Novan: First Patient Dosed in Phase 2 Anti-Fungal Program

The first patient has been dosed in Novan's clinical program to evaluate the efficacy and safety of topical nitric oxide product candidate SB208 in the treatment of infections caused by dermatophytes such as Trichophyton rubrum (“T. rubrum”). Novan is developing SB208 as a broad-spectrum anti-fungal gel for the treatment of infections of the skin and nails, including athlete’s foot and onychomycosis.

“Initiating our Phase 2 program for SB208 represents another important milestone for Novan in the development of our nitric oxide platform,” said Nathan Stasko, PhD, President and Chief Executive Officer of Novan. “It also represents our next example of taking a fundamental nitric oxide mechanism of action, generating compelling preclinical evidence and then translating that success into a clinical-stage product candidate. In view of the FDA’s recently repeated warning about the use of oral ketoconazole to treat skin and nail fungal infections,¹ 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 key pathogens like T. rubrum in athlete’s foot before broadening the program to assess treatment of other fungal infections.”

This Phase 2 clinical trial is a multi-center, double-blind, randomized, vehicle-controlled, dose-ranging study to determine the dose of SB208 that achieves maximum anti-fungal activity with a favorable safety and tolerability profile. Approximately 170 patients with athlete’s foot will be randomized to either SB208 Gel (2%, 4% or 16%) or vehicle and treated once daily for two weeks. Endpoints at week two and following a four-week post-treatment observation include assessments of mycological, clinical and overall therapeutic cure, which includes both mycological and clinical cure. Novan expects to report top-line results of this Phase 2 trial in the first half of 2017.

In June at ASM Microbe 2016, Novan presented data from preclinical studies demonstrating anti-fungal activity of the Company’s nitric oxide-releasing candidates against T. rubrum. In vitro studies included evaluation of anti-fungal activity utilizing the ChubTur® infected human nail assay, a model utilized previously in the drug development of Kerydin® (tavaborole) Topical Solution, 5%,² and Jublia® (efinaconazole) Topical Solution, 10%.³ In this assay, T. rubrum was inoculated to the underside of human nails and allowed to establish infection. Several of Novan’s nitric oxide-releasing formulations were applied topically to the top of the infected nail plates to assess nail penetration and anti-fungal activity. All of the tested formulations demonstrated effective fungal killing on the underside of the nail in 24 hours following a single treatment application. The poster presentation describing this work is available on the Company’s website at www.Novan.com.