Moberg Pharma begins patient enrollment in North American phase 3 study
Moberg Pharma AB (OMX: MOB) today announced that patient enrollment has started in the North American Phase 3 study for MOB-015 (nail fungus treatment).
The randomized, multicenter, vehicle-controlled Phase 3 study will include approximately 350 patients in North America. The patients will be evaluated over 52 weeks and the primary endpoint will be the proportion of subjects achieving complete cure of their target nail. The study design builds on the experience gained from the previous Phase 3 studies. Moberg Pharma will cooperate with the same CRO, lead investigator and successful sites from the previous North American study. The purpose of the new study is to facilitate market approval in the US as well as strengthen the product’s clinical evidence and marketing claims globally.
“The initiation of patient enrollment in the North American Phase 3 study for MOB-015 is a major milestone for Moberg Pharma,” said Anna Ljung, CEO of Moberg Pharma. “Our long-term vision is to become a global leader in onychomycosis and we believe that MOB-015 has the potential to establish a new standard of care. The Phase 3 study have been designed to support registration in North America and runs in parallel with the registration process in Europe where our goal is to receive first market approval and launch in 2023”
For additional information, please contact:
Anna Ljung, CEO, telephone: +46 707 66 60 30, e-mail: email@example.com
About this information
This information is information that Moberg Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 7.00 a.m. CET on May 10th, 2022.
About Moberg Pharma, www.mobergpharma.com
Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company’s main asset, MOB-015, is a novel topical treatment for onychomycosis. Data from phase 3 clinical trials in more than 800 patients for MOB-015 indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in Europe and Japan, among others, and the company's goal is to receive its first market approval and launch MOB-015 in 2023. Moberg Pharma is headquartered in Stockholm and the company’s shares are listed on the Small Cap list of the Nasdaq Stockholm (OMX: MOB).