Chaperon is showing strong performance. The news that the world's first inflammation complex inhibitor mechanism atopic dermatitis treatment under development has successfully completed the US Food and Drug Administration (FDA) Phase 2b Part 1 clinical trial appears to be influencing the stock price.
As of 9:10 AM on the 14th, Chaperon is trading at 5,100 KRW, up 20.0% from the previous day.
According to FDA regulatory guidelines, the independently operated 'Safety Monitoring Committee (SMC)' reviewed the clinical results of 'Nugel's' Phase 2b Part 1 trial. Chaperon announced that it received a recommendation from the SMC to proceed with the subsequent Phase 2b Part 2 trial.
The Phase 2b Part 1 trial was conducted following FDA recommendations to preliminarily evaluate safety in a multi-ethnic population in the US before the full efficacy trial. Compared to the earlier Phase 2a trial conducted in Korea, the dosage of Nugel was increased up to 8 times in 33 multi-ethnic subjects to confirm more precise drug safety and effective dosage range, and the trial period was doubled to 8 weeks of administration.
In the safety trial evaluating four different doses of Nugel and placebo, drug-related adverse reactions occurred in 0 or 1 subject per test group, while 2 subjects in the placebo group experienced adverse reactions. There was no difference in side effects directly related to the drug compared to the placebo group. Furthermore, no serious drug-related adverse events were observed, confirming safety even with high doses and long-term administration.
In the ‘EASI’ score, which evaluates the efficacy of atopic drugs, Nugel showed superior efficacy compared to currently marketed competing drugs. At a specific dose, 100% of patients met the statistically significant ‘EASI 50’ evaluation criterion (44% in the placebo group, a 56% difference compared to placebo). Although the number of patients was small, this is a positive result regarding the drug’s effect. Compared to competing drugs approved by the FDA for mild to moderate atopic patients in the current market (which show a 15?40% difference in the ‘EASI 50’ evaluation criterion compared to placebo), Nugel’s effect can be considered superior.
Based on the SMC’s recommendation, Chaperon will conduct the Part 2 clinical trial with a total of 12 hospitals, adding 4 hospitals each in the US and Korea to the existing 4 sites, targeting 177 patients of various ethnicities.
A Chaperon representative stated, "Currently, the competing drug considered to have the best efficacy is marketed with a black box warning printed on the packaging due to potential cancer risk side effects. Nugel, with its differentiated inflammation complex inhibitor mechanism, shows excellent efficacy and no side effects even with long-term administration, so if commercialized, it is expected to secure a competitive advantage in the global market."
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