Chaperone announced on the 24th via a regulatory filing that its atopic dermatitis treatment candidate 'HY209 gel' failed to meet the primary efficacy endpoint in the top-line results of its Phase 2 clinical trial.

This trial was a randomized, double-blind, placebo-controlled, multi-center Phase 2 clinical study conducted simultaneously in the United States and South Korea. It enrolled a total of 210 patients with mild or moderate atopic dermatitis. The primary endpoint of the trial was the 'percent change from baseline in EASI (Eczema Area and Severity Index) score at 8 weeks of dosing.'

According to the analysis of the ITT (Intention-to-Treat) population, both the high-dose and low-dose HY209 gel treatment groups failed to achieve statistical significance at the pre-specified significance level (two-sided 0.025) compared to the placebo group.

However, the company clarified that these results are based on preliminary top-line primary analysis data provided by the Contract Research Organization (CRO) and represent a stage prior to the preparation of the final Clinical Study Report (CSR). Chaperone plans to conduct additional analysis by September and noted that some details may change depending on future detailed analysis results and regulatory review. Furthermore, this disclosure pertains only to the primary efficacy endpoint results, and detailed results for other indicators such as safety and tolerability will be confirmed through subsequent analysis.

The company intends to carefully review the future development strategy for HY209 gel based on the final analysis results. Additionally, it plans to pursue business diversification by simultaneously adjusting its existing pipeline, including the development of nanobody-based oncology treatments.

Finally, through its investment cautionary notice, Chaperone reminded investors that the statistical probability of a clinical trial drug ultimately receiving regulatory approval as a pharmaceutical product is approximately 10%. The company cautioned investors that outcomes may fall short of expectations during this process, and as a result, the commercialization plan for the novel drug may be altered or discontinued.