STOCKHOLM, Oct. 14, 2020 /PRNewswire/ -- Moberg Pharma AB
(OMX: MOB) announced today its decision to request pre-submission
meetings with regulatory agencies, with the goal of submitting a
registration application in the second half of 2021 in Europe.
In June, Moberg Pharma presented topline results from the second
of two clinical Phase 3 studies for MOB-015. In the European study
- as well as in the North American study - the primary endpoint was
achieved and no serious adverse events were reported. MOB-015's
superior mycological cure (percentage of patients who were
fungus free) has now been demonstrated in two pivotal studies,
providing further support for the company's target to make MOB-015
the future market leader in onychomycosis. Moberg Pharma will now
finalize the documentation for the registration application which
the company expects to submit during the second half of 2021.
"After thorough analysis of the data with our scientific
advisors and partners, we see strong potential for MOB-015 and are
now through submission preparations pursuing the next key steps
toward market approval. There is great need for better topical
treatments with the ability to really cure the fungal infection.
The superior mycological cure enables a unique position for
MOB-015," says Anna Ljung,
CEO of Moberg Pharma.
After the European meetings, Moberg Pharma intends to
discuss next steps for the US market in an advice meeting with the
FDA.
About MOB-015 and Onychomycosis
Approximately 10 percent 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 better
products.
MOB-015 is an internally developed topical formulation of
terbinafine based on Moberg Pharma's experience from previously
having developed and commercialized a leading OTC product for
onychomycosis. Oral terbinafine is currently 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. Plasma levels of terbinafine with MOB-015
were substantially lower than after oral administration, reducing
the risk of liver toxicities observed with oral terbinafine.
Moberg Pharma has secured commercialization partners for MOB-015
in Europe, Japan, Canada
and the Republic of Korea.
MOB-015 has recently been evaluated over 52 weeks in two
randomized, multicenter, controlled Phase 3 studies, including in
total more than 800 patients in North
America and Europe. The
primary endpoint was met in both studies, the proportion of
patients achieving complete cure of their target nail. Mycological
cure (eradicating the fungal infection) was achieved in 70 percent
of the patients in the North American study and 84 percent of the
patients in the European study, which is substantially higher than
reported for other topical treatments.
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 persons set out above, at 8.00
a.m. CET on October
14th, 2020.
For additional information, please
contact:
Anna Ljung
CEO
telephone: +46-707-66-60-30
E-mail: anna.ljung@mobergpharma.se
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Moberg Pharma intends
to submit a registration application in Europe in 2021
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