[E-Daily Reporter Shin Ha-yeon ] Shaperon Inc.(378800)announced on the 10th that it had received analysis results from an external statistical analysis firm regarding the IGA-TS (Investigator’s Global Assessment-Target Sign), the secondary endpoint of the global Phase 2b clinical trial for “NuGel,” a treatment for atopic dermatitis.

According to the company, NuGel showed a 13.8% difference in IGA-TS (p=0.053) compared to the placebo as of Week 4 of treatment in Part 2 of the global Phase 2b clinical trial. In the previously conducted Part 1, it had shown a difference of 22–39% compared to the placebo.

IGA-TS is a metric used by healthcare professionals to assess the condition of a patient’s skin lesions; it is also a standard utilized as a primary endpoint in Phase 3 clinical trials for atopic dermatitis treatments under U.S. Food and Drug Administration (FDA) guidelines.

Although Shaperon Inc. noted that the Part 2 results appeared somewhat diluted compared to Part 1, the company emphasizes the significance of the fact that the efficacy signal was replicated in the IGA-TS, a key measure in Phase 3 clinical trials. The company plans to conduct a consolidated analysis of data from its domestic Phase 1 and Phase 2a trials, as well as global Phase 2b Parts 1 and 2, to finalize its strategy for submitting an Investigational New Drug (IND) application for the Phase 3 clinical trial—with a focus on IGA-TS—and to advance discussions on global technology transfer.

The company explained that it is also reviewing the reasons behind the high placebo response rate observed in Part 2. It is currently analyzing potential confounding factors, such as the characteristics of patients in the placebo group, the distribution of lesion severity, the impact of topical treatments and skin care, and inter-rater variability. For future clinical trials, the company plans to refine patient selection criteria and strengthen evaluator training and the standardization of assessment tools.

Regarding safety, the company plans to incorporate the findings into its follow-up development strategy as soon as the final analysis of the Phase 2b Part 2 trial is completed. The company noted that no specific safety adverse events were observed in the previous Phase 1 and Phase 2a trials, nor in the global Phase 2b Part 1 trial.

Shaperon Inc. representative stated, “The results of this IGA-TS analysis are significant in that they reaffirm Nugel’s potential for improvement in key Phase 3 clinical trial endpoints,” adding, “We will thoroughly review the confounding factors that influenced the placebo group’s response and pursue follow-up development and global technology transfer strategies by standardizing evaluation methods and refining the clinical trial design.”