TOPICA Presents Interim Safety and Mycologic Results from Its Phase 2b/3 Onychomycosis Trial of 10% Luliconazole Solution at the Interscience Conference on Antimicrobial Agents and Chemotherapy “SOLUTION” Study Update Shows That 10% Luliconazole Solution Has a Promising Safety and Mycologic Profile Business Wire DENVER & LOS ALTOS, Calif. -- September 10, 2013 TOPICA Pharmaceuticals, Inc., a privately held biotechnology company, today announced interim safety and mycologic susceptibility results from the ongoing Phase 2b/3 SOLUTION Study evaluating 10% Luliconazole Solution. With 334 patients enrolled in the clinical trial and approximately 50 patients having completed the study’s protocol at week 52, Luliconazole Solution is very well tolerated topically and shows no signs of systemic side effects at this point in the trial. As part of the SOLUTION Study, clinical isolates were collected from 184 patients in the study and tested for mycologic susceptibility to TOPICA’s 10% Luliconazole Solution at the Fungal Testing Laboratory at The University of Texas Health Science Center at San Antonio, Texas. When clinical isolates (96.2 percent were T. rubrum) collected from patients participating in the SOLUTION Study were tested, luliconazole had a minimum inhibitory concentration (MIC90) of 0.0005 µg/ml, confirming that the molecule is the most potent anti-fungal against the relevant fungi that cause onychomycosis. The data were presented during a poster session at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver. “The blinded data show that when the active or vehicle control have been applied for up to 48 weeks in either of the two dosing regimens being evaluated by the clinical trial, they exhibit excellent local tolerability, a good clinical laboratory safety profile and an unremarkable safety profile based on the number of reported adverse events to date in the study. The safety profile and the mycologic susceptibility results are very encouraging,” said Amir Tavakkol, Ph.D., senior vice president of clinical development and operations at TOPICA. “We look forward to sharing the final results from the SOLUTION Study in the second half of 2014 when the trial has been unblinded.” The SOLUTION Study is a randomized, double-blinded, 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. Enrollment was completed in June 2013. As of August 30, 2013, 334 subjects had been randomized and approximately half of the patients have participated in the trial for six months. TOPICA expects to report full results from the trial in the second half of 2014. “Of the 32 million U.S. onychomycosis patients, less than 3 million patients are currently being treated due to the side-effect profile or limited efficacy of the FDA-approved drugs currently available. A highly effective, safe and convenient new treatment is a significant need for the millions of onychomycosis sufferers,” said Greg Vontz, president and chief executive officer of TOPICA. “We believe, based on our preclinical, Phase 1/2a studies and now these interim results, that luliconazole may have the potential to meet this significant unmet clinical need. If the final results are positive, our plan is to identify a partner with global development and commercialization abilities to take the program through Phase 3 development and commercialization in the Americas and the EU.” About the SOLUTION Study 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 SOLUTION Study was designed to evaluate two dosing regimens of 10% Luliconazole Solution in patients with mild-to-moderate distal subungual onychomycosis of the toenails. 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. 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 MIC90 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 MIC90 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%) suggest 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 Approximately 32 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, or 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. Contact: BrewLife Joey Fleury, 415-946-1090 firstname.lastname@example.org
TOPICA Presents Interim Safety and Mycologic Results from Its Phase 2b/3 Onychomycosis Trial of 10% Luliconazole Solution at the
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