Hudson Therapeutics, a U.S. subsidiary of Shaperon, has announced the successful completion of Part 1 of its Phase 2b clinical trial for Nugel, a novel inflammatory complex inhibitor being developed for the treatment of atopic dermatitis. The Safety Monitoring Committee (SMC) has recommended advancing to Part 2 of the trial, marking a significant step toward full-scale efficacy evaluation. The study was conducted under FDA guidance to assess the preliminary safety of Nugel in a multi-ethnic U.S. cohort before proceeding with efficacy testing.
Safety and Tolerability
The Phase 2b Part 1 trial involved increasing Nugel dosages up to eightfold compared to previous trials conducted in South Korea, with the study period extended to eight weeks. The safety evaluation, which tested four different Nugel doses and a placebo, revealed no significant side effects linked to the drug. Adverse events were minimal and comparable to the placebo group, with 0-1 drug-related cases per treatment group versus 2 in the placebo group. These results indicate that Nugel demonstrated exceptional tolerability, even at higher doses and extended durations.
Efficacy Results
In terms of efficacy, Nugel achieved the EASI 50 index, a benchmark for atopic dermatitis treatments. At an optimized dose, 100% of patients reached EASI 50, compared to 44% in the placebo group. Furthermore, Nugel demonstrated comparable or superior performance against FDA-approved competitor drugs for mild to moderate atopic dermatitis. The drug also achieved significant results in IGA-TS metrics, with a clinical response rate surpassing 39% in a specific dose group, matching or exceeding top-performing competitor treatments.
Management Commentary
"Completing Phase 2b Part 1 with such promising safety and efficacy data strengthens our confidence in Nugel's transformative potential. We are excited to proceed to the next clinical development phase and continue our work to bring this groundbreaking treatment to patients globally," said Janice Marie McCourt, CEO of Hudson Therapeutics. Dr. Seung-Yong Seong, CEO of Shaperon, added, "Nugel's ability to deliver exceptional efficacy while maintaining an outstanding safety profile represents a major advancement in the treatment of atopic dermatitis."
Next Steps
With Part 1 successfully completed, Part 2 will involve a larger, diverse cohort of 177 patients across 12 U.S. clinical sites, with four additional sites planned in both the U.S. and South Korea. The expanded trial aims to reinforce Nugel's efficacy and safety profile while advancing toward regulatory approval in the US and South Korea.
About Nugel
Nugel is the world's first inflammatory complex inhibitor for atopic dermatitis. Shaperon's unique GPCR19-P2X7 modulation mechanism suppresses a range of inflammatory cytokines, including IL-1β, IL-18, IL-6, and TNF-α, by targeting both priming and activation phases of the inflammasome.
