Novan Reports Positive Topline Results With SB208 In Phase 2 Trial

(RTTNews) - Novan, Inc. (NOVN), a late-stage pharmaceutical company, announced Wednesday positive topline results from its Phase 2 clinical trial with SB208, a topical, silicone based-gel under development for the treatment of infections caused by dermatophytes such as Trichophyton rubrum, or T. rubrum.

In pre-market activity on Nasdaq, Novan shares were gaining 34.6 percent to $7.

Novan is developing SB208 as a broad-spectrum antifungal gel for the treatment of superficial cutaneous fungal infections of the skin and nails, including tinea pedis and onychomycosis.

The company said its SB208 Gel, at both the 4% and 16% concentrations, demonstrated a statistically significant effect compared to vehicle in a clinical trial in patients with tinea pedis, or athlete's foot. Clinical activity against dermatophytes was measured by incidence of a negative fungal culture after two weeks of treatment.

Onychomycosis is a chronic fungal infection of the nails, and Novan estimates that it affects more than 40 million people in the United States.

Based on the data generated in this SB208 Phase 2 dose-ranging trial, Novan will evaluate late stage development opportunities in superficial cutaneous fungal infections, such as a Phase 2 trial in patients with onychomycosis, to be initiated as early as the second half of 2017.

Nathan Stasko, President and Chief Executive Officer of Novan, said, "We have now seen clinical evidence of antibacterial, antiviral and antifungal activity with product candidates from our nitric oxide platform. Our ability to deploy antimicrobial doses of nitric oxide in this trial gives us confidence to move forward in the development of a potential treatment for hard-to-treat infections like onychomycosis."