Novan begins phase 2 study of anti-fungal gel for athlete's foot

Novan announced that is has begun dosing in its phase 2 clinical program to measure efficacy and safety of its topical nitric oxide product candidate SB208 in treating infections caused by dermatophytyes such as Trichophyton rubrum in patients with athlete’s foot.

SB208 is being developed as a broad-spectrum, anti-fungal gel for treating infections of the skin and nails, including athlete’s foot and onychomycosis, according to a press release.

“Initiating our phase 2 program for SB208 represents another important milestone for Novan in the development of our nitric acid platform,” Nathan Stasko, PhD, president and CEO of Novan, stated in the release. “In view of the FDA’s recently repeated warning about the use of oral ketoconazole to treat skin and fungal infections, we believe that physicians and their patients deserve a new fungicidal therapy with an attractive safety profile.

“This study aims to demonstrate activity of topical SB208 against pathogens like [Tricophyton rubrum] in athlete’s foot before broadening the program to assess treatment of other fungal infections.”

In the multi-center, double-blind trial, approximately 170 patients with athlete’s foot will be randomized to treatment of SB 208 (2%, 4% or 16%) or vehicle, with treatment once daily for two weeks. The study is to determine the dose of SB208 that achieves maximum anti-fungal activity and a favorable safety and tolerability profile, according to the release.

Assessments of mycological, clinical and overall therapeutic cure are endpoints at week 2 and following a 4-week post-treatment observation, according to the release.

Top-line results of the trial are expected to be reported in the first half of 2017, according to the release.

Reference: www.novan.com