STOCKHOLM, March 22, 2019 /PRNewswire/ -- Moberg Pharma
AB (OMX: MOB) has completed the recruitment of 452 patients with
onychomycosis (nail fungus) for the ongoing MOB-015 phase 3 study
in Europe. Two Phase 3-studies are
currently underway in North
America and Europe with
topline results expected in the fourth quarter of 2019 and the
second quarter of 2020 respectively.
Phase 3 studies for MOB-015 are progressing in Europe and North
America evaluating the efficacy and safety of MOB-015,
Moberg Pharma's proprietary topical formulation of terbinafine. The
primary endpoint for both trials is the proportion of subjects
achieving complete cure of their target nail at 52 weeks.
The enrollment to the European study has now been completed with
452 patients randomized at 48 sites in Europe. Topline results from the European
Phase 3 study are expected in the second quarter of 2020.
The North American study was fully enrolled in September 2019, with topline results expected in
the fourth quarter of 2019.
"Completing the Phase 3 enrollment for MOB-015 is truly an
important milestone. I am very grateful to the team for the hard
work in completing the recruitment for both studies. More than
5,000 patients have been screened to recruit 800+ patients in the
rigorous screening process, ultimately increasing the probability
of strong phase 3 results for MOB-015", says Peter Wolpert, Moberg Pharma's CEO
About MOB-015 and Onychomycosis
Approximately 10% of the general population suffer from
onychomycosis and a majority of those afflicted go untreated. The
global market opportunity is significant with more than hundred
million patients worldwide and a clear demand for products with a
better efficacy and safety profile. Moberg Pharma estimates the
peak sales potential for MOB-015 to be in the range of $250 - 500 million.
Moberg Pharma has entered two license agreements for the
commercialization of MOB-015 – with Bayer AG in Europe and Cipher Pharmaceuticals in
Canada. MOB-015 is currently being
evaluated in more than 800 patients in two randomized, multicenter,
controlled Phase 3 studies in North
America and Europe. The
primary endpoint in both studies is the proportion of patients
achieving complete cure of their target nail over 52 weeks.
MOB-015 is an internally developed topical formulation of
terbinafine based on Moberg Pharma's experience from developing a
leading OTC product in the category. Oral terbinafine is currently
the gold standard for treating onychomycosis but associated with
risk for safety issues, including drug interactions and liver
damage. For many years, developing a topical terbinafine treatment
without the safety risks 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, in patients with severely affected
nails, MOB-015 demonstrated delivery of high microgram levels of
terbinafine through the nail plate into the nail bed as well as
into the nail, excellent mycological cure rates and clear nail
growth. Plasma levels of terbinafine with MOB-015 were
substantially lower than after oral administration, reducing the
risk of liver toxicities observed with oral terbinafine.
For additional information, please contact:
Peter Wolpert
CEO
telephone: +1-908-432-2203
e-mail: peter.wolpert@mobergpharma.se
Eleonora Stern-Nejman
Investor relations
phone: +46-701-76-22-42
e-mail: eleonora.stern-nejman@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
a.m. CET on March 22nd,
2019.
This information was brought to you by Cision
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Moberg Pharma
completes enrollment for MOB-015 Phase 3 study in Europe
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SOURCE Moberg Pharma