– D-2570 demonstrates robust efficacy and favorable safety profile, achieving skin clearance comparable to leading biologics –
SHANGHAI, Dec. 3, 2024 /PRNewswire/ — InventisBio Co., Ltd. today announced promising results from a Phase 2 clinical trial of D-2570, an oral selective inhibitor of the TYK2 kinase, in patients with moderate to severe plaque psoriasis. The randomized, multicenter, double-blind, placebo-controlled study demonstrated that D-2570 achieved significant efficacy in improving skin clearance while maintaining a favorable safety profile.
Key Findings:
≥85% of patients treated with D-2570 in all three dose groups achieved PASI 75 (75% or greater improvement in the Psoriasis Area and Severity Index) by week 12, compared to 12.5% in placebo group.
50% of patients receiving the high dose of D-2570 achieved PASI 100 (complete skin clearance) by week 12, compared to 2.5% in placebo group.
PASI 90 and sPGA 0/1 responses also significantly favored D-2570 over placebo, with 77.5% and 87.5%, respectively, in the high-dose group, versus 5.0% and 20%, respectively, in placebo group.
The trial enrolled 161 patients randomized to three dose levels of D-2570 or placebo. The primary endpoint of PASI 75 was achieved by a significantly greater proportion of patients in all D-2570 dose groups compared to placebo (p<0.001). Superior efficacy was observed across secondary endpoints, including PASI 90, PASI 100, and static Physician’s Global Assessment (sPGA) 0/1.
Safety Profile:
D-2570 was well-tolerated, with no serious adverse events reported. The majority of adverse events were mild to moderate (CTCAE Grade 1 or 2), and no new safety signals were identified. The safety profile was consistent with other TYK2 inhibitors that are approved or currently in clinical development.
"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. "We are committed to advancing the development of D-2570 to bring innovative and effective treatment options to patients living with autoimmune diseases such as psoriasis and inflammatory bowel diseases."
The complete data from this Phase 2 trial will be presented at upcoming scientific conferences.
About D-2570:
D-2570 is an oral TYK2 JH2 pseudokinase domain inhibitor under development for the treatment of autoimmune diseases, including psoriasis. By selectively targeting TYK2, D-2570 modulates key cytokine signaling pathways involved in autoimmune inflammation, offering a potential alternative to biologic therapies.
About InventisBio:
InventisBio Co., Ltd. is a clinical-stage biotech company dedicated to discovering and developing innovative small-molecule therapies for the treatment of cancer, metabolic and autoimmune diseases. By leveraging a strong research pipeline and a focus on unmet medical needs, InventisBio strives to deliver transformative treatments to patients worldwide.
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