InventisBio Co., Ltd. has announced positive results from its Phase 2 clinical trial of D-2570, an oral selective inhibitor of tyrosine kinase 2 (TYK2), for the treatment of moderate to severe plaque psoriasis. The study, a randomized, multicenter, double-blind, placebo-controlled trial, demonstrated that D-2570 achieved significant improvements in skin clearance with a favorable safety profile.
Efficacy Results
The Phase 2 trial enrolled 161 patients who were randomized to receive one of three dose levels of D-2570 or placebo. The primary endpoint, PASI 75 (a 75% or greater improvement in the Psoriasis Area and Severity Index), was achieved by a significantly greater proportion of patients in all D-2570 dose groups compared to the placebo group (p<0.001). Specifically, at week 12, ≥85% of patients across all three D-2570 dose groups achieved PASI 75, compared to only 12.5% in the placebo group.
Superior efficacy was also observed across secondary endpoints. Notably, 50% of patients in the high-dose D-2570 group achieved PASI 100 (complete skin clearance) by week 12, compared to 2.5% in the placebo group. Furthermore, PASI 90 responses were observed in 77.5% of patients in the high-dose group versus 5.0% in the placebo group, and static Physician’s Global Assessment (sPGA) 0/1 responses were seen in 87.5% and 20% respectively.
Safety and Tolerability
D-2570 was reported to be well-tolerated throughout the study. The majority of adverse events were mild to moderate in severity (CTCAE Grade 1 or 2), and no new safety signals were identified. The observed safety profile is consistent with other TYK2 inhibitors currently approved or in clinical development.
Clinical Significance
"Moderate to severe plaque psoriasis remains a significant burden for patients, affecting their physical health and quality of life. D-2570 has demonstrated a transformative potential with efficacy approaching that of biologics and IL-23 targeted peptide therapies, while offering the convenience of oral administration," said Dr. Ling Zhang, Chief Medical Officer of InventisBio. The company is committed to further developing D-2570 as a treatment option for autoimmune diseases, including psoriasis and inflammatory bowel diseases.
The complete data from this Phase 2 trial will be presented at upcoming scientific conferences. D-2570 represents a potential advancement in the treatment of psoriasis by offering an effective oral therapy with a favorable safety profile.
