Top-line results from Novan Inc.’s Phase 2 clinical trial with SB206 for the treatment of  genital warts caused by human papillomavirus, or HPV show statistically significant benefits, the company reports. 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.

The primary endpoint for this clinical trial was the proportion of patients who were completely clear of warts that were present at baseline at or before week 12. In the intent-to-treat analysis, 33% of patients achieved complete clearance of all warts by week 12 when treated with SB206 12% once-daily, compared to only 4% of patients achieving complete clearance with vehicle once-daily (p=0.0099). In the per-protocol analysis containing patients who completed a full 12 weeks of dosing, 42% of patients achieved complete clearance of all warts when treated with SB206 12% once-daily, compared to only 7% of patients achieving complete clearance with vehicle once-daily (p=0.0200).

The cutaneous tolerability of SB206 was carefully monitored and recorded using scores on a four-point grading scale for erythema, edema, erosions or ulcers and burning or stinging. The once-daily treatment arms were generally well tolerated, including the most effective dose, 12% once-daily. The most frequently reported treatment-emergent adverse events were application site reactions, the percentage of which was highest in patients treated with SB206 4% twice-daily. Based on the local application site adverse-event profile and the Company's strict, pre-specified stopping criteria, SB206 4% twice-daily was discontinued, and all of the remaining cohorts were dosed once-daily. 

Based on the data generated in this Phase 2 dose-ranging trial, Novan expects to discuss the entirety of the SB206 development program with the US FDA in the first half of 2017 and, assuming a successful end-of-Phase 2 meeting with the FDA , plans to initiate the Company's late-stage program with Phase 3 pivotal clinical trials of SB206 in the second half of 2017.