Topica Pharmaceuticals Announces 10% Luliconazole Program Ready For Phase 3 Development For Onychomycosis Based On Positive Phase 2 Results

LOS ALTOS, Calif.--(BUSINESS WIRE)--TOPICA Pharmaceuticals, Inc., a privately held biotechnology company, today announced that it’s ready to advance its 10% solution of luliconazole into Phase 3 development based on positive results from its Phase 2 SOLUTION Study. The Company met with the FDA for an End of Phase 2 Meeting to discuss the company’s future Phase 3 plans and has determined that no additional pre-clinical work is necessary to support a New Drug Application. Based on the Phase 2 trial results and the positive End of Phase 2 Meeting, Topica is seeking a partner to advance 10% luliconazole into Phase 3 studies to pursue approval in its licensed territories of the Americas and Europe.

“Based on luliconazole’s superior antifungal potency and our Phase 2 results compared to recently approved products, we believe that luliconazole has the potential to be a best-in-class topical treatment for onychomycosis.”

“The Phase 2 study was designed to assess the safety and efficacy of 10% luliconazole solution, select the optimal dosing regimen, and determine the Phase 3 development criteria to support approval and maximize the product’s competitive profile in the topical onychomycosis marketplace. We achieved all of these objectives and are looking forward to advancing the program into Phase 3 development,” said Greg Vontz, president and CEO of Topica Pharmaceuticals, Inc. “Based on luliconazole’s superior antifungal potency and our Phase 2 results compared to recently approved products, we believe that luliconazole has the potential to be a best-in-class topical treatment for onychomycosis.”

Luliconazole’s superior antifungal potency was highlighted by research presented at the 19th ISHAM (International Society of Human & Animal Mycology) Congress in May 2015 in Melbourne, Australia. The results of a head-to-head in-vitro antifungal potency study comparing luliconazole to efinaconazole showed that for the two most common dermatophytes (fungi) causing onychomycosis worldwide, (Trichophyton Rubrum and Trichophyton Mentagrophytes), luliconazole has considerably greater antifungal potency. The minimum fungicidal concentration required to eradicate 90% of T. Rubrum and T. Mentagrophytes with luliconazole was 0.0078 µg/mL for both strains vs 0.50 µg/mL and 0.25 µg/mL for efinaconazole respectively. These findings demonstrated luliconazole’s approximately 30 – 60 times greater antifungal potency advantage over the current topical onychomycosis treatment market leader, efinaconazole.

About the SOLUTION Study

Topica’s SOLUTION Study enrolled 334 patients at 28 clinical research sites across the U.S. Study participants were randomized (2:2:1:1) to one of four arms: 10% luliconazole applied once daily for 48 weeks, 10% luliconazole applied once daily for 12 weeks followed by once weekly treatment for 36 weeks, or one of two matched vehicle control arms. The primary endpoint was complete cure at week 52, which is the same endpoint used in recent Phase 3 trials to support FDA approval.

About Luliconazole

Luliconazole is the most potent and broad-spectrum topical antifungal agent against the most common fungal strains that cause infections of the skin and nails worldwide. It is approximately 30 times stronger against the key fungi that cause onychomycosis than any drug approved in the U.S. Luliconazole was first approved in Japan in 2005 for the treatment of fungal infections of the skin. Since then, it has become the number one most prescribed topical treatment for fungal infections of the skin in Japan. Luliconazole was approved in the U.S. in 2013 and is currently marketed by Valeant Pharmaceuticals under the brand name LUZU^® (1% luliconazole cream). Luliconazole’s excellent mycologic profile in fungal infections of the skin has made it a natural choice for development in onychomycosis. The preclinical and clinical profile of luliconazole observed in Phase 1 and Phase 2 trials, suggests that it has the potential to be a safe and effective 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.

About Onychomycosis

More than 32 million Americans are estimated to suffer from onychomycosis, fungal infections of the nail. The potential annual U.S. market for onychomycosis treatment is estimated at approximately $3 billion, however until recently, treatments have been limited. With the recent approval of two new topical therapies for the treatment of onychomycosis, direct-to-consumer advertising targeting physicians and patients, as well as directed promotional activities, the prescription market has rapidly expanded and is projected to grow to more than 10 million patients annually. Further innovation and advances in the treatment of onychomycosis topically are expected to further expand the market.

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 seeking a partner for Phase 3 development and commercialization of 10% luliconazole solution for the treatment of onychomycosis in its exclusively licensed territories of the Americas and Europe. For more information, please visit http://www.topicapharma.com or contact the company at info@topicapharma.com.