Shaperon, a Korean biotech company, said Thursday that it has completed enrollment of the first patient in its U.S. phase 2 clinical trial of NuGel for treating atopic dermatitis.

Shaperon’s signboard
Shaperon’s signboard

The trial is designed to evaluate NuGel in 210 patients of various ethnicities with mild to moderate atopic dermatitis for improvement in the eczema area and severity index (EASI score). It will be double-blind and placebo-controlled and is expected to end in the first half of 2026.

In September last year, Shaperon received the U.S. Food and Drug Administration (FDA) approval for NuGel's global phase 2 investigative new drug (IND) application.

NuGel is an inflammation-modulating drug for treating atopic dermatitis based on GPCR19 action.

According to Shaperon, NuGel is specific to immune-related cells, has fewer side effects, inhibits both the initiation and amplification phases of key inflammatory complexes, and increases the number of inflammation-suppressing cells in the skin, showing therapeutic effects in skin diseases other than atopic dermatitis.

"We are excited to begin global clinical trials in earnest with the first patient enrollment in the U.S. phase 2 in addition to the clinical trial in Korea," Shaperon CEO Seong Seung-yong said. "We will continue to build on the U.S. phase 2 and our subsidiary Hudson Therapeutics to drive NuGel's global market entry and global technology transfer."

Copyright © KBR Unauthorized reproduction, redistribution prohibited