Moberg Pharma have announced that all patients in the European MOB-015 Phase 3 study have completed their last study visit.
The data collection in the study were completed without any negative impact from COVID-19. The timeline remains unchanged with topline results expected by the end of the second quarter.
“We are very grateful that the data collection in the EU study was finalized without any negative impact from the COVID-19 situation in Europe. We expect to announce topline data according to plan, by the end of the second quarter,” says Anna Ljung, CEO of Moberg Pharma.
MOB-015 is a new topical treatment of onychomycosis based on Moberg’s patented proprietary formulation of terbinafine. In the European study, 452 patients were initially randomized and 379 patients completed the study resulting in a drop-out rate of only 16% and avoiding any loss of data due to the current COVID-19 situation in Europe. After the last visit, nail samples are sent to a central lab for mycological testing. Data base lock and statistical analysis are on schedule and will be completed by the CRO partner.
About the Phase 3 study in Europe
The ongoing Phase 3 study is conducted at sites in Germany, UK and Poland and includes a total of 452 patients, 2/3 of whom received MOB-015 and 1/3 who were in the control group and received the most widely used topical treatment. The patients had at least one great toenail that was 20–60 percent affected at start of the trial. Treatment was administered once daily for 48 weeks and patients were followed up for a total of 52 weeks.
Photo of Anna Ljung: Moberg Pharma