STOCKHOLM, Dec. 12, 2019 /PRNewswire/ -- Moberg Pharma AB
(OMX: MOB): On Monday the topline results were presented
from the first study in the Phase 3 program for MOB-015, where the
primary endpoint and the two key secondary endpoints were met.
Since the results are somewhat contradictory and the company has
received many questions, we want to clarify the various study
parameters as well as our view of the current status and next
step.
The company's comment on the results
On Monday December 9th,
the topline results were presented from the first of two clinical
studies in the Phase 3 program for MOB-015. The primary endpoint
was met and provided that the second study also produces positive
results, both studies could form a basis to register the product.
However, the outcome of the first study as a whole is more
difficult to interpret.
Treatment of onychomycosis involves two main parameters: curing
the fungal infection (mycological cure) and restoring the nail's
normal appearance (clinical cure), where the former is objectively
determined through laboratory results and the latter is determined
subjectively by the investigators. The fact that MOB-015 achieved
mycological cure in 70 percent of the patients in this study is
exceptional and exceeded our expectations. The study also showed
that MOB-015 significantly outperformed the
vehicle[1] for the key endpoints and confirmed the
product's ability to rapidly achieve visible improvement. Already
by the first follow-up visit, 83 percent of the patients reported
improvement. The investigators' clinical assessment of the nails'
appearance was not as positive, however.
The outcome of the study is surprising, since a high mycological
cure is normally over time followed by normalization of the nail's
appearance.
In collaboration with leading experts, the company is now fully
engaged in reviewing the study results in detail, including all
nail photos, to better understand the reasons for the outcome. We
also expect further insight from the ongoing European study, where
MOB-015 is being compared to the most commonly used topical
treatment. Lessons learned from both studies can later be used to
optimize how the product will be used.
It is too early to draw any firm conclusions from the first
study in the Phase 3 program. The company plans to provide an
update once additional information is available.
Definitions of endpoints and topline results
Complete cure - Primary endpoint
The primary endpoint in the study is complete cure at week 52,
which is a composite measure of mycological cure and
clinical cure. The primary endpoint was met, since
significantly more patients in the MOB-015 group - 4.5 percent -
reached complete cure compared to none in the control group
(p=0.019).
Mycological cure
Mycological cure is an objective measure composed of two laboratory
results: fungal culture and KOH microscopy. The physician/nurse
takes nail clippings, which are sent to a central laboratory for
analysis. If fungus cannot be cultured from the sample and fungal
elements subsequently cannot be seen in a microscopic examination,
the nail is mycologically cured (fungus free). A 70 percent
mycological cure after one year is remarkably high for a topical
treatment and on par with the best oral treatment. Mycological cure
is defined in the study as a key secondary endpoint.
Clinical cure
Clinical cure is a subjective measure where an experienced
physician at each clinic performs a visual assessment of how much
of the nail is affected by onychomycosis. No signs of infection
should be visible on the nail to achieve complete cure. This
endpoint is difficult to determine and takes different lengths of
time to achieve for different nails, depending among other things
on the condition of the nail at treatment start. Data for clinical
cure has not yet been reported, since it was not included in the
initial topline data but will be delivered in the complete data
package.
Treatment success
Since the difficulty in achieving complete cure in 52 weeks is well
known, Treatment success is also reported, a composite measure of
mycological cure combined with a clinical assessment that the nail
should be clear or almost clear (up to 10 percent affected nail
area). Treatment success was reached in 15.4 percent of the
patients and was significantly better than the control group
(p=0.0018). Treatment success is defined in the study as a key
secondary endpoint.
The patient's own assessment
The patient's own assessment is a subjective measure where the
patient assesses the improvement in the nail according to a
standardized scale. Of the patients who completed the study, 33
percent reported that their treated toenails were completely cured
or almost cured. In addition, 83 percent of the patients reported a
visible improvement after just twelve weeks of treatment.
About the Phase 3 study in North
America
The recently completed Phase 3 study was conducted at 32 sites in
the U.S. and Canada and included a
total of 365 patients, 246 of whom received MOB-015 and 119 who
were in the control group and received the vehicle. The patients
had at least one great toenail that was 20-60 percent affected.
Treatment was administered once daily for 48 weeks and patients
were followed up for a total of 52 weeks. A second Phase 3 study is
currently underway in Europe
comprising 452 patients and is expected to be finalized in spring
2020.
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 December 12th,
2019.
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.
MOB-015 is currently being 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 in both studies is the proportion of patients
achieving complete cure of their target nail. Topline results from
the North American study are now available, followed by results in
Europe expected in the second
quarter of 2020.
[1] Vehicle - The MOB-015 product without its active
substance, terbinafine
For additional information, please contact:
Anna Ljung, CEO, telephone:
+46 707 66 60 30, E-mail: anna.ljung@mobergpharma.se
Peter Wolpert, Executive Chairman,
telephone: US: +1 908 432 2203,
e-mail: peter.wolpert@mobergpharma.se
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Moberg Pharma
comments on the results of the North American Phase 3 study with
MOB-015
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SOURCE Moberg Pharma