB (OMX:MOB)(STO:MOB) today announced positive interim results from its ongoing phase ll study of MOB-015. After six months of treatment with MOB-015, 40 per cent of the patients were mycologically cured and no safety concerns were identified. MOB-015 is a novel topical formulation of terbinafine for the treatment of nail fungus (onychomycosis).
The purpose of the study is to confirm the product concept of MOB-015 and provide a basis for out-licensing and further clinical development. 25 patients will be treated for twelve months and followed for a total of fifteen months with respect to the endpoints that the FDA and EMA normally accept for nail fungus. The primary endpoint is the proportion of patients with mycological cure, defined as negative culture and negative KOH microscopy. The study is conducted with leading expertise in the field at Sahlgrenska University Hospital in Gothenburg, Sweden. Patient enrollment in the study was completed in May 2013 and the final results are expected second half of 2014.
"These 6-month interim data are clearly promising and indicate very competitive performance of MOB-015", said Kjell Rensfeldt, VP R&D at Moberg Pharma.
"We are excited to announce the interim data for MOB-015. Oral terbinafine is the gold standard for the treatment of nail fungus. If the final data follow the trajectory of the interim results for this novel topical formulation, MOB-015 has the potential to become a major advance in the treatment of nail fungus", said Peter Wolpert, CEO of Moberg Pharma.
The results from the interim analysis are no guarantee that the final results at study completion will be positive.