Proven local safety and minimal systemic exposure
[by Yu, Suin] Shaperon announced on May 15 that the Phase 1 clinical trial results evaluating the safety of ‘NuGel,’ a next-generation atopic dermatitis treatment candidate specifically targeting Korean patients, were recently published in ‘Clinical and Translational Science (CTS),’ the official academic journal of the American Society for Clinical Pharmacology and Therapeutics.
CTS is an authoritative journal in the fields of 바카라사이트 소울카지노 pharmacology and translational science, attracting significant attention from global pharmaceutical companies. This publication of this study indicates that the scientific basis for the safety profile of NuGel, which sets it apart from competing drugs, has received international recognition, potentially accelerating its path to commercialization in the future.
The paper provides scientific evidence for the local safety of NuGel and its inherent ability to minimize systemic exposure, based on a Phase 1 바카라사이트 소울카지노 trial involving 56 healthy adult participants. The study employed a single ascending dose (SAD) and a 28-day multiple ascending dose (MAD) design, evaluating a range of concentrations. The results demonstrated a favorable safety profile, with no significant adverse reactions observed in any dose group, including the highest concentration. Furthermore, the trial confirmed minimal changes in blood drug levels, greatly reducing concerns regarding systemic absorption and associated side effects.
바카라사이트 소울카지노 is the world's first 'topical drug' specifically targeting GPCR19 receptors expressed in innate immune cells and skin cells. Traditional approaches to treating skin inflammation have primarily focused on suppressing T lymphocyte activity. However, this broad immunosuppression can reduce the ability to eliminate cancer cells, potentially increasing cancer risk. In fact, several competing treatments have received marketing approval with the requirement to include cancer risk warnings on their packaging, leading to hesitancy among pediatric and certain adult patients, according to Shaperon.
In contrast, another competing drug targets enzymes in epithelial cells and innate immune cells, but its 바카라사이트 소울카지노 efficacy has been limited. A company developing a first-generation drug based on this mechanism was acquired by Pfizer for KRW 6 trillion (approximately USD 4.2 billion) during its phase 3 바카라사이트 소울카지노 trials, yet it has struggled to achieve meaningful sales due to low efficacy and various side effects. In comparison, NuGel has demonstrated a strong safety profile in domestic phase 2a 바카라사이트 소울카지노 trials and U.S. phase 2b 바카라사이트 소울카지노 trials part 1. The company emphasized that the recent publication of its Phase 1 바카라사이트 소울카지노 trial results, which directly compared NuGel to global competing drugs, is considered a notable achievement in the market.
“The publication of this paper has provided international recognition for the scientific basis supporting the safety of 바카라사이트 소울카지노,” a Shaperon official said. “바카라사이트 소울카지노 is expected to be highly competitive in the global market, as it offers a patient-centered, customizable approach with fewer side effects compared to existing therapies.”
“Based on the results from Part 1 of the Phase 2 바카라사이트 소울카지노 trial in the U.S., NuGel is poised to become the world’s first atopic dermatitis treatment capable of overcoming the critical ‘carcinogenicity’ risks associated with the leading competing drugs, while offering comparable or superior efficacy,” the official further added.
Conversely, Shaperon is currently conducting a Phase 2b 바카라사이트 소울카지노 trial targeting patients with mild to moderate atopic dermatitis from diverse ethnic backgrounds in both Korea and the United States. Part 1 of the trial, focused on dose escalation, was completed in January this year, and patient recruitment for Part 2 is proceeding as planned, with the aim of completion by June 2026. This Phase 2b study will comprehensively assess EASI score improvement, safety, dose response, and biomarker correlations.
Based on the findings from the Phase 2b Part 1 바카라사이트 소울카지노 trial, Shaperon anticipates that NuGel will address the limitations associated with steroid-based therapies and T-lymphocyte suppression treatments, effectively meeting patients’ medical needs and driving increased sales.