Bosakitug

中国南京和美国纽瓦克，2025年6月23日——博奥信生物技术（南京）有限公司（简称：“博奥信”），一家处于临床阶段的全球化创新生物技术公司，宣布其合作伙伴Aclaris Therapeutics（NASDAQ：ACRS）已启动其潜在的同类最佳双特异性抗体ATI-052（BSI-502 TSLP/IL-4R 双抗）的1a/1b期阶段临床试验。该试验将包括在健康受试者中进行的1a期单剂量递增试验与多剂量递增试验（SAD/MAD）部分，随后计划将进行1b期概念验证部分。 “这是ATI-052开发过程中的重要里程碑，该抗体是公司独具特色的强效双特异性抗TSLP/IL-4R抗体。我们近期已获得美国食品药品监督管理局（FDA）的临床试验申请（IND）批准，”Aclaris首席医疗官杰西·霍尔博士（Dr. Jesse Hall）表示。“这种新型双特异性抗体设计旨在对上游和下游靶点展现高亲和力结合，实现双重阻断，从而选择性抑制核心促炎通路。该通路与Th2介导的炎症和过敏性疾病密切相关。我们预计将于2025年底完成1a期的单剂量递增试验（SAD）和多剂量递增试验（MAD）部分，并于2026年初公布顶线结果，随后于2026年下半年公布1b期的顶线结果。” 随机、双盲、安慰剂对照的1a期研究旨在评估皮下给药的ATI-052在健康受试者中的安全性、耐受性、药代动力学和药效学，最初采用单次剂量递增（SAD）和多次剂量递增（MAD）给药。预计在完成1a期SAD/MAD阶段后，将进行针对最多两种未披露适应症的1b期概念验证评估。 双特异性抗体经过工程化改造，具有两个不同的结合域，能够同时结合两个靶点。这种双重结合和双通路抑制特性可能比传统的单克隆抗体更有效地增强疗效，并有望广泛应用于多种免疫调节疾病的治疗。 关于ATI-052(BSI-502) ATI-052（BSI-502）是一种在研的人源化抗TSLP和抗IL-4R双特异性抗体，其对上游胸腺基质淋巴细胞生成素（TSLP）受体信号传导和下游白细胞介素-4受体（IL-4R）活化均表现出高结合亲和力和双重阻断作用，从而抑制这一核心促炎通路。ATI-052 靶向炎症级联反应顶端的 TSLP，并通过靶向 IL-4R 同时阻断下游的 IL-4 和 IL-13。这两种细胞因子在 Th2 介导的炎症和过敏性疾病中发挥关键作用。ATI-052展现出潜在的同类最佳疗效，其TSLP抗原结合片段（Fab）区域与bosakitug（ATI-045/BSI-045B）相同，但经过工程化改造可以更紧密地结合新生儿Fc受体（FcRn），有望延长药物半衰期。ATI-052具备治疗多种特应性、免疫性及呼吸道疾病的潜力。2024年11月，博奥信将ATI-052（BSI-502）在大中华区以外的产品开发和商业化权益授权给Aclaris，博奥信保留大中华区的产品开发和商业化权益。 关于Aclaris Therapeutics Aclaris Therapeutics是一家临床阶段的生物制药企业，致力于开发创新候选药物管线，以满足免疫炎症疾病患者对理想治疗方案的需求。公司通过强大的研发引擎构建了覆盖多阶段的候选产品组合。如需了解更多信息，请访问www.aclaristx.com或在X（原Twitter）上关注@AclarisTx 以及在LinkedIn上关注Aclaris 。 关于博奥信 博奥信是一家全球临床阶段的生物技术公司，致力于开发创新的抗体疗法，以改善免疫和肿瘤疾病患者的治疗效果。公司依托自主研发的核心技术平台，包括H³抗体发现平台、SynTracer® HT内吞平台以及Flexibody® 双特异性抗体平台，开发出高度差异化的创新药物，解决全球范围内尚未满足的医疗需求。通过“发现-开发-合作”的灵活模式，博奥信已建立了10项全球合作项目，其中8个项目已经进入临床阶段，包括单克隆抗体、双特异性抗体和抗体药物偶联物（ADC）。博奥信在美国、中国和澳大利亚设有运营机构。更多信息，请访问www.Biosion.com。 关于前瞻性陈述的警示性声明 本新闻稿中，除描述历史事实的陈述外，其他任何陈述均可能构成《1995年私人证券诉讼改革法案》中所定义的前瞻性陈述。此类陈述可通过“预期”、“相信”、“预计”、“打算”、“可能”、“计划”、“潜在”、“将”等词汇及类似表述识别，并基于Aclaris当前的信念和预期。这些前瞻性陈述包括对ATI-052开发计划的预期，包括报告1a期和1b期试验结果的时间安排，1b期试验评估ATI-052在最多两个未披露适应症中的潜力， ATI-052作为最佳抗TSLP/IL-4R双特异性单克隆抗体的潜力，以及ATI-052的治疗潜力。这些陈述涉及可能导致实际结果与陈述中反映的结果存在重大差异的风险和不确定性。可能导致实际结果与陈述内容存在重大差异的风险和不确定性包括临床试验固有的不确定性、Aclaris对第三方的依赖（其可能无法始终完全控制）、 Aclaris能否以商业合理条款建立战略合作伙伴关系，宏观经济环境的不确定性，以及Aclaris在截至2024年12月31日的年度10-K表格年度报告“风险因素”部分中描述的其他风险和不确定性，以及Aclaris不时向美国证券交易委员会提交的其他文件中描述的风险和不确定性。这些文件可在Aclaris网站（www.aclaristx.com）“投资者”部分的“SEC文件”页面查阅。任何前瞻性陈述仅反映本新闻稿发布之日的观点，且基于Aclaris截至本新闻稿发布日可获得的信息。Aclaris不承担更新任何前瞻性陈述的义务，无论是否基于新信息、未来事件或其他原因。

- Bosakitug is a Potential Best-in-Class Investigational Monoclonal Antibody with Demonstrated Superior Potency, Residence Time, and Affinity to Thymic Stromal Lymphopoietin (TSLP) - - Top Line Results Expected in the Second Half of 2026 - June 02, 2025 -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that it has initiated a randomized, double-blind, placebo-controlled Phase 2 trial of bosakitug (ATI-045) in patients with moderate-to-severe atopic dermatitis (AD). “We are excited to initiate this Phase 2 trial following the strong single arm Phase 2a results in patients with moderate-to-severe AD,” said Dr. Jesse Hall, Chief Medical Officer of Aclaris. “In that trial, bosakitug demonstrated improvements in efficacy measures at week 26 including EASI-75 scores in 94% of participants and clear or nearly clear skin in 88% of participants as measured by IGA scores of 0/1. With demonstrated superior potency and residence time, and unique TSLP binding characteristics, we believe that bosakitug is competitively positioned as a potential best-in-class anti-TSLP therapeutic monoclonal antibody. We expect to provide top line results from this trial in the second half of 2026.” This randomized, double-blind, placebo-controlled global Phase 2 trial is designed to evaluate the efficacy and safety of bosakitug in approximately 90 patients with moderate-to-severe atopic dermatitis. The primary endpoint is percent change from baseline in Eczema Area and Severity Index (EASI) at week 24. Secondary endpoints at week 24 include EASI response (EASI-50, EASI-75, EASI-90), validated Investigator Global Assessment (IGA) response, body surface area (BSA) response, and Peak Pruritus Numerical Rating Scale (PP-NRS) score, relative to baseline. Safety and tolerability will also be assessed. Bosakitug is an investigational humanized anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody that specifically binds to human TSLP, blocking its interaction with the receptor complex and disrupting signal transduction. This mechanism prevents immune cells targeted by TSLP from releasing proinflammatory cytokines. Bosakitug has potential best-in-class properties, including a very high affinity to TSLP, very high potency, an extremely low dissociation rate from TSLP leading to long residence time and enhanced neutralization activity, and a half-life that can potentially support an extended dosing interval. Bosakitug has the potential to treat a variety of atopic, immunologic, and respiratory diseases. Aclaris has the exclusive worldwide rights to bosakitug, excluding Greater China. TSLP is an alarmin - a cytokine that is a master regulator of Type 2 (Th2) immune response at the barrier surfaces of skin and the respiratory/gastrointestinal tract in major allergic and inflammatory diseases - that has been validated as a relevant therapeutic target. TSLP drives eosinophilic and neutrophilic inflammation and acts on a wide variety of adaptive, innate, and structural cells, and is involved in induction phase and effector phase as well as non-Th2 processes. Since TSLP sits at the top of the inflammatory cascade, it activates downstream targets such as IL-4, IL-5, IL-13, IL-17, and other molecules elaborated from T cells like CCL17. The expression of TSLP is elevated in individuals with respiratory and skin diseases. Atopic dermatitis (AD) is the most common type of eczema, affecting approximately 10 million children and 17 million adults in the United States. Worldwide prevalence estimates that AD affects over 200 million people worldwide. It is estimated that 1 in 10 individuals will develop eczema during their lifetime. Common symptoms include dry, cracked, itchy patches of skin or small raised bumps, that can occur anywhere on the body. The affected skin can become inflamed, warm, thickened, and damaged with prolonged scratching. A study by Asthma and Allergy Foundation of America noted that about 40% of those affected with the disease have moderate or severe symptoms. AD can significantly affect a patient’s quality of life, with patients with moderate-to-severe AD having a higher prevalence of social dysfunction and sleep impairment. Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of product candidates powered by a robust R&D engine. The content above comes from the network. if any infringement, please contact us to modify.