The previous phase 2 study of MOB-015 showed the delivery of high microgram levels of terbinafine into the nail and through the nail plate into the nail bed
Image: Moberg Pharma and DongKoo collaborate on MOB-015. Photo: Courtesy of Darko Stojanovic from Pixabay.
Swedish pharmaceutical company Moberg has signed a distribution agreement with DongKoo Bio & Pharma for commercialising its MOB-015 in the Republic of Korea.
Under the collaboration, DongKoo holds exclusive rights to market and sell MOB-015 in the Republic of Korea, while Moberg is responsible for production and supply.
Moberg Pharma CEO Anna Ljung said: “This is the fourth commercial agreement for MOB-015, this time with the market leader in dermatology in Korea with excellent coverage of the dermatology clinics. We look forward to work with DongKoo and making MOB-015 available in Korea, contributing to our vision of making MOB-015 the leading nail fungus treatment worldwide.”
Moberg designed MOB-015 as a topical formulation of terbinafine
DongKoo is currently working on registration in the Republic of Korea. Once the registration is completed, the company would market, distribute and sell MOB-015 in the country.
Moberg said that its MOB-015 is a topical formulation of terbinafine, developed based on the previously developed onychomycosis product. Oral terbinafine is the gold standard for treating onychomycosis, however, is associated with safety issues, including drug interactions and liver damage.
The previous phase 2 study of MOB-015 showed the delivery of high microgram levels of terbinafine into the nail and through the nail plate into the nail bed and has resulted in 54% Mycological cure and induced significant clear nail growth in patients.
The significant results of the study include the severity of the nails, where approximately 60% of the nail plate was affected by the infection, and substantially lower plasma levels of terbinafine, reducing the risk of liver toxicities observed with oral terbinafine.
Moberg its MOB-015 is currently being studied under two randomised, multicentre, controlled Phase 3 studies for 52 weeks, on a total of more than 800 patients in North America and Europe.
The primary endpoint for both studies include the proportion of patients being completely cured, and the North American study results are expected in December 2019, followed by European results in the second quarter of 2020.