|[September 10, 2013]
TOPICA Presents Interim Safety and Mycologic Results from Its Phase 2b/3 Onychomycosis Trial of 10% Luliconazole Solution at the Interscience Conference on Antimicrobial Agents and Chemotherapy
DENVER & LOS ALTOS, Calif. --(Business Wire)--
Pharmaceuticals, Inc., a privately held biotechnology company, today
announced interim safety and mycologic susceptibility results from the
ongoing Phase 2b/3 SOLUTION Study evaluating 10% Luliconazole Solution.
With 334 patients enrolled in the clinical trial and approximately 50
patients having completed the study's protocol at week 52, Luliconazole
Solution is very well tolerated topically and shows no signs of systemic
side effects at this point in the trial.
As part of the SOLUTION Study, clinical isolates were collected from 184
patients in the study and tested for mycologic susceptibility to
TOPICA's 10% Luliconazole Solution at the Fungal Testing Laboratory at
The University of Texas Health Science Center at San Antonio, Texas.
When clinical isolates (96.2 percent were T. rubrum) collected
from patients participating in the SOLUTION Study were tested,
luliconazole had a minimum inhibitory concentration (MIC90) of 0.0005
µg/ml, confirming that the molecule is the most potent anti-fungal
against the relevant fungi that cause onychomycosis. The data were
presented during a poster session at the 53rd Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC) in Denver.
"The blinded data show that when the active or vehicle control have been
applied for up to 48 weeks in either of the two dosing regimens being
evaluated by the clinical trial, they exhibit excellent local
tolerability, a good clinical laboratory safety profile and an
unremarkable safety profile based on the number of reported adverse
events to date in the study. The safety profile and the mycologic
susceptibility results are very encouraging," said Amir Tavakkol, Ph.D.,
senior vice president of clinical development and operations at TOPICA.
"We look forward to sharing the final results from the SOLUTION Study in
the second half of 2014 when the trial has been unblinded."
The SOLUTION Study is a randomized, double-blinded, vehicle-controlled,
U.S. multicenter trial assessing the safety and efficacy of 10%
Luliconazole Solution in two dosing regimens in patients with
mild-to-moderate distal subungual onychomycosis of the toenails.
Enrollment was completed in June 2013. As of August 30, 2013, 334
subjects had been randomized and approximately half of the patients have
participated in the trial for six months. TOPICA expects to report full
results from the trial in the second half of 2014.
"Of the 32 million U.S. onychomycosis patients, less than 3 million
patients are currently being reated due to the side-effect profile or
limited efficacy of the FDA-approved drugs currently available. A highly
effective, safe and convenient new treatment is a significant need for
the millions of onychomycosis sufferers," said Greg Vontz, president and
chief executive officer of TOPICA. "We believe, based on our
preclinical, Phase 1/2a studies and now these interim results, that
luliconazole may have the potential to meet this significant unmet
clinical need. If the final results are positive, our plan is to
identify a partner with global development and commercialization
abilities to take the program through Phase 3 development and
commercialization in the Americas and the EU."
About the SOLUTION Study
Based on the favorable nail and plasma pharmacokinetic profile of 10%
Luliconazole Solution seen in the company's Phase 1/2a trial, TOPICA's
Phase 2b/3 SOLUTION Study was designed to evaluate two dosing regimens
of 10% Luliconazole Solution in patients with mild-to-moderate distal
subungual onychomycosis of the toenails. The first regimen is a
once-a-day application for 48 weeks, and the second regimen is a
once-a-day application for 12 weeks followed by a once-weekly
application for 36 weeks. Both dosing regimens will be assessed using
the primary endpoint of Complete Cure at week 52. Complete Cure is a
combined endpoint of clear nail based on the investigator's clinical
assessment and mycological cure as assessed by both a negative KOH
(potassium hydroxide staining) and negative mycologic culture. Complete
Cure is the primary efficacy endpoint in pivotal onychomycosis trials of
antifungal products seeking U.S. Food and Drug Administration approval
for marketing. For more information about the SOLUTION Study, visit
clinicaltrials.gov at http://clinicaltrials.gov/ct2/show/NCT01431820?term=topica&rank=1.
Luliconazole is one of the most potent and broad-spectrum topical
prescription antifungal agents known against the dermatophytes (T.
rubrum and T. mentagrophytes) that cause 90 percent of
onychomycosis. It is more potent against these pathogens than
terbinafine, amorolfine and ciclopirox based on head-to-head in vitro
comparisons. Luliconazole also has considerably lower MIC90 for these
key dermatophytes than antifungals currently in development, such as
efinaconazole and tavaborole, based on their published scientific
In numerous rigorous, preclinical models of onychomycosis, luliconazole
has demonstrated rapid penetration of full-thickness human toenails
(infected and healthy) reaching concentrations well in excess of the
MIC90 needed to eradicate the dermatophytes that most commonly cause
onychomycosis. A preclinical data set and clinical profile from the
company's Phase 1/2a study of Luliconazole Solution (10%) suggest that
it has the potential to be an effective and safe topical therapy for
TOPICA has an exclusive license from Nihon Nohyaku Co., Ltd. to develop
and market luliconazole for onychomycosis in the Americas and Europe.
Luliconazole 1% cream and solution formulations were approved in Japan
in 2005 for the treatment of tinea infections of the skin. To date, more
than 10 million patients have been treated with the product in Japan,
where luliconazole is the leading topical anti-fungal prescription
product for tinea infections.
TOPICA has three U.S. formulation and method of use patents approved for
its 10% Luliconazole Solution. These patents, in conjunction with the
composition of matter patent and licensed patents, are expected to
provide robust patent protection for the program through 2030.
Approximately 32 million patients in the United States and 10-12 percent
of adults worldwide are estimated to suffer from onychomycosis, for
which treatment options are limited. The potential annual U.S. market
for onychomycosis treatment is estimated at approximately $3 billion.
About TOPICA Pharmaceuticals, Inc.
TOPICA Pharmaceuticals, Inc. is a privately held clinical research stage
pharmaceutical company focused on developing luliconazole for the
treatment of onychomycosis, or fungal infections of the nail. The
company is focused on conducting the Phase 2b/3 SOLUTION Study, a robust
dose finding and proof of efficacy trial with luliconazole in
onychomycosis with the goal of making luliconazole the first highly
effective and safe topical treatment for onychomycosis. For more
information, please visit http://www.topicapharma.com
and follow the company on Twitter (News - Alert) @TopicaPharma.
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