LOS ALTOS, CA--(Marketwire - March 19, 2012) - TOPICA Pharmaceuticals, Inc., a privately held biotechnology company, today announced promising results from its Phase 1/2a trial evaluating the safety, tolerability, systemic exposure and pharmacokinetics of a 10 percent solution of luliconazole after maximal use topical application in adults with moderate-to-severe distal subungual onychomycosis (DSO) of the toenails. The data were presented in a poster session during the 70th American Academy of Dermatology (AAD) Annual Meeting in San Diego.
"We are encouraged by the findings from our Phase 1/2a study, which demonstrate that our formulation of luliconazole is safe and well tolerated. These results set the stage for our pivotal Phase 2b/3 trial, which will begin mid-year," said Amir Tavakkol, Ph.D., senior vice president of clinical development and operations at TOPICA.
The poster, titled "Results of a Phase 1/2a Maximal Use Pharmacokinetic (PK) Study of Luliconazole Solution, 10% in Subjects with Moderate to Severe Distal Subungual Onychomycosis (DSO)," was presented at the AAD meeting by the lead investigator Terry M. Jones, M.D., a dermatologist in College Station, Texas. Study results showed that the 10 percent luliconazole solution resulted in very low systemic absorption and was well tolerated. In addition, all of the 24 patients enrolled in the study completed the trial and experienced excellent local tolerability, no laboratory abnormalities and no evidence of drug-induced cardiac abnormalities.
TOPICA plans to initiate a Phase 2b/3 clinical trial of approximately 300 patients with mild-to-moderate distal subungual onychomycosis of the toenail in mid-2012. The trial will involve approximately 20 centers in the U.S. It will assess the safety and efficacy of the 10 percent luliconazole solution in two dosing regimens applied for 48 weeks and will evaluate the impact of luliconazole on fungal eradication and clear nail growth. The primary endpoint of the trial will be 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 negative fungal assessment by KOH (potassium hydroxide staining) and mycologic culture. Complete cure is the primary clinical endpoint for the conduct of pivotal clinical trials seeking U.S. Food and Drug Administration approval. For more information on the Phase 2b/3 trial 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 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. The preclinical and clinical profile of luliconazole 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 in 1 percent 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 now focused on conducting a robust dose finding and proof of efficacy study with luliconazole in onychomycosis starting in mid-2012 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.