Novan reports positive top-line data from Phase II clinical trial of SB206 against HPV
US-based pharmaceutical company Novan has reported positive top-line results from its Phase II clinical trial of SB206 to treat genital warts caused by human papillomavirus (HPV).
SB206 is a topical anti-viral gel being developed to treat viral skin infections such as external genital and perianal warts caused by HPV.
The Phase II randomised, double-blind, vehicle-controlled clinical trial was held to evaluate the safety and efficacy of the dose and dosing frequency of SB206 while examining 107 patients with external genital warts and perianal warts.
The study was divided into four independent cohorts, in which patients were randomised in a 3:1 ratio to receive SB206 or vehicle for 12 weeks.
Results suggested complete clearance of warts in patients after being administered with SB206, while demonstrating its cutaneous tolerability that was recorded using scores on a four-point grading scale for erythema, edema, erosions or ulcers and burning or stinging.
Novan president and CEO Nathan Stasko said: “The magnitude of effect with favourable tolerability provides us great enthusiasm for patients suffering from the most common sexually transmitted infection in the US.
“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 II 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.”
Novan chief medical officer Dr M Joyce Rico stated that the company is expecting the functionality of the nitric oxide-releasing technology against a range of HPV strains, as well as high-risk subtypes associated with cancers of the head, neck and cervix.