Company Overview and Strategy - Aclaris is developing therapeutic franchises to address gaps in important Immune and Inflammatory (I&I) diseases, focusing on patient-driven innovation [1, 8] - The company anticipates having three clinical programs in 2025 and four in 2026, with 2026 being an important year for potential inflection points [11] - Aclaris expects its cash runway to extend into the second half of 2028, supporting its preclinical and clinical development plans [11, 14] Pipeline and Programs - Aclaris's pipeline includes Bosakitug (ATI-045), a monoclonal antibody targeting TSLP, ATI-052, a bispecific antibody targeting both TSLP and IL-4Rα, and ATI-2138, an oral inhibitor of ITK/JAK3 [14] - ATI-2138's Phase 2a open-label trial in Atopic Dermatitis (AD) achieved primary and key secondary endpoints, validating ITK as a therapeutic target; at week 12, 63% of patients experienced a ≥4-point improvement in worst itch [14, 103] - Bosakitug is currently in a two-arm placebo-controlled Phase 2 trial, while ATI-052 is in a Phase 1a/1b SAD MAD program with ongoing dosing [14] - The company is developing next-generation ITK selective inhibitors and bispecific antibodies, with potential for IND submissions starting in 2026 [14, 61] Market Opportunity and Technology - The total addressable market for select Th1, Th2, and Th17-mediated diseases is projected to be in the range of $0 to $70 billion globally from 2028-2034 [16] - Aclaris is leveraging its KINect® Technology Platform to target approximately 60% of the Kinome, with the annual sales of kinase drugs in 2024 at $62.8 billion and a market opportunity of $88.6 billion in 2029 [28, 30] - The global healthcare spending in autoimmune diseases in 2024 was $215 billion, with a global AI disease therapeutics market opportunity of $396 billion by 2030 [38] - Multi-specific antibodies had annual sales of $12.6 billion in 2024, highlighting an opportunity for best-in-class multi-specific antibodies for autoimmune and inflammatory diseases [38]

Soquelitinib作用机制和潜力 - Soquelitinib 是一种 First-in-Class 的免疫调节剂，在癌症和免疫疾病领域具有广泛的机会[4] - Soquelitinib 通过阻断 ITK 信号通路，能够调节 Th1/Th2/Th17 细胞的平衡，从而影响多种炎症细胞因子的产生[11, 29] - ITK 抑制剂具有广阔的治疗潜力，包括肿瘤免疫治疗、免疫疾病、肺部炎症、胃肠道疾病、纤维化疾病和皮肤病等[7] - Corvus 团队的领导成员曾参与 rituximab 和 ibrutinib 的开发[5] Soquelitinib 在 Atopic Dermatitis (AD) 临床试验中的结果 - 在 AD 的 Phase 1 临床试验中，Soquelitinib 在 Cohorts 1 和 2 中显示出 54.6% 的 EASI 平均降低[42] - Cohort 3 的 EASI 平均降低为 64.8%[42] - Cohort 3 中，50% 的患者在第 28 天实现了 PP-NRS 评分至少降低 4 分，表明瘙痒症状得到显著改善[53] - 在接受 Soquelitinib 治疗的患者中，75% 在 EASI 50 中有所改善，83% 在 EASI 50 中有所改善[42] - 29% 的患者在 EASI 75 中有所改善，50% 的患者在 EASI 75 中有所改善[42] - 4% 的患者在 EASI 90 中有所改善，8% 的患者在 EASI 90 中有所改善[42] - 21% 的患者 IGA 0 或 1 中有所改善，25% 的患者 IGA 0 或 1 中有所改善[42] Soquelitinib 的安全性 - 在 Cohorts 1、2 和 3 中，Soquelitinib 表现出良好的安全性和耐受性，未发生严重不良事件[49] - 38.9% 的 Soquelitinib 治疗患者出现不良反应，而安慰剂组为 25%[49] AD 市场机会 - G7 国家有大约 30 million 的 AD 患者，其中约 3 million 为中重度患者，但只有 10% 接受了先进疗法治疗[34] - AD 市场预计到 2030 年将达到 280 亿美元[34]