Moberg Pharma Begins Patient Enrollment in Two Phase 3 Studies of MOB-015

Moberg Pharma (STO:MOB) Moberg Pharma AB (OMX: MOB) today announced that patient enrollment has started in U.S., Canada and Germany in the Phase 3 program investigating MOB-015 for the treatment of onychomycosis.
MOB-015 is being evaluated over 52 weeks in two randomized, multicenter,
controlled Phase 3 studies. The primary endpoint in both studies is the
proportion of patients achieving complete cure of their target nail. In
total, approximately 700 patients are expected to be enrolled in the two
studies.
In addition to the previously announced approvals of a North American
Phase 3 study from the FDA and Health Canada, a European Phase 3 study
was recently approved by the regulatory authority in Germany. Moberg
Pharma is also expecting approval from the Polish authorities.
“The start of the patient enrollment in the Phase 3 program for MOB-015
is a major milestone for Moberg Pharma,” said Peter Wolpert, 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 studies have been designed to
support registration in North America, Europe and other major markets.”
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 September 28, 2016.
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.
In a previous phase 2 study, MOB-015 demonstrated delivery of high
microgram levels of terbinafine into the nail and through the nail plate
into the nail bed. Mycological cure of 54% and significant clear nail
growth was observed in patients who completed the phase 2 study. The
results are remarkable, particularly when taking into account the
severity of the nails included in the study – on average approximately
60% of the nail plate was affected by the infection. Plasma levels of
terbinafine with MOB-015 were substantially lower than after oral
administration, reducing the risk of liver toxicities observed with oral
terbinafine.
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®, NewSkin®, Domeboro®, Fiber
Choice®and PediaCare®. Kerasal Nail®(Emtrix®or Nalox™ in certain
markets) is a leading OTC treatment of nail disorders in the U.S.,
Canada as well as in several markets in EU and 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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