Clinical Trials

* On September 17, 2014, Moberg Pharma announced successful top-line results from a phase II study for MOB-015 in onychomycosis (nail fungus). The primary endpoint, mycological cure after 15 months, was achieved in 54% of the patients.
The purpose of the study was to demonstrate proof-of-concept for MOB-015 in onychomycosis. The open-label clinical study including 25 patients was conducted at Sahlgrenska University Hospital, Sweden with Professor Jan Faergemann as the coordinating investigator. Patients with onychomycosis affecting 25-75% of at least one great toe nail received treatment with MOB-015 during 12 months and were followed for a total of 15 months. The study included patients with more severe onychomycosis than recently published studies of topical treatment alternatives. Of the 24 patients who completed the study, 13 (54%) met the primary endpoint, mycological cure, defined as both negative microscopy and fungal culture after 15 months from start of treatment. The secondary endpoint, mycological cure and excellent clinical improvement or cure was observed in 7 of 24 patients (29%). Biopsies confirmed high levels of terbinafine in the nail plate and nail bed (median values 1610 and 45 ug/g, respectively). MOB015 was generally well tolerated. The company is now proceeding with partner discussions for further development and commercialization of MOB-015.

* On December 13, 2013, Moberg Pharma has 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. 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.

* On November 7, 2012, Moberg Derma has announced that it has received the final results from a phase II study of MOB-015 in patients with onychomycosis. The clinical efficacy was unsatisfactory, and the company has therefore decided to initiate a new study with an improved formulation.

Based on the final results of the completed study, the company reiterates the assessment announced already in connection with a previous analysis of interim data; that the studied formulation of MOB-015 is not efficacious enough to justify further development. The study has provided valuable information that has been used in the development of a new formulation of MOB-015 with improved penetration capability. The company has decided to initiate a new phase II study with this new formulation. Approvals from the Swedish Medical Products Agency and the Ethics Committee have been obtained. The first of a total of 35 patients will be included in the trial already in December this year.