Chaperon announced on the 5th that it held a kickoff meeting in the United States for the Phase 2b Part 2 clinical trial of Nugel, an atopic dermatitis treatment.
This clinical trial will be conducted at a total of 12 sites in the United States and Korea, targeting 177 patients of various ethnicities. The goal is to verify the safety and efficacy of Nugel. Chaperon plans to start patient recruitment in March, complete dosing by December this year, and secure the final report by the first half of next year.
Nugel is a next-generation atopic dermatitis treatment developed by Chaperon. It is the world's first new drug with an inflammation complex inhibition mechanism. In this Phase 2b Part 2 trial, two doses of 1% and 2%, which showed safety and excellent efficacy in the previous Part 1, will be tested on a large number of patients to verify Nugel’s safety and efficacy.
After applying to the U.S. Food and Drug Administration (FDA) for clinical trial approval in January this year, Chaperon visited major clinical institutions in the U.S., such as Cahaba Dermatology Skin Health Center and L.A. Universal Research Center, to discuss the progress of the Part 2 trial. In addition, consultations with a total of eight clinical sites in the U.S. have been completed, finalizing preparations for the clinical trial.
On the 28th of last month, a clinical kickoff meeting was held with principal investigators to share the overall clinical trial plan and finalize the clinical protocol and procedures. In Korea, clinical trials are scheduled to be conducted from March at Seoul National University Hospital, Bundang Seoul National University Hospital, Sinchon Severance Hospital, and Sejong Chungnam National University Hospital.
In the previously conducted Phase 2b Part 1 trial, four doses of 0.5%, 1%, 2%, and 4%, along with a placebo, were administered to evaluate safety. As a result, drug-related adverse reactions occurred at a level of 0 to 1 person per test group. Two cases appeared in the placebo group, confirming that side effects directly related to the drug showed no difference compared to the placebo group. No serious drug-related adverse events were reported, demonstrating high safety that differentiates it from competing drugs.
Positive results were also derived in terms of efficacy. In the ‘EASI’ score, which evaluates the effect of atopic dermatitis treatments, Nugel showed superior efficacy compared to currently marketed competing drugs. 100% of patients who received a specific dose met the ‘EASI50 evaluation index’ (a 56% improvement compared to the placebo group), and in the ‘IGA success index (IGA-TS),’ essential for FDA approval, a specific dose group showed more than 39% clinical remission compared to placebo, demonstrating equal or superior effects to previously approved treatments.
A Chaperon official stated, “Since the safety and superior efficacy of Nugel compared to existing treatments were confirmed through the Part 1 trial conducted in the U.S., we expect positive results from this Part 2 trial as well,” adding, “Through this large-scale global Phase 2 trial, we aim to secure highly reliable data while actively pursuing technology transfers with global pharmaceutical companies.”
He continued, “Even the most effective competing drugs have difficulty with long-term administration due to concerns about side effects, whereas Nugel, with the world’s first inflammation complex inhibition mechanism, has excellent safety even with long-term use,” adding, “As the safety and efficacy of Nugel are being proven through clinical trials, global pharmaceutical companies continue to show strong interest.”
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