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
“SOLUTION” Study Update Shows That 10% Luliconazole Solution Has a Promising
Safety and Mycologic Profile
DENVER & LOS ALTOS, Calif. -- September 10, 2013
TOPICA 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 treated 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
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 onychomycosis.
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 @TopicaPharma.
Joey Fleury, 415-946-1090
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