Shaperon: "Atopic Dermatitis Treatment Shows Safety in US FDA Phase 2 Clinical Trials"
[Whole News Article in English]
Shaperon (Kosdaq: 378800), a biotech company specializing in innovative immunotherapy drug development, announced on the 3rd that its next-generation atopic dermatitis treatment has been verified for safety in a Phase 2 clinical trial by the US Food and Drug Administration (FDA).
The FDA's Independent Data Monitoring Committee (IDMC) has recommended that Shaperon proceed with the next stage of dosing and continue clinical trials for its atopic dermatitis treatment, Nugel. This marks significant progress for the Phase 2 trial of Nugel.
Following the IDMC’s recommendation to continue the trial in May, safety was confirmed once again in the second set of data collected from both high-dose and placebo groups. Based on this second IDMC decision, Shaperon plans to complete the final cohort dosing trial with a higher dosage by November.
Shaperon is currently conducting a Phase 2 FDA clinical trial for Nugel, targeting 210 patients with mild to moderate atopic dermatitis of various ethnic backgrounds across the US. This trial is designed to determine the optimal therapeutic dose of Nugel, divided into two parts: dose escalation and fixed-dose administration. Efficacy and safety, including metrics such as the Eczema Area and Severity Index (EASI), are being evaluated in a randomized, double-blind, placebo-controlled format.
Nugel is the world’s first atopic dermatitis treatment that inhibits the inflammasome by targeting the ‘GPCR19’ receptors on immune and epithelial cells. While existing inflammasome inhibitors block the activation phase of inflammation, Nugel acts on both the initiation and amplification phases, allowing for more effective inflammation control.
Nugel works by effectively blocking T-cell-mediated inflammatory responses, treating atopic dermatitis. It is specifically designed to inhibit selective T-cells, minimizing effects on other immune systems, which sets it apart from existing competitors. Other treatments suppress the overall function of T-cells, potentially leading to excessive immune suppression, increasing the risk of cancer and infections. In contrast, Nugel avoids such side effects, giving it strong global competitiveness.
A Shaperon representative stated, "Nugel demonstrated safety and efficacy in a 0.5% dose during a Phase 2a clinical trial in Korea, showing positive results in 80% of biomarker-positive patients. The recent IDMC decision confirms safety at a 2% high dose, four times higher than in the Korean trial, and across a diverse range of ethnic groups, which is a highly encouraging outcome."
He added, "By November this year, we plan to complete dosing at a maximum 4% concentration. Based on the results, we will determine the optimal therapeutic dose. From next year, we will administer the confirmed dose to a variety of patients and continue follow-up trials, examining dose-response relationships, drug safety, and correlations with biomarkers. Our goal is to complete the Phase 2 clinical trial by the first half of 2026."