Novan announced Phase II efficacy and safety data for SB208, a topical, silicone-based gel under development for the treatment of fungal infections of the skin and nails. In a Phase II double-blinded, randomized, vehicle-controlled, dose-ranging clinical trial, the tolerability, safety and antifungal activity of SB208 was evaluated in 222 patients with clinical signs and symptoms of tinea pedis, or Athlete’s Foot. Patients were randomized evenly to one of three active or vehicle treatment arms, applying either SB208 Gel (2%, 4% or 16%) or vehicle once-daily for two weeks, followed by a four-week post-treatment observation period. In the primary efficacy analysis of subjects with evaluable culture results, 61.3% (p=0.209) of patients treated with SB208 2%, 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 34.4% (p=0.305) of the patients treated with SB204 2%, 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. At day 42, the highest mycological cure rates were observed in 58.8% of patients treated with SB208 16% (p=0.020 compared to vehicle). The percentage of patients achieving clinical cure at day 42 was 14.3% of the patients treated with SB208 2%, 29.7% of the patients treated with SB208 4% and 25.0% of patients treated with SB208 16% versus 14.3% of patients treated with vehicle. The overall incidence of adverse events was low (nine subjects or 4%) and similar in all groups. None of the treatment emergent adverse events were determined to be related to the study medication, and no patients discontinued treatment or dropped out of the study due to an adverse event. Based on the positive data generated in this SB208 Phase II dose-ranging trial, Novan intends to evaluate potential partnerships to advance the antifungal candidate into later stages of development.