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IVR101/2 – Topical Antifungal Onychomychosis

Indication

Onychomycosis is a fungal infection that causes toenails and sometimes fingernails to discolor, thicken, and disfigure. Aging of the population, ill-vented shoes, locker room exposure and different strains of fungi are believed to contribute to increased prevalence of onychomycosis, especially in younger adults. Onychomycosis starts as a cosmetic concern. Without proper treatment, however, the nails can become so thick that they press against the inside of footwear, causing pain and irritation. In certain patients onychomycosis can act as a portal for bacterial infections.

Onychomycosis is treated by prescription doses of either topical or oral medications. Because nails grow slowly, it takes up to a year for the nail to regain a healthy, clear, thin appearance with either topical or oral treatments when successful. Additionally, patients frequently suffer reoccurrences of the infection.

Topical treatments consist of daily applications of a nail lacquer for a period of several months. The fungicidal active ingredients in theses lacquers must pass through the nail to reach the targeted fungus. Lacquers, however, tend to quickly dry on the surface of the nail and very small amounts of the active ingredient actually reach the fungus. Lacquers also build up on the nail surface and at intervals must be removed using chemical solvents before treatment can continue. Organic materials in the lacquer may also irritate surrounding skin. Consequently, the success of treatment of onychomycosis with nail lacquers has been marginal for physicians and disappointing to patients.

Oral medications for the treatment of onychomycosis are also administered over a period of several months. These medications have a higher success rates than topical medications but are not recommended for patients with certain conditions or diseases. Commencement and continuing use of oral medications for onychomycosis should be closely monitored by a physician. Long term use of oral medications for onychomycosis is not recommended. Certain oral medications have been associated with liver problems, with serious allergic reactions, and with interactions with other drugs the patient might be taking.

Product Profile

Ivrea Pharmaceuticals seeks to achieve the efficacy of oral medications and the safety of topical applications for the successful treatment of onychomycosis. IVR 101/102 are topically applied gels which deliver fungicidal active ingredients efficiently through the nail to the site of the fungal infection. Ivrea Pharmaceuticals' proprietary gels have demonstrated the ability to rapidly deliver fungus-killing concentrations of drug through the nail. And because our products are gel-based, they do not build-up layers of lacquer on the nail. Our gels are also less likely to cause irritation to the surrounding skin when compared to multiple applications of lacquers. By combining our proprietary gels with known highly-active fungicidal ingredients, Ivrea seeks to create unique prescription products that offer an unparalleled combination of efficacy, safety and convenience for the treatment of onychomycosis.

 

Clinical Pipeline

Ivrea is developing topically applied gels for the treatment of onychomycosis. In later stages of clinical development, IVR 101/102 are intended to offer the safety of topical application while simultaneously providing the efficacy associated with oral medications. Compared to lacquers, our gels are also less likely to cause irritation to the surrounding skin.

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