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InventisBio Announces Positive Phase 2 Study Results for D-2570 (TYK2 Inhibitor) in Patients With Moderate to Severe Plaque Psoriasis

InventisBio Announces Positive Phase 2 Study Results for D-2570 (TYK2 Inhibitor) in Patients With Moderate to Severe Plaque Psoriasis

InventisBio宣布D-2570(TYK2抑制剂)用于中重度鳞屑病患者的2期研究结果呈积极态势
PR Newswire ·  2024/12/03 03:44

– D-2570 demonstrates robust efficacy and favorable safety profile, achieving skin clearance comparable to leading biologics –

D-2570表现出强大的疗效和良好的安全性,达到与领先生物制品相当的皮肤清除效果。

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.

上海,2024年12月3日 / 美通社 / -- InventisBio有限公司今天宣布D-2570(TYK2激酶的口服选择性抑制剂)在中重度斑块型银屑病患者的2期临床试验中取得了令人鼓舞的结果。随机、多中心、双盲、安慰剂对照研究表明,D-2570在改善皮肤清除方面取得了显著的疗效,同时保持良好的安全性。

Key Findings:

主要结果:

≥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.

在所有三个剂量组中,接受D-2570治疗的患者有≥85%在第12周时达到了PASI 75(银屑病面积和严重性指数的改善75%或以上),而安慰剂组为12.5%。

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.

接受高剂量D-2570的患者中,有50%在第12周时达到了PASI 100(完全皮肤清除),而安慰剂组为2.5%。

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.

PASI 90和静态医生全球评估(sPGA)0/1的反应也显著优于安慰剂,分别在高剂量组中为77.5%和87.5%,而在安慰剂组中分别为5.0%和20%。

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.

该试验共招募了161名患者,随机分为三种D-2570剂量或安慰剂。所有D-2570剂量组中达到PASI 75的患者比例明显大于安慰剂组(p

Safety Profile:

安全性评估:

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.

D-2570耐受性良好,没有报告严重不良事件。大多数不良事件为轻度到中度(CTCAE 1或2级),且没有发现新的安全信号。其安全性特征与已批准或当前处于临床开发中的其他TYK2抑制剂一致。

"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."

"中度至重度斑块型银屑病对患者仍然是一种重大负担,影响其身体健康和生活质量。D-2570展示了转变潜力,其疗效接近生物制品和IL-23靶向肽疗法,同时提供口服给药的便利性," InventisBio首席医疗官Dr. Ling Zhang说道。"我们致力于推动D-2570的开发,为生活在自身免疫疾病如银屑病和炎症性肠病的患者提供创新和有效的治疗选择。"

The complete data from this Phase 2 trial will be presented at upcoming scientific conferences.

这项第二阶段试验的完整数据将在即将召开的科学会议上发布。

About D-2570:

关于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.

D-2570是一种口服TYK2 JH2伪激酶域抑制剂,正在开发用于治疗包括银屑病在内的自身免疫疾病。通过选择性靶向TYK2,D-2570调节参与自身免疫炎症的关键细胞因子信号通路,提供生物制品疗法的潜在替代选择。

About InventisBio:

关于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.

InventisBio有限公司是一家临床阶段的生物科技公司,致力于发现和开发创新的小分子疗法,以治疗癌症、代谢和自身免疫疾病。通过利用强大的研究管线和关注未满足的医疗需求,InventisBio努力为全球患者提供变革性的治疗。

SOURCE InventisBio Inc.

来源:InventisBio Inc.

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