Moberg Pharma announces that MOB-015 (topical terbinafine) did not meet the primary endpoint in its North American phase 3 study using 8 weeks of daily dosing followed by weekly maintenance dosing. The study, conducted at 33 centers in the US and Canada with 384 patients, showed that the shorter treatment regimen was insufficient compared to the daily dosing throughout treatment period approved in 13 EU countries.
Following these results and strategic considerations, Bayer Consumer Health has decided to stop the upcoming launch of MOB-015, leading to a mutual termination of the license agreement. Moberg Pharma will regain full rights for MOB-015 in EU while retaining previously paid milestone revenues. The company will shift focus to the European market, where MOB-015 (branded as Terclara®) is already successful in Sweden, growing the market by 44% and achieving 76% mycological cure with daily dosing.