For millions of onychomycosis sufferers, practical treatment options are limited. They are either largely ineffective or require higher doses associated with systemic risks.
Mycologic potency, ability to penetrate the nail, dual mode of action and safety profile give Luliconazole the promise of a revolutionary therapeutic.
Luliconazole: in a class of its own.
A new molecule in a class of antifungal agents known as the imidazoles, Luliconazole is an exceptionally powerful molecule against a wide range of pathogens including Trichophyton rubrum, Trichophyton mentagrophytes and yeasts.
What truly separates Topica’s high-concentration formulation of Luliconazole from other topical antifungals on the market or in development is the combination of the drug’s potency and its ability to readily cross the nail. Topica’s clinical development program will determine whether its formulation can concentrate in the nail bed at fungicidal levels and support clear nail growth.
Fungicidal potency plus fungistatic activity.
Luliconazole combines broad-spectrum fungicidal super-potency with extremely low-MIC-level and enduring fungistatic activity that may help prevent early reinfection in the critical post-treatment period.
In fact, Luliconazole has demonstrated complete fungal eradication within only 21 days in an in vitro-infected nail model and the ability in animal models to prevent reinfection of the skin for up to 4 months post-application. This novel dual mode of action promises a new standard of efficacy in the patient-friendly, topical treatment of onychomycosis.
Proven to rapidly penetrate the nail.
As a result of Luliconazole’s low binding affinity to keratin, the main component of the nail, the drug readily crosses the human nail, achieving fungicidal concentrations in the nail bed in as little as 7 days. Importantly, Luliconazole treats fungus directly at the site of infection – offering the potential for superior clinical outcomes.
Unique formulation, distinctive profile.
Topically administered in a fast-drying, cosmetically elegant solution, Topica’s patent-pending formulation has limited systemic absorption, potentially reducing the risk of severe adverse effects or drug-drug interactions seen with oral therapies. Consistent with expectations, Luliconazole was very well tolerated in the company’s phase 1/2a maximal use PK study.
Moreover, Luliconazole has demonstrated an exemplary safety profile with no serious adverse events reported in more than 8 million patients in Japan since the 2005 approval of Lulicon® (1% cream and solution) for the topical treatment of tinea infections of the skin.
1 Osborne, CS, Leitner, I, Favre, B and Ryder, NS. Antifungal drug response in an in vitro model of dermatophyte nail infection. Medical
Mycology. 2004;42:2,159-163.
2 Uchida K, Tanaka T and Yamaguchi H. Achievement of complete mycological cure by topical antifungal agent NND-502 in guinea pig model
of tinea pedis. Microbiology and Immunology. 2003;47:143-146.
3 Package inserts for Lamisil® and Sporonox®.
