Mar. 11, 2024 - InnoCare Pharma (HKEX: 09969; SSE: 688428), a commercial-stage biotech company, announced today that the latest data of the novel TYK2 inhibitor ICP-332 developed by the Company for the treatment of patients with moderate-to-severe atopic dermatitis (AD) has been released at the 2024 American Academy of Dermatology (AAD) Annual Meeting as a late-breaking oral presentation.

Late-breaking Oral Presentation

Efficacy and Safety of a Highly Selective Oral TYK2/JAK1 Inhibitor, ICP-332, in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase II, Randomized, Placebo-Controlled Trial

Abstract Number: 56157

This is a four-week multi-center (25 centers), randomized, double-blind, placebo-controlled Phase II clinical study to investigate the safety and efficacy of ICP-332 in patients with moderate-to-severe AD. 75 eligible AD patients were randomized into three groups: once daily oral ICP-332 80 mg, once daily oral 120 mg, and placebo respectively. 

ICP-332 demonstrated an outstanding efficacy and safety profile. ICP-332 achieved multiple efficacy endpoints in the 80 mg QD and 120 mg QD dosing groups respectively, including the percentage change in Eczema Area and Severity Index (EASI) score from baseline, EASI 50, EASI 75, EASI 90 (improvement of at least 50%, 75% and 90% in EASI score from baseline), Investigator's Global Assessment (IGA) 0/1 (score of 0 'clear' or 1 'almost clear') with >= 2 points improvement and Pruritus Numerical Rating Scale (NRS) score from baseline, etc. The mean percentage change from baseline in the EASI score reached 78.2% and 72.5% at the 80 mg QD and 120 mg QD groups respectively, both with a highly significant P value (p<0.0001), compared to 16.7% for patients receiving placebo. The percentages of patients achieving at least 75% improvement in EASI 75 were significantly higher in the ICP-332 80 mg QD (64.0%, p<0.0001) and 120 mg QD (64.0%, p<0.0001) groups than that of placebo (8.0%), which are better than the reported efficacies of multiple approved innovative drugs treated for 12 weeks or 16 weeks (not a head-to-head comparison). 

Notably, in the ICP-332 80 mg QD group, the response rates of EASI 90 and IGA 0/1 with >=2 points from baseline were 44.0% (P=0.0009) and 36.0% (P=0.0047) respectively, significantly better than the placebo group (4.0% and 4.0%).

ICP-332 demonstrated a rapid response, with the NRS score from baseline in the two treatment groups showing statistically significant improvement on day 2. The improvement trend continued over time until the end of treatment. With the improvement of pruritus, the quality of life of subjects in the two treatment groups was significantly elevated. From day 7, the DLQI scores of the treatment groups showed statistically significant improvement compared to the placebo group, and the improvement continued until the end of treatment.

ICP-332 was safe and well tolerated in AD patients. The overall incidence rates of adverse events (AEs) and AEs related to infections and infestations in the two treatment groups were comparable to the placebo group.

The 2024 AAD Annual Meeting is held from March 8 to 12 in San Diego, California, USA. It is the most influential international event in dermatology.