Novan reports positive top-line results in mid-stage study of antifungal drug SB208; shares climb

Shares in Novan surged as much as 65 percent Wednesday after the drugmaker unveiled positive top-line results in a Phase II study of the experimental superficial cutaneous fungal infection treatment SB208. Study data showed that the therapy produced a statistically significant effect in patients with tinea pedis versus vehicle. Novan CEO Nathan Stasko said "the results from this Phase II trial with SB208 confirm the fungicidal activity of nitric oxide observed in our preclinical studies." 

In the mid-stage trial, the safety, tolerability and antifungal activity of SB208 was examined in 222 patients with clinical signs and symptoms of tinea pedis. Patients were randomised to treatment with 2 percent, 4 percent or 16 percent SB208 gel or vehicle once daily for two weeks followed by a four-week observation period. The primary endpoint of the study was the proportion of patients with a negative fungal culture at day 14, while secondary endpoints included mycological cure, defined as both a negative fungal culture and negative skin scraping for the presence of fungus, at day 14 and day 42. 

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Findings from the study in the primary efficacy analysis of patients with evaluable culture results illustrated that 80.6 percent of patients treated with 4 percent SB208 and 74.2 percent of those treated with 16 percent exhibited negative fungal cultures at day 14, compared to 45.5 percent of patients in the vehicle arm. In addition, 50 percent of patients in the 4 percent SB208 group and 53.1 percent of patients in the 16 percent SB208 group achieved mycological cure at day 14, versus 23.5 percent of vehicle-treated subjects, while the effect was maintained in both dose groups at day 42. 

Based on the study results, Novan said that it plans to assess late-stage development opportunities for SB208 in superficial cutaneous fungal infections, including a Phase II study in patients with onychomycosis slated to begin as early as the second half of this year. 

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