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InventisBio Announces Positive Phase 2 Study Results for D-2570 (TYK2 Inhibitor) in Patients with Moderate to Severe Plaque Psoriasis
2024-12-04 InventisBio Inc. HaiPress
– D-2570 demonstrates robust efficacy and favorable safety profile,achieving skin clearance comparable to leading biologics –
SHANGHAI,Dec. 3,2024 --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%,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.