Shaperon announced the enrollment of the first patient in the phase 2 clinical trial for atopic dermatitis treatment candidate Nugel.
The trial will evaluate the efficacy of Nugel in improving the Eczema Area Severity Index (EASI) across a cohort of 210 patients with mild to moderate atopic dermatitis. Employing a double-blind, placebo-controlled methodology, the trial is anticipated to conclude by the first half of 2026.
According to Shaperon, 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," and Shaperon has initiated patent applications for the biomarker.
Nugel, if approved, would be the 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, according to Shaperon. Beyond atopic dermatitis, Nugel holds promise for treating a spectrum of skin conditions.
"Leveraging innovative approaches, such as a smartwatch-based AI medication management system, demonstrates Shaperon's dedication to optimizing patient outcomes and data reliability. The establishment of Hudson Therapeutics, Shaperon's US-based subsidiary, reinforces its strategic vision for global expansion and technology exports," Dr. Seung-Yong Seong, CEO of Shaperon, said in a company news release.
Hudson Therapeutics, a US subsidiary of Shaperon, was founded in 2023 to lead global clinical trials and business development of assets from Shaperon.