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Clinical Trials

Novan’s topical anti-fungal treatment SB208 succeeds in phase 2 trial

PBR Staff Writer Published 13 April 2017

A phase 2 trial has revealed that Novan’s topical and silicone based-gel, SB208, demonstrated a significant effect in the treatment of infections caused by dermatophytes such as Trichophyton rubrum (T. rubrum).

The company is developing SB208 as a broad-spectrum antifungal gel to treat superficial cutaneous fungal infections of the skin and nails such as tinea pedis and onychomycosis.

Onychomycosis is a chronic fungal infection of the nails, which is expected to affect around 40 million people in the US.

According to the company, the SB208 Gel, at both the 4% and 16% concentrations, showed a statistically significant effect against vehicle in a clinical trial in patients with tinea pedis or athlete’s foot.

Novan has assessed the tolerability, safety and antifungal activity of SB208 in 222 patients with clinical signs and symptoms of tinea pedis in a double-blind, randomized, vehicle-controlled and dose-ranging clinical trial.

The trail’s primary endpoint was the proportion of patients in each treatment group achieving negative fungal culture at day 14, said the company.

Based on the data of SB208 phase 2 dose-ranging trial, the firm is planning to assess late stage development opportunities in superficial cutaneous fungal infections, including patients with onychomycosis.

Novan intends to start the trial in the second half of this year.

Novan president and CEO Dr Nathan Stasko said: “The results from this Phase 2 trial with SB208 confirm the fungicidal activity of nitric oxide observed in our preclinical studies.

“We have now seen clinical evidence of antibacterial, antiviral and antifungal activity with product candidates from our nitric oxide platform.”


Image: Novan’s topical and silicone based-gel SB208 has showed positive effect to treat superficial cutaneous fungal infections in a phase 2 trial. Photo: courtesy of jk1991 / FreeDigitalPhotos.net.