Number of Patients with Complete Clearance of Genital Warts Provides Clinical Evidence of Nitric Oxide Anti-Viral Activity Against HPVCompany Plans End-of-Phase 2 Meeting for First Half of 2017 MORRISVILLE, N.C., Nov. 29, 2016 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced top-line results from the Company's Phase 2 clinical trial with SB206 for the treatment of genital warts caused by human papillomavirus, or HPV. The highest dose tested, SB206 12%, demonstrated a statistically significant improvement (p<0.05) in the incidence of complete clearance of all baseline warts compared to vehicle treatment after 12 weeks in both the intent-to-treat and per-protocol analyses. "These data are impressive. The magnitude of effect with favorable tolerability provides us great enthusiasm for patients suffering from the most common sexually transmitted infection in the United States," said Nathan Stasko, PhD, President and Chief Executive Officer of Novan. "Importantly, SB206 represents another drug candidate from our platform that has now shown the repeatability of taking a fundamental nitric oxide mechanism of action, generating compelling preclinical evidence and then translating that success into statistically significant results in Phase 2 clinical trials. Genital warts was our first viral target, and as we develop SB206 further we intend to diligently investigate the numerous other viral skin infections in need of new treatment options." In this randomized, double-blind, vehicle-controlled clinical trial, the safety and efficacy of SB206 was evaluated in 107 patients with external genital warts and perianal warts. The dose and dosing frequency of SB206 was tested in four independent cohorts in which patients were randomized in a 3:1 ratio to either SB206 or vehicle and treated for up to 12 weeks. SB206 doses included SB206 4% twice-daily, 4% once-daily, 8% once-daily and the highest dose evaluated, 12% once-daily. Patients eligible for this clinical trial were males or females, 18 to 50 years of age, with 2 to 20 warts on the genital or perianal area. The mean wart count burden per patient at baseline was 7.4 warts.