Moberg Pharma AB (publ) said its drug MOB-015 was better than ciclopirox in curing nail fungus in patients enrolled in its late-stage trial of the medicine.
After 52 weeks of treatment, MOB-015 achieved a clinical cure rate of 1.8% during the trial, compared to 1.6% in patients who received ciclopirox — meeting the study's primary goal. Clinical cure refers to an almost or completely clear toenail.
Moreover, the cream was able to achieve a mycological cure, meaning a cure of the fungus itself, in 84% of patients versus 42% for the ciclopirox cohort.
Taking clinical cure and mycological cure rates into account, the treatment success was achieved in 21.9% of patients receiving MOB-015 as opposed to 18.9% for those using ciclopirox, Moberg said in a June 25 press release.
MOB-015 was well tolerated in the trial. Its safety profile was consistent with previous studies, Moberg added.
The trial was conducted in Germany, the U.K. and Poland. It had 452 patients with mild to moderate distal subungual onychomycosis, or DSO, affecting 20% to 60% of the toenail.
Commonly known as fungal nail infection, DSO refers to a condition when a fungal microbe invades the nail bed and causes nails to thicken, discolor, disfigure and split.
In December 2019, the Swedish drugmaker conducted a phase 3 trial in the U.S. and Canada where MOB-015 cured the condition and removed the fungus, meeting the study's main goal.