Shaperon Inc. announced the enrollment of the first patient in the Phase 2 clinical trial for Nugel, its therapy for Atopic Dermatitis. This milestone marks the start of a crucial phase in Shaperon's effort to advance treatment for patients globally. With FDA approval secured for the Global Phase 2 Clinical Trials (IND) of Nugel in September 2023, Shaperon is dedicated to evaluating its efficacy in improving the Eczema Area Severity Index (EASI) across a diverse cohort of 210 patients with mild to moderate atopic dermatitis.

Employing a rigorous double-blind, placebo-controlled methodology, the trial is anticipated to conclude by the first half of 2026. Market research forecasts indicate a robust growth of over 8.7%, projecting the global atopic dermatitis market to reach $19.1 billion by 2030. Presently, patients rely on steroids and FDA-approved medications, yet there remains a pressing need for novel drugs due to their adverse effects and limited efficacy.

Of particular note, more than 70% of patients exhibit positive responses to the biomarker discovered during Shaperon's phase 2 clinical trials in Korea, categorized as "A type A atopic patients." This treatment, distinguished by its superior safety and efficacy compared to existing JAK inhibitors or PDE4 inhibitors in the market, has garnered attention at U.S. and European forums. Shaperon has already initiated patent applications for this biomarker, enabling tailored treatments for patients showing exceptional responses to Nugel. Nugel represents a paradigm shift in atopic dermatitis therapy as the world's first inflammation control drug targeting 'GPCR19' action. Its unique mechanism of action, exclusive to immune-related cells, offers minimal side effects while effectively addressing inflammatory pathways.

Beyond atopic dermatitis, Nugel holds promise for treating a spectrum of skin conditions, further underscoring its potential impact on global healthcare.