Novan CEO Discusses Its HPV Drug And Clinical Trial Results

Novan Inc NOVN is a small-cap late-stage pharmaceutical company focused on the treatment of acne vulgaris, external genital and perianal warts, fungal infections of the skin and nails, and inflammatory skin diseases. The stock has gained almost 58 percent since its late-September IPO, driven by encouraging clinical trial results and positive analyst ratings.

Benzinga recently had the chance to chat with the company’s CEO Nathan Stasko, Ph.D., who shared some insight into recent data, the HPV market, capital needs and institutional backing, among several other subjects.

HPV Data

Benzinga first asked about the results of the Phase 2 clinical trial with SB206 for the treatment of genital warts caused by human papillomavirus (HPV), which has been estimated to affect 79 million people in the United States, reaching 14 million new patients ever year.

“SB206 is a topical gel that is designed to release nitric oxide when you apply it to the surface of the skin. It releases nitric oxide in enough quantity to be directly antiviral to the human papilloma virus target,” Stasko explained. “That whole program built on in vitro success, showing we could target HPV in human skin cells, and then in vivo success with the target HPV infections and actually prevent large papillomas or large warts from growing in animal models.

“Now, the phase 2 success demonstrates our ability to show that nitric oxide translates that entire continuum and now demonstrates a clinical benefit by completely clearing genital warts in the clinical trials. So the endpoint for the clinical trial in phase 2 was the complete clearance of baseline warts.”

“I think that level of efficacy, the complete clearance, clearly demonstrates nitric oxide’s antiviral potential against HPV,” he continued. “I think –broadly- the significance of being the first really topical antiviral against the papilloma virus unlocks a number of skin infections caused by viruses like other common warts and then some of the high risk diseases also caused by HPV.”

As stated above, HPV reaches millions of people in the United States alone. So, what’s the size of the market?

“Certainly, from an epidemiology and a public health perspective, it is huge in carriers, and huge in people that it could possibly affect,” the chief executive explicated.

What Makes SB206 Special?

Stasko moved on to expound why SB206 is special. “[T]his is really the first drug that has a direct antiviral mechanism against HPV [...] The adverse effects for other topicals are— huge [...] So, when we were developing our product, SB206, we had very tight criteria on, if you had any of those ulcers or erosions [caused by other topicals] we were going to stop and discontinue that [our] dose because the marketplace doesn’t need another poorly tolerated solution.”

“So, tolerability and safety was a fundamental tenet of our entire nitric oxide program,” he supplemented.

At last check, shares of Novan were down 0.32 percent at $28.35.