Phase 2 Trial for Atopic Dermatitis Treatment 'Nugel' Begins

Shaperon, a biotech firm, has initiated a Phase 2 clinical trial for Nugel, a potential treatment for Atopic Dermatitis. The trial, which began with the first patient's enrollment, is a significant step in the company's pursuit to enhance global patient care.

After obtaining FDA clearance for the Global Phase 2 Clinical Trials in September 2023, Shaperon is now focused on assessing Nugel's effectiveness in enhancing the Eczema Area Severity Index (EASI) for a group of 210 individuals with mild to moderate Atopic Dermatitis. The trial, set to conclude by mid-2026, employs a double-blind, placebo-controlled approach to ensure scientific rigor.

The global Atopic Dermatitis market is predicted to grow robustly, with a forecasted increase of over 8.7%, reaching a valuation of $19.1 billion by 2030. Present treatments include steroids and FDA-approved drugs, but there is an evident demand for new medications due to their side effects and limited effectiveness.

Shaperon's Phase 2 clinical trials in Korea revealed a biomarker that elicited positive responses in more than 70% of the patients, termed "A type A atopic patients." This biomarker is now being patented, with the aim of providing personalized treatments for those who respond exceptionally well to Nugel.

Nugel is a groundbreaking drug for Atopic Dermatitis, being the first to target 'GPCR19' action for inflammation control. Its unique mechanism targets immune-related cells, resulting in minimal side effects while effectively managing inflammatory pathways. The drug's potential extends beyond Atopic Dermatitis, indicating its possible broader impact on global healthcare.

Dr. Seung-Yong Seong, CEO of Shaperon, emphasized the company's dedication to expanding Nugel's global reach and facilitating technology transfer through the Phase 2 trials. Innovative strategies, such as a smartwatch-based AI medication management system, are being utilized to enhance patient outcomes and ensure data reliability. The establishment of Hudson Therapeutics, Shaperon's U.S. subsidiary, demonstrates the company's strategic vision for global expansion and technology exports.

Shaperon is in the clinical stage of development, focusing on novel inflammasome inhibitors. Its GPCR19-P2X7 modulation mechanism suppresses a wide range of inflammatory cytokines, addressing both the priming and activation phases of the inflammasome. This innovative approach is particularly suited for complex immune-mediated inflammatory disorders, with Shaperon currently developing clinical programs for various conditions, including Atopic Dermatitis, cytokine release syndrome, Alzheimer’s disease, Obesity, and MASH.

Hudson Therapeutics, Shaperon's U.S.-based subsidiary, was established in 2023 to lead global clinical trials and business development. Its pipeline includes immunology clinical assets for Atopic Dermatitis, Covid-19, Alzheimer’s Disease, and preclinical programs for Obesity and other indications, alongside a nanobody platform.