TOPICA Announces Completion of Enrollment in Its Phase 2b/3 Onychomycosis Trial
of 10% Luliconazole Solution
LOS ALTOS, CA -- (Marketwired) -- 06/12/13 -- TOPICA
Pharmaceuticals, Inc., a privately held biotechnology company, today
announced completion of enrollment in The "SOLUTION" Study, a
300-patient Phase 2b/3 clinical trial being conducted by the company.
The clinical trial is a randomized, double-blind, 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.
TOPICA expects to report results from the trial in the second half of
"The completion of enrollment in this trial sets an exciting course
for our product to potentially revolutionize the treatment of
onychomycosis based on the potency of the molecule and a topical
regimen that may be very safe, as well as convenient," said Greg
Vontz, president and chief executive officer of TOPICA. "If the
results are in line with company expectations, we will be seeking a
partner to take the program through Phase 3, approval and
commercialization in our exclusively licensed territories of the
Americas and the EU."
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 trial was designed to evaluate two dosing
regimens of 10% Luliconazole Solution. 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.
"It is impressive how quickly and efficiently our investigative sites
have completed enrollment in the SOLUTION study. We look forward to
continuing to collaborate with the
m to complete and report the
results," said Amir Tavakkol, Ph.D., senior vice president of
Clinical Development and Operations at TOPICA. "Our 10% Luliconazole
Solution is cosmetically elegant, simple to use and dries rapidly
with little to no residue. Based on the safety and pharmacokinetic
profile of 10% Luliconazole Solution observed in our Phase 1/2a
trial, robust in vitro nail penetration and permeation profile and
potency seen in preclinical studies, we believe luliconazole has the
potential to significantly improve upon the existing and pending
topical treatments for onychomycosis."
For more information about the SOLUTION study visit
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 MIC 90
for these key dermatophytes than antifungals currently in development
such as efinaconazole and tavaborole based on their published
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 MIC 90 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%) suggests 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.
An estimated 35 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, 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
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