Shaperon said Monday that it has submitted an investigational new drug (IND) application for a U.S. phase 2 clinical trial of its atopic dermatitis drug candidate NuGel to the U.S. Food and Drug Administration.

The multinational phase 2 study will evaluate the drug’s pharmacokinetics, safety, tolerability, and efficacy in 210 patients with mild to moderate atopic dermatitis. Patients will be treated with a placebo and NuGel for about eight weeks in a double-blind test.

Through this trial, Shaperon aims to determine whether NuGel improves the eczema area and severity index (EASI score) compared to placebo in atopic dermatitis patients.

NuGel inhibits inflammatory complexes on immune and vascular cells to reduce the expression of cytokines that exacerbate atopic dermatitis symptoms and increases the number of inflammation-regulating cells in the body, controlling a broad range of inflammatory pathological mechanisms.

"Eighty percent of atopic dermatitis patients are treated with moisturizers and steroids. However, they do not provide a cure and are associated with side effects such as steroid resistance and telangiectasia,” a Shaperon official said. “NuGel shows similar effects to steroids and has also secured safety."