Novan announces efficacy of SB206 in treating genital warts

Novan has announced results of its phase 2 clinical trial of SB206 for treating genital warts caused by human papillomavirus.

There was a significant improvement (P < .05) in the incidence of complete clearance in all baseline warts when treated with SB206 12%, the highest dose tested, when compared to vehicle treatment at 12 weeks in both intent-to-treat and per-protocol analyses, according to a press release.

“SB206 represents another drug candidate from our platform that has now shown the repeatability of taking fundamental nitric oxide mechanism of action, generating compelling preclinical evidence and then translating that success into statistically significant results in phase 2 clinical trials,” Nathan Stasko, PhD, president and CEO of Novan, stated in the release. “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.”

There were 107 patients aged 18 to 50 years with external genital warts and perianal warts studied in the randomized, double-blind trial, according to the release. Patients were randomized to receive SB206 or vehicle, with treatment of 12 weeks. Doses of SB206 included 4% twice daily, 4% once daily, 8% once daily and 12% once daily.

Complete clearance of all warts by week 12 was achieved by 33% of patients in the SB206 12% once-daily treatment cohort, compared with 4% of patients achieving complete clearance with vehicle once daily (P = .0099) when using intent-to-treat analysis. Per-protocol analysis for patients who completed 12 weeks of dosing found that 42% of patients in the SB206 12% once-daily dosing cohort achieved complete clearance of all warts, compared with 7% in the vehicle cohort (P = .0200).

The SB206 treatments were generally well-tolerated, with treatment-emergent adverse events including application site reactions, according to the release.

Novan reports it expects to discuss the SB206 development program with the FDA in the first half of 2017.

Reference: www.novan.com