LOS ALTOS, CA--(Marketwired - Jun 12, 2013) - TOPICA Pharmaceuticals, Inc., a privately held biotechnology company, today announced completion of enrollment in The "SOLUTION" Study, a 300-patient Phase 2b/3 clinical trial being conducted by the company. The clinical trial is a randomized, double-blind, 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. TOPICA expects to report results from the trial in the second half of 2014.

"The completion of enrollment in this trial sets an exciting course for our product to potentially revolutionize the treatment of onychomycosis based on the potency of the molecule and a topical regimen that may be very safe, as well as convenient," said Greg Vontz, president and chief executive officer of TOPICA. "If the results are in line with company expectations, we will be seeking a partner to take the program through Phase 3, approval and commercialization in our exclusively licensed territories of the Americas and the EU."

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 trial was designed to evaluate two dosing regimens of 10% Luliconazole Solution. 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.

"It is impressive how quickly and efficiently our investigative sites have completed enrollment in the SOLUTION study. We look forward to continuing to collaborate with them to complete and report the results," said Amir Tavakkol, Ph.D., senior vice president of Clinical Development and Operations at TOPICA. "Our 10% Luliconazole Solution is cosmetically elegant, simple to use and dries rapidly with little to no residue. Based on the safety and pharmacokinetic profile of 10% Luliconazole Solution observed in our Phase 1/2a trial, robust in vitro nail penetration and permeation profile and potency seen in preclinical studies, we believe luliconazole has the potential to significantly improve upon the existing and pending topical treatments for onychomycosis."