SB208 antifungal gel demonstrates significant effect in treating tinea pedis

Novan announced positive results from its phase 2 clinical trial showing that SB208 gel, at both the 4% and 16% concentrations, demonstrated a statistically significant effect compared to vehicle in patients with tinea pedis.

SB208, a topical, silicone based-gel is under development for the treatment of infections caused by dermatophytes such as Trichophyton rubrum. SB208 is a broad-spectrum antifungal gel for treating superficial cutaneous fungal infections of the skin and nails, including tinea pedis and onychomycosis, according to a press release.

“The results from this phase 2 trial with SB208 confirm the fungicidal activity of nitric oxide observed in our preclinical studies,” Nathan Stasko, PhD, president and CEO of Novan, stated in the release. “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.”

In the double-blind trial, SB208 was evaluated in 222 patients with tinea pedis, who were randomly assigned to one of three active or vehicle treatment arms, applying either SB208 Gel (2%, 4% or 16%) or vehicle once-daily for 2 weeks, followed by a 4-week posttreatment observation period.

Primary endpoint was the proportion of patients in each treatment group achieving negative fungal culture at day 14.

In the primary efficacy analysis of patients, 80.6% (P = 0.002) of patients treated with SB208 4% and 74.2% (P = 0.016) of patients treated with SB208 16% achieved negative fungal culture at day 14 vs. 45.5% of patients treated with vehicle, according to the release. Per-protocol analysis found similar results: SB208 4% and 16% demonstrated statistical superiority to vehicle-treated subjects (P < 0.05).

“Fungal infections of the skin and nails are persistent, in part because there are no currently-approved therapies that treat both with a single topical product,” Leon Kircik, MD, associate clinical professor of dermatology at Indiana University Medical Center in Indianapolis and Icahn School of Medicine at Mount Sinai Medical Center in New York and medical director of DermResearch PLLC and Physicians Skin Care PLLC. stated in the release. “These clinical trial results in patients with tinea pedis, paired with the previously released preclinical rapid nail penetration data, suggest that Novan’s SB208 may provide an effective topical alternative to simultaneously treat the nail plate, the interdigital space and the surrounding cutaneous tissue, thereby potentially improving initial efficacy while decreasing relapse or reinfection.”

Based on data from the trial, Novan reports it will evaluate late stage development opportunities in superficial cutaneous fungal infections, such as a phase 2 trial in patients with onychomycosis, starting as early as second half of 2017.

Reference: www.novan.com