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 antifungal gel for the treatment of superficial cutaneous fungal infections of the skin and nails, such as tinea pedis and onychomycosis. In a Phase 2 clinical trial, SB208 Gel, at both the 4% and 16% concentrations, demonstrated a statistically significant effect (p<0.05) compared to vehicle in a clinical trial in patients with tinea pedis, or athlete’s foot.
- In the primary efficacy analysis of patients with evaluable culture results, 80.6% (p=0.002) of patients treated with SB208 4% and 74.2% (p=0.016) of patients treated with SB208 16% achieved negative fungal culture at day 14 versus 45.5% of patients treated with vehicle.
- The percentage of patients achieving mycological cure at the day 14 visit was 50.0% (p=0.009) of the patients treated with SB208 4% and 53.1% (p=0.010) of patients treated with SB208 16% versus 23.5% of patients treated with vehicle.
- Mycological cure was maintained at day 42 in both dose groups; 58.8% of patients treated with SB208 16% demonstrated a mycological cure compared to vehicle (p<0.05).
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%, nitric oxide-releasing formulations demonstrated rapid penetration of the nail and effective fungal killing of T. rubrum in 24 hours following a single treatment application.
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