Topica Pharmaceuticals Initiates Phase 2b/3 Study of Luliconazole in Patients With Onychomycosis of the Toenails
Published: Jun 27, 2012
LOS ALTOS, CA--(Marketwire - June 27, 2012) - TOPICA Pharmaceuticals, Inc., a privately held biotechnology company, today announced the initiation of enrollment of the first patient in the SOLUTION study, a Phase 2b/3 trial that is evaluating 10% Luliconazole Solution in adults with mild-to-moderate distal subungual onychomycosis (DSO) of the toenails. The company also announced that it has been issued two new U.S. patents covering its anti-fungal 10% Luliconazole Solution.
The SOLUTION study will assess the safety and efficacy of 10% Luliconazole Solution in two dosing regimens applied for 48 weeks. Efficacy in the trial will be measured at week 52 by the composite endpoint of complete cure, which measures fungal eradication and complete clearance of the nail. TOPICA expects to enroll approximately 300 patients with mild-to-moderate DSO of the toenail at approximately 20 centers in the U.S.
"Enrolling the first patient into the SOLUTION study is a great accomplishment for TOPICA. This would not have been possible without the diligent input of our Scientific Advisory Board and the outstanding group of clinical investigators and sites participating in the study," said Amir Tavakkol, Ph.D., senior vice president of clinical development and operations at TOPICA. "We look forward to working closely with our investigative sites to complete this important study."
"Initiation of this trial is important for both patients and physicians as there is a significant need for access to a highly effective topical treatment for onychomycosis," said Richard Pollak, D.P.M., M.S., co-lead investigator of the SOLUTION study and assistant clinical professor, University of Texas, Health Science Center in San Antonio.
"Millions of Americans suffer from DSO, a chronic and frustrating disorder for which current treatment options are limited," said Linda Stein Gold, M.D., co-lead investigator of the SOLUTION study from Henry Ford Hospital in Detroit. "The advancement of the clinical development program for 10% Luliconazole Solution, which has shown great promise to date, into the Phase 2b/3 SOLUTION trial is a step forward for patients."
On June 5, 2012, the company was issued two new U.S. patents (8,193,232 and 8,193,233), which cover its anti-fungal formulations and methods of use for 10% Luliconazole Solution for the treatment of onychomycosis.
"We now have robust patent protection for luliconazole in the treatment of onychomycosis through these two new patents along with the issued composition of matter patent and other licensed formulations patents and patent applications," said Greg Vontz, president and chief executive officer of TOPICA. Morrison & Foerster's Palo Alto Intellectual Property Group advised the company on the prosecution and issuance of the newly issued U.S. patents.
About the SOLUTION Study
The SOLUTION study is a randomized, double-blind, vehicle-controlled, multicenter trial. The primary endpoint of the trial is the number and percentage of patients achieving complete cure at week 52. Complete cure is a combined endpoint of clear nail based on clinical assessment and a fungal eradication assessment by KOH (potassium hydroxide staining) and mycologic culture. Complete cure is the primary clinical endpoint defined by the U.S. Food and Drug Administration (FDA) for the conduct of pivotal clinical trials of antifungal products seeking FDA approval for onychomycosis. For more information on 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. 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 concentrations needed to eradicate the dermatophytes that most commonly cause onychomycosis. Based on the company's preclinical data and the results of the company's Phase 1/2a study of 10% Luliconazole Solution, luliconazole 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 one of the leading topical anti-fungal prescription products for tinea infections.
More than 35 million Americans 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 therapy for the treatment of onychomycosis. For more information, please visit http://www.topicapharma.com.