Moberg Pharma announces submission of applications to start Phase 3 studies for MOB-015
STOCKHOLM, July 5, 2016. Moberg Pharma AB (OMX: MOB) today announced it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MOB-015 in the treatment of onychomycosis. In addition, the Company has submitted Clinical Trial Applications to the regulatory authorities in Germany, Poland and Canada.
The applications concern two randomized, multicenter, controlled Phase 3 studies. In total, approximately 675 subjects will be evaluated over 52 weeks and the primary endpoint will be the proportion of subjects achieving complete cure of their target nail. The company expects to start enrolling patients in the third quarter of this year.
"This is a significant step forward in the further development of MOB-015. We are committed in our pursuit to bring an efficacious and safe topical treatment in the form of MOB-015 to patients suffering from nail fungus”, said Kjell Rensfeldt, VP Research and Development of Moberg Pharma AB.
About MOB-015 and Onychomycosis
Approximately 10% of the general population suffer from onychomycosis and a majority of those afflicted go untreated. The prescription market is growing rapidly after the recent introduction of new topical treatments in North America and Japan. Moberg Pharma expects the U.S. market alone to exceed $2 billion by 2020 and estimates the peak sales potential for MOB-015 to be in the range of $250-$500 million.
MOB-015 is an internally developed topical formulation of terbinafine building on Moberg Pharma’s experience from its leading OTC product Kerasal Nail®. Oral terbinafine is the gold standard for treating onychomycosis, but associated with safety issues including drug interactions and liver damage. For many years, developing a topical terbinafine treatment without the safety issues of oral terbinafine has been highly desirable, but unsuccessful due to insufficient delivery of the active substance through the nail.
For additional information contact:
Peter Wolpert, CEO, Phone: +46 707 35 71 35, E-mail: peter.wolpert@mobergpharma.se
Kjell Rensfeldt, VP R&D, Phone: +46 707 12 4532, E-mail: kjell.rensfeldt@mobergpharma.se
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 8.30 CET on July 5, 2016.
About Moberg Pharma, www.mobergpharma.com
Moberg Pharma AB (publ) is a rapidly growing Swedish pharmaceutical company with OTC sales operations in the U.S. and a distributor network in more than 40 countries. The company’s portfolio includes the OTC brands Kerasal®, Kerasal Nail®, Balmex®, Domeboro®. Kerasal Nail® (Emtrix® or Nalox™ in certain markets) is a leading OTC treatment of nail disorders in the U.S., Canada and several EU markets and is currently being launched in Southeast Asia. The company is growing organically as well as through acquisitions. Internal development programs focuses on innovative drug delivery of proven compounds and include two clinical stage assets, MOB-015 (onychomycosis) and BUPI (pain management in oral mucositis). Moberg Pharma has offices in Stockholm and New Jersey and the company’s shares are listed on the Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm (OMX: MOB).
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