SOURCE: TOPICA Pharmaceuticals

TOPICA Pharmaceuticals

June 12, 2013 08:00 ET

TOPICA Announces Completion of Enrollment in Its Phase 2b/3 Onychomycosis Trial of 10% Luliconazole Solution

LOS ALTOS, CA--(Marketwired - Jun 12, 2013) - 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 2014.

"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 them 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 clinicaltrials.gov at http://clinicaltrials.gov/ct2/show/NCT01431820?term=topica&rank=1

About Luliconazole
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 scientific literature.

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.

About Onychomycosis
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 @TopicaPharma.

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