Onychomycosis is a chronic fungal infection of the nails that affects approximately 40 million Americans. The infection, caused by dermatophytes such as Trichophyton rubrum, often results in painful thickening and deformation of the nail and sometimes separation of the nail plate from the nail bed, leading to an inability of the nail to perform its natural protective function. Oral therapies used to treat the infection are associated with severe side effects, and topical therapies have modest efficacy profiles with complete cure rates of less than 20%.
Novan is developing SB208 as a broad-spectrum anti-fungal gel for the treatment of fungal infections of the skin and nails, such as athlete’s foot and onychomycosis. The Phase 2 clinical program to evaluate the efficacy and safety of the Company’s topical nitric oxide product candidate SB208 in the treatment of infections caused by the Trichophyton rubrum (T. rubrum) has been initiated. Novan expects to report top-line results of this Phase 2 trial in the first half of 2017.
Novan has conducted in vitro studies to evaluate the anti-fungal activity of nitric oxide-releasing candidates against T. rubrum. In the ChubTur® infected human nail assay, a model utilized previously in the drug development of Kerydin® (tavaborole) Topical Solution, 5%, and Jublia® (efinaconazole) Topical Solution, 10%, T. rubrum was inoculated to the underside of human nails and allowed to establish infection. Several of Novan’s nitric oxide-releasing formulations were applied topically to the top of the infected nail plates to assess nail penetration and anti-fungal activity. All of the tested formulations demonstrated effective fungal killing on the underside of the nail in 24 hours following a single treatment application.
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