Chaperon: "US FDA Phase 2 Clinical Trial Confirms Safety... Next-Generation Atopic Dermatitis Treatment Draws Global Big Pharma Interest"

Chaperon, a bio company specializing in immune innovation drug development, announced on the 3rd that its next-generation atopic dermatitis treatment has been proven safe in the Phase 2 clinical trial by the U.S. Food and Drug Administration (FDA).

Chaperon stated on the 3rd that it received a recommendation from the FDA’s Safety Monitoring Committee (SMC) to continue dose escalation and clinical trials of its atopic dermatitis treatment, Nugel. This is expected to give further momentum to Nugel’s Phase 2 clinical trial.

Following the first SMC’s recommendation to continue the trial in May this year, safety was confirmed in the secondary data collected from the high-dose treatment group and placebo group patients. Based on the decision of the second SMC, Chaperon plans to complete the dosing trial for the last cohort of clinical patients at a higher dose by November.

Chaperon is conducting an FDA Phase 2 clinical trial to determine the optimal therapeutic dose of Nugel in 210 patients with mild to moderate atopic dermatitis of various ethnicities in the U.S. Specifically, the Phase 2 trial is divided into two parts: dose escalation and fixed-dose administration, using randomized allocation, double-blind, placebo-controlled methods to evaluate efficacy and safety, including the Eczema Area and Severity Index (EASI) score.

Nugel is the world’s first atopic dermatitis treatment that acts on ‘GPCR19’ of immune cells and epithelial cells, inhibiting the inflammatory complex. Unlike existing inflammatory complex inhibitors that suppress the activation stage of inflammation, Nugel acts doubly at both the initiation and amplification stages of inflammation, enabling effective inflammation control.

Nugel effectively blocks the inflammatory response caused by T lymphocytes to treat atopic dermatitis. It is designed with a selective T lymphocyte inhibition mechanism to minimize effects on other immune systems beyond inflammation suppression. While existing competitor drugs simultaneously inhibit all T lymphocyte functions in atopic patients, leading to excessive immune suppression, increased cancer incidence, and side effects such as opportunistic infections, Nugel has no such immunosuppressive side effects, giving it strong global competitiveness, according to the company.

A Chaperon representative said, “Nugel demonstrated safety and efficacy in 80% of the biomarker-positive patient group at a 0.5% dose in the domestic Phase 2a clinical trial last year. The recent SMC decision confirmed safety at a 2% high dose, which is four times higher than the domestic trial dose and was obtained from a diverse ethnic patient group, making it a very encouraging result.”

He added, “By November this year, we plan to administer up to a 4% dose in clinical trials and determine the optimal therapeutic dose based on the results of each dose. Starting next year, we will conduct follow-up trials administering the confirmed dose to patients of various ethnicities to study dose-response relationships, drug safety, and correlations with biomarkers, aiming to complete Phase 2 clinical trials by the first half of 2026.”

According to industry sources, the global atopic dermatitis treatment market was estimated at $16.9 billion (approximately 23 trillion KRW) last year and is expected to exceed $40.8 billion (approximately 55 trillion KRW) by 2032. Despite market growth, atopic dermatitis patients demand new drugs due to side effects and insufficient efficacy, making it a field of interest for global big pharma companies. The company explained that Nugel will actively target the pediatric atopic dermatitis market as well, as it is superior to competing drugs not only in efficacy but also in safety.