STOCKHOLM, Dec. 9, 2019 /PRNewswire/ -- Moberg Pharma AB
(OMX: MOB) announces that MOB-015 (topical terbinafine) met the
primary endpoint as well as key secondary endpoints in the North
American Phase 3 study including 365 patients with mild to moderate
toenail onychomycosis (nail fungus). At week 52, significantly more
patients reached complete cure for MOB-015 than for vehicle
(p=0.019), following 48 weeks of daily treatment.
The purpose of this randomized, multicenter, controlled clinical
Phase 3 study was to evaluate the efficacy and safety
of MOB-015 in patients with mild to moderate distal subungual
onychomycosis (DSO) affecting 20-60 percent of the great toenail.
The study was conducted at 32 sites in the U.S. and Canada and included 365 patients, 246 patients
receiving MOB-015 and 119 patients receiving vehicle. Patients
received treatment during 48 weeks and had the last follow-up
assessment at week 52.
The primary endpoint, the proportion of patients achieving
complete cure of their target toenail at 52 weeks, was achieved in
4.5 percent of the patients for MOB-015 and in none of the patients
receiving vehicle (p=0.019). Complete cure is a composite endpoint
that requires both a completely clear nail and mycological
cure. Mycological cure, defined as both negative KOH and
negative dermatophyte culture, was achieved in 70 percent of the
patients (p<0.0001). Treatment success (mycological cure and
almost or completely clear great toenail) assessed by the
investigator was achieved in 15.4 percent of the patients (p=
0.0018). In the patients' self-assessments, a clear majority (83
percent) of the patients completing the study reported improvement
from MOB-015 as early as 12 weeks after starting treatment, and at
week 52, 33 percent reported their treated toenails were cured or
almost cured.
MOB-015 was generally well tolerated. The number of patients
with treatment related adverse events was similar for MOB-015 and
vehicle, and consistent with our past experience. No safety issues
were identified in the trial and no serious adverse events related
to MOB-015 were reported.
"The mycological cure rate in the study is remarkably high
for a topical treatment. We believe this is due to fungicidal
activity of terbinafine in MOB-015. We would normally expect more
patients reaching complete cure following eradication of the
infection in such a clear majority of the patients. This will be
further investigated and we expect additional insights from the
European study (n=452), in which MOB-015 is compared head to head
against the most widely used topical treatment. A safe, efficacious
topical terbinafine product eradicating the infection and
progressing healthy nail growth for many patients is highly
attractive for practicing physicians worldwide", stated
Amir Tavakkol, Senior Advisor
R&D at Moberg Pharma AB.
"To cure 70 percent of the patients from their fungal nail
infection is a superior result and better than expected for a
topical product. We were however expecting a higher complete cure
rate, following the high mycological cure, despite the well-known
challenges in demonstrating completely cleared nails at 52 weeks
even after the fungal infection is cured. The study confirms the
rapid visible improvement experienced by patients, where four out
of five patients reported some improvement already at the first
follow up visit, and at the end of the study, 33 percent of
patients rated their nail to be cured or almost cured", said
Anna Ljung, CEO of Moberg Pharma
AB.
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
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 9th,
2019.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/moberg-pharma/r/moberg-pharma-meets-primary-endpoint-for-mob-015-in-a-phase-3-study-for-the-treatment-of-onychomycos,c2984987
The following files are available for download:
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Moberg Pharma meets
primary endpoint for MOB-015 in a Phase 3 study for the treatment
of onychomycosis
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SOURCE Moberg Pharma