PALO ALTO, CA--(Marketwire - January 11, 2011) - TOPICA Pharmaceuticals, Inc., a privately-held biotechnology company, today announced enrollment of the first patient in a Phase 1/2a trial of luliconazole in patients with onychomycosis (nail and nail bed fungal infections). Luliconazole has been identified in preclinical studies as one of the most powerful antifungal agents against the major pathogens of onychomycosis and as having a unique pharmacokinetic profile that allows topical application to reach the infection site at highly therapeutic levels.
"The initiation of our Phase 1/2a luliconazole trial is a significant achievement for TOPICA. Not only does it represent the first step in our new strategy of developing the drug exclusively for onychomycosis, a difficult-to-treat condition that affects 35 million Americans, but it takes us closer to bringing the first highly effective and safe topical therapy for onychomycosis to market," said Greg Vontz, President and Chief Executive Officer of TOPICA. "Following the completion of the Phase 1/2a trial, we expect to initiate a robust Phase 2 proof-of-efficacy study mid-year."
In September 2010, TOPICA announced that it had entered into a sublicense and purchase option agreement with an undisclosed partner to develop luliconazole exclusively for tinea infections of the skin in the Americas and Europe. In conjunction with the sublicensing agreement, the company is now focusing on developing luliconazole for the treatment of onychomycosis.
Phase 1/2a Trial Design
The Phase 1/2a open-label, single-site study is evaluating the safety, tolerability, pharmacokinetics and accumulation of a 10 percent concentration of luliconazole in the nail after topical application in adults with moderate to severe distal subungual onychomycosis of the toenails. The trial will enroll approximately 20 patients who will receive once-daily applications of a maximal dose of luliconazole solution in the clinic for 28 days. The trial is being led by Dr. Terry M. Jones, a dermatologist in College Station, Texas. It is expected to be completed in March 2011. Additional information about the trial can be found at
"Over the years, patients with onychomycosis have tried a number of treatments to rid themselves of this condition, from home remedies to topical ointments to oral prescription antifungal medications. But the disease is so difficult to treat that oral medications are successful in clearing the nail only about one-third of the time and are associated with risk of serious liver toxicity, requiring liver function monitoring. Topical treatments that are currently available are effective in 10 percent or less of patients. As a result of the limited desirable treatment options for onychomycosis, there is a need for a highly effective, safe and convenient topical therapy for onychomycosis," said Dr. Jones. "Preclinical studies have shown that luliconazole permeates into the toenail and achieves full fungal eradication in less than a month, suggesting that it has the potential to be a highly effective topical therapy. I am pleased to be conducting the first human study of luliconazole to treat toenail fungus."
Following the conclusion of the Phase 1/2a luliconazole trial, TOPICA will enter into a Phase 2 proof-of-efficacy trial. The Phase 2 trial will enroll approximately 110 patients with mild to moderate distal subungual onychomycosis and will evaluate the impact of luliconazole on clear nail growth and fungal eradication. The trial will involve 8 to 10 leading onychomycosis clinical research sites in the United States.
Onychomycosis is an infection of the nail caused primarily by dermatophytes, a group of fungi. It is characterized by separation of the nail plate from the nail bed and changes in the nail plate, including thickening, changes in color, and the nail becoming very brittle. The nail can become discolored and painful as a result of the infection. Debris may collect beneath the nail plate, white marks frequently appear on the nail plate, and the infection is capable of spreading to other toenails, the skin or the fingernails. Onychomycosis is the most common nail disorder in adults, affecting 10 percent of the adult population. Those who suffer from chronic diseases, including diabetes, circulatory problems or immune-deficiency conditions, are especially prone to the disease. Currently approved therapies are either marginally effective or are complicated by the potential of liver toxicity and require hepatic monitoring.
Luliconazole is one of the most potent and broad-spectrum topical antifungal agents. In numerous, rigorous preclinical models of onychomycosis, luliconazole has demonstrated rapid penetration and therapeutic levels sufficient for fungal eradication in the nail bed. This preclinical profile suggests that luliconazole has the potential to be the first effective and safe topical therapy for onychomycosis. The potential annual U.S. market for onychomycosis treatment is estimated at approximately $3 billion. TOPICA has an exclusive license from Nihon Nohyaku Co., Ltd. to develop and market luliconazole for onychomycosis in the Americas and Europe.
Luliconazole was approved in Japan in 2005 for the treatment of tinea infections of the skin. To date more than 5 million patients have been treated with the product in Japan where luliconazole is one of the leading topical anti-fungal prescription products.
About TOPICA Pharmaceuticals, Inc.
TOPICA Pharmaceuticals, Inc. is a privately-held specialty pharmaceutical company focused on developing topical prescription products to treat the needs of patients with serious nail and skin conditions. TOPICA is developing luliconazole for the treatment of onychomycosis (nail and nail bed fungal infections) and is exploring the company's rights to develop luliconazole for the treatment of mucosal candidiasis (fungal infections caused by yeast, including oral thrush and vaginitis). For more information, please visit http://www.topicapharma.com.