Nuocheng Jianhua (09969): Positive top-line results of the phase II phase II adaptation study of SOFICITINIB (ICP-332) for non-segmental vitiligo

Zhitong Finance App News, Nuocheng Jianhua (09969) announced that the new-generation oral tyrosine kinase 2 inhibitor soficitinib (ICP-332) independently developed by the company successfully reached its main end in phase II phase II of the ongoing phase II/III adaptive clinical study for adult patients with non-segmental vitiligo.

The ongoing phase II/III study is a randomized, double-blind, placebo-controlled, parallel-group, adaptive-designed, multicenter clinical study to evaluate the efficacy and safety of soficitinib (ICP-332) in patients with non-segmental vitiligo.

The study included a phase II portion followed by a phase III portion. This announcement relates to the headlining results of the Phase II section.

Phase II reached the primary endpoint, showing that the Soficitinib (ICP-332) treatment group achieved statistically significant and clinically significant improvements over the placebo group at week 24. Treatment with Soficitinib (ICP-332) also showed consistent efficacy at multiple secondary endpoints.

At week 24, soficitinib (ICP-332) treatment showed a significant improvement in the facial vitiligo area score index (F-VASI) compared to baseline levels. The least square mean percentage change was 38.8% lower than baseline in the once-daily 80 mg dose group, 41.2% in the daily 120 mg dose group, and 2.2% in the placebo group. The differences between the two Soficitinib (ICP-332) dosage groups and the placebo group were statistically significant (P<0.0001).

The safety of Soficitinib (ICP-332) is consistent with previous clinical findings. The treatment was well tolerated, and no new safety signals were found.

The detailed efficacy and safety results of the Phase II section will be announced at subsequent international academic conferences and submitted to peer-reviewed medical journals.

The ongoing Phase II/III adaptation studies will continue in accordance with the research programme. The company plans to communicate the Phase II results with regulators and continue to advance clinical development of soficitinib (ICP-332) to treat non-segmental vitiligo.