HPV - Genital Warts
Human papillomavirus (HPV) affects nearly 80 million Americans, and an estimated 14 million new cases of the virus are reported each year, according to the Centers for Disease Control and Prevention, or CDC. There are over 100 subtypes of the virus, characterized as low-risk or high-risk based on their cancer-causing potential. Genital warts are among the world’s most common sexually transmitted diseases. Current treatment options for genital warts consist of ablative procedures that cut, burn or freeze the warts but do not address the underlying viral infection, and there are no currently approved oral or topical prescription products indicated for the treatment of genital warts with a direct anti-viral mechanism of action.
SB206 is first-in-class, topical anti-viral gel in clinical development for the treatment of viral skin infections such as external genital and perianal warts caused by HPV. Novan recently announced statistically significant results from a Phase 2 dose-ranging clinical trial and plans to conduct an End-of-Phase 2 meeting with the FDA in the first half of 2017.
Clinical Trial Results
- 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
- Once-daily treatment arms generally well tolerated, including the most effective dose, 12% once-daily
- Dose responsive pharmacologic effect of SB206 with complete inhibition of papilloma growth in vivo
- Dose-dependent inhibition of HPV-18 viral replication in vitro