Ring worm of the nail (onychomycosis) drug luliconazole may go on clinical trials this year: Topica

Ring worm of the nail (onychomycosis) drug luliconazole may go on clinical trials this year: Topica

Luliconazole, a potential anti-fungal treatment against the common ring worm of the nail (onychomycosis), has been granted approval to conduct clinical studies in US, according to Topica Pharmaceuticals.

The U.S. Food and Drug Administration has accepted Topica’s Investigational New Drug (IND) application for the use of luliconazole in patients with onychomycosis (nail and nail bed fungal infections).

Luliconazole is one of the most potent and broad-spectrum topical antifungal agents.

Topica plans to initiate a Phase 1/2 trial in the first quarter.

The Phase 1/2 trial will be conducted in patients with moderate to severe distal subungual onychomycosis and will evaluate 28 days of treatment with luliconazole 10% solution given once daily.

The safety, tolerability and pharmacokinetic profile of the luliconazole will be assessed.  Patients will also be followed post treatment for 30, 60, and 90 days assessing the concentration of luliconazole in the infected nails, mycologic effectiveness and amount of new clear nail growth.

“If approved, it [luliconazole] will provide a new treatment option for this prevalent and difficult-to-treat condition,” said David Cohen, M.D., M.P.H., a leading dermatologist and Vice Chairman for Clinical Affairs at the New York University School of Medicine Department of Dermatology.

Onychomycosis affects approximately 35 million people in the U.S.

Some of the currently approved therapies for onychomycosis have the potential of liver toxicity and require hepatic monitoring.

In preclinical models of onychomycosis, luliconazole has demonstrated rapid penetration and therapeutically effectively levels in the nail bed.

The potential annual U.S. market for onychomycosis treatment is estimated at approximately $3 billion.

Topica is also developing luliconazole for the treatment of tinea pedis,

the most common fungal infection of the skin, affecting about one in every 10 people. In the U.S. more than 22 million prescriptions are written annually for tinea infections.

Currently approved products for the topical treatment of tinea pedis are only modestly effective, have a high reoccurrence rate and require a month of therapy.

In 2009, Topica announced positive results from its Phase 2 clinical trial of luliconazole for tinea pedis.  The results of Topica’s Phase 2 trial demonstrated that luliconazole was substantially more effective than approved therapies and required half the treatment time. Topica expects to begin its pivotal Phase 3 trials in 2010 to support approval.

Topica has an exclusive license from Nihon Nohyaku Co., Ltd. to develop and market luliconazole in the Americas and Europe.

Luliconazole (Lulifin) has been launched in Indian market by Daiichi-Ranbaxy in January.

Luliconazole (Lulifin) has been brought to India through a strategic in-licensing agreement with Summit Pharmaceuticals International Corporation, Japan (SPI).

The partnership allows Ranbaxy to have exclusive marketing rights for Luliconazole (Lulifin) in India.

Topica is a privately-held specialty pharmaceutical company focused on licensing, developing and commercializing topical prescription products to treat the needs of patients with serious nail and skin conditions.

Topica has in-licensed its lead product candidate, luliconazole, that is already on the market in Japan.