Hudson Therapeutics Launches Phase 2b Part 2 Trial for NuGel
Hudson Therapeutics, the U.S. subsidiary of Shaperon, announced today the initiation of Phase 2b Part 2 of its clinical trial for NuGel, a groundbreaking inflammasome inhibitor aimed at treating mild to moderate atopic dermatitis. The trial’s kickoff meeting took place in March in the United States, marking a key milestone in the global clinical development of NuGel.
Hudson Therapeutics, the U.S. subsidiary of Shaperon, has announced the launch of Phase 2b Part 2 of the clinical trial for NuGel, a first-in-class inflammasome inhibitor designed to treat mild to moderate atopic dermatitis. This next phase follows the successful completion of Phase 2b Part 1, and will be conducted across 12 clinical sites in both the U.S. and South Korea, enrolling 177 patients from diverse ethnic backgrounds. The study is expected to further evaluate the safety and efficacy of NuGel, building on promising results from earlier phases. Patient enrollment is set to begin in March 2025, with dosing expected to be completed by December 2025. Final clinical data is anticipated to be available by the first half of 2026.
NuGel, a topical treatment, uses inflammasome inhibition—a novel mechanism designed to reduce inflammation and potentially offer better long-term safety for patients with atopic dermatitis. This new approach addresses a key unmet need in dermatology, as current treatments for the condition often come with limitations in safety, efficacy, or long-term use.
In Phase 2b Part 1, NuGel showed promising results with an excellent safety profile and better efficacy compared to currently marketed treatments. Key findings from this phase include:
- Eczema Area and Severity Index (EASI): NuGel showed better score improvements compared to competitive treatments.
- EASI-50 Response Rate: 100% of patients in a specific NuGel dosage group met the EASI-50 criteria, representing a 56% improvement over the placebo group.
- IGA Treatment Success (IGA-TS): NuGel achieved a 39% higher clinical remission rate compared to the placebo, a key FDA approval benchmark.
“We are excited to initiate Phase 2b Part 2 of NuGel’s clinical trial, building on the promising results from the previous phase,” said Seung-Yong Seong, CEO of Shaperon. “This study will further validate NuGel’s efficacy and long-term safety, reinforcing its potential as a transformative treatment for atopic dermatitis. We are confident that this large-scale global trial will generate valuable clinical trial data, bringing us one step closer to delivering an innovative therapy to patients worldwide.”
In preparation for this trial phase, Shaperon has formed partnerships with leading U.S. clinical research institutions, including Cahaba Dermatology Skin Health Center and L.A. Universal Research Center, as well as eight other clinical trial sites across the U.S. The study will also be conducted in South Korea at prominent research sites, including Seoul National University Hospital, Bundang Seoul National University Hospital, Severance Hospital, and Sejong Chungnam National University Hospital. These partnerships aim to ensure the successful execution of the clinical trial, leveraging expertise and resources from renowned institutions.
As the U.S. subsidiary of Shaperon, Hudson Therapeutics is actively pursuing global pharmaceutical partnerships to explore licensing and commercialization opportunities for NuGel. “Hudson Therapeutics is committed to advancing innovative therapies, and we recognize NuGel’s global potential in the mild to moderate atopic dermatitis market,” said Janice Marie McCourt, CEO of Hudson Therapeutics.
“We have strong interest from numerous specialty pharmaceutical companies and are actively engaged in contracting a top-tier partner to commercialize NuGel. The growing demand for treatments for the approximately thirty-five million patients globally suffering from atopic dermatitis presents a significant market opportunity, and we believe NuGel has the potential to redefine the standard of care. Through global partnerships, we aim to accelerate its path to commercialization and bring this breakthrough therapy to patients worldwide.”
Atopic dermatitis, a common inflammatory skin condition, affects millions of people worldwide, often causing discomfort, pain, and distress. Current treatments, while effective for some, are limited in scope, particularly for those with moderate to severe forms of the condition. NuGel’s unique mechanism targeting inflammasomes provides a new approach to treating the disease, offering hope for better management and improved long-term outcomes.
Shaperon, the parent company of Hudson Therapeutics, is a clinical-stage biotech company focused on developing novel inflammasome inhibitors. The company’s approach, which modulates the GPCR19-P2X7 pathway, suppresses inflammatory cytokines such as IL-1β, IL-18, IL-6, and TNF-α, targeting both the priming and activation phases of the inflammasome. This pioneering mechanism is being explored in various clinical programs, including atopic dermatitis, alopecia areata, Alzheimer’s disease, and COVID-19 pneumonia, as well as in preclinical programs for MASH (Metabolic Associated Steatohepatitis) and obesity.
The Phase 2b Part 2 trial of NuGel represents a significant step forward in Shaperon’s commitment to developing innovative therapies for immune-mediated inflammatory disorders. With promising clinical data, strong partnerships, and an expanding market need for effective treatments for atopic dermatitis, NuGel has the potential to be a game-changer in the dermatology field.
