STOCKHOLM, Dec. 10, 2024 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) announces that MOB-015 (topical terbinafine) did not meet the primary endpoint in the phase 3 study using 8 weeks of daily dosing followed by weekly maintenance dosing. The company's focus going forward will be on the effective daily dosing regimen approved in 13 EU countries.

In line with previous communication on September 13th 2024, the results now confirm that the primary endpoint was not met. The North American Phase 3 study was conducted at 33 study centers in the US and Canada, including a total of 384 patients, 260 patients receiving MOB-015 and 124 patients receiving vehicle. The study differs from previous studies with MOB-015, which is the basis for drug approval in 13 EU countries, by reducing the dosage – 8 weeks daily dosing followed by weekly maintenance treatment for 40 weeks, compared to daily dosing throughout the entire treatment period.

STOCKHOLM, Sept. 13, 2024 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) announces that the company has received information about clinical cure in a subset of patients in the ongoing North American Phase 3 study for MOB-015 against nail fungus. The number of patients who have achieved clinical cure in this blinded subset of patients is lower than the company's expectations, which necessitates that Moberg Pharma inform the market about this fact.

The North American Phase 3 study is ongoing at 33 study centers in the US and Canada, including a total of 384 patients. The study constitutes an essential part of the clinical data required for the registration and commercialization of MOB-015 in the US and differs from previous studies with MOB-015, which is the basis for drug approval in 13 EU countries, by reducing the dosage – 8 weeks daily dosing followed by weekly maintenance treatment for 40 weeks, compared to daily dosing throughout the entire treatment period.