A First-in-Human, Phase 1a, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of STAR-0310 in Healthy Adult Participants

This is a randomized, double-blind, placebo-controlled, single ascending dose trial evaluating the safety, tolerability, PK, and immunogenicity of STAR-0310 in healthy adult participants. There are 4 planned cohorts and potentially up to 1 additional cohort which may comprise of healthy adult participants of Japanese descent.

开始日期2025-01-07

申办/合作机构

Astria Therapeutics, Inc.

100 项与 STAR-0310 相关的临床结果

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100 项与 STAR-0310 相关的转化医学

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100 项与 STAR-0310 相关的专利（医药）

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项与 STAR-0310 相关的文献（医药）

2026-03-01·BIODRUGS

The Role of OX40 Pathway Inhibition as a New Therapeutic Strategy for Atopic Dermatitis

Review

作者: Alvarenga, José Miguel ; Torres, Tiago ; Mohamed, Adam ; Oliveira Dos Santos, David ; Mohamed, Amir

Atopic dermatitis is a chronic inflammatory skin disease affecting approximately 15-20% of children and 2-10% of adults worldwide. Epidermal barrier dysfunction and immune dysregulation are central to its pathogenesis, creating a self-perpetuating cycle in which barrier disruption exacerbates inflammation, which in turn further impairs skin barrier integrity. The OX40/OX40L axis, involving the co-stimulatory receptor OX40 expressed on T cells and its ligand OX40L on antigen-presenting cells, plays a critical role in sustaining T cell-driven inflammatory responses in AD. Despite recent therapeutic advances, many patients remain inadequately controlled, and key unmet needs persist. Inhibitors of the OX40/OX40L pathway represent a novel therapeutic approach by modulating multiple effector and memory T-cell subsets implicated in disease pathogenesis. Amlitelimab, an anti-OX40L monoclonal antibody, has demonstrated sustained efficacy and a favorable safety profile in phase IIa and IIb trials. Rocatinlimab, targeting OX40, has also shown promising results in a phase IIb study and has progressed into multiple phase III trials, with supportive top-line data. In contrast, telazorlimab has shown more modest efficacy and has not advanced to later-stage development. Next-generation agents, including IMG-007, STAR-0310, APG990, and APG279, have been engineered with extended half-lives and attenuated antibody-dependent cellular cytotoxicity to support longer dosing intervals and improve tolerability. While these findings are encouraging, direct comparative studies among agents and versus established therapies are lacking, and long-term efficacy and safety data are still needed. This narrative review explores the role of the OX40/OX40L axis in atopic dermatitis pathogenesis and critically evaluates emerging therapies targeting this pathway, aiming to inform their future integration into clinical practice.

项与 STAR-0310 相关的新闻（医药）

2026-04-06

·特应性皮炎药媒

特应性皮炎停药就复发？这类OX40抑制剂从源头改写免疫记忆，药效可维持半年？

导语不少特应性皮炎（AD）患者最困扰的不是治疗无效，而是停药后很快复发。现有疗法大多在炎症发生后进行拦截，但致病性的免疫记忆T细胞仍然潜伏在体内。OX40/OX40L通路抑制剂是一类新机制药物，它不局限于抗炎，还尝试重塑免疫记忆，实现停药后的长效缓解。 01 停药后仍能维持疗效以抗OX40L单抗Amlitelimab为例，在IIb期临床试验中，患者接受最后一次治疗后，停药长达28周，仍有超过50%的患者维持了湿疹面积和严重程度指数改善75%（EASI-75）以及瘙痒缓解的状态。这种持久的停药后效应在现有生物制剂中较为少见，提示药物可能改变了疾病的自然进程。 02 作用上游开关，清除致病记忆T细胞 AD反复发作的核心在于记忆T细胞。这些细胞如同潜伏的隐患，再次接触过敏原时会迅速唤醒免疫反应。OX40受体主要表达在激活的T细胞上，OX40L配体表达在抗原呈递细胞上，两者结合会向T细胞发送强烈的共刺激信号，放大免疫反应。 OX40通路抑制剂在更上游阻断OX40与OX40L的结合，同时抑制Th1、Th2、Th17和Th22等多种致病性T细胞亚群的活化与扩增。更重要的是，它能选择性抑制致病性记忆T细胞的存活和扩增，清除免疫系统对过敏原的错误记忆。这解释了为何在血清药物浓度低于药理活性水平后，疗效仍能维持数月。 03 新一代药物的安全性优化与长效设计早期抗OX40抗体可能存在通过抗体依赖性细胞毒性（ADCC）直接杀伤T细胞的风险。新一代药物进行了工程化改造： l ADCC沉默技术：如IMG-007通过基因工程去除Fc段的杀伤功能，只阻断信号通路而不直接杀伤细胞，保护初始T细胞，降低感染风险。临床数据显示其安全性良好，未出现严重的药物相关不良事件。 l 超长半衰期技术：以STAR-0310为例，半衰期延长至约68天，普通抗体通常为10-14天。APG990半衰期约为60天。未来可能实现每3-6个月注射一次，显著减轻治疗负担。 l 联合策略探索：APG279尝试将抗IL-13药物与OX40L抑制剂结合，兼顾快速症状控制与长期疾病修饰。 04 特应性皮炎临床药物最新进展 04 l Amlitelimab（靶向OX40L）：2025至2026年，III期研究COAST 1、COAST 2及SHORE均取得积极结果，每4周或每12周给药可持续改善症状。 l Rocatinlimab（靶向OX40）：III期IGNITE和HORIZON研究发表于《柳叶刀》，在改善皮肤清除率和疾病严重程度方面达到主要终点。 l IMG-007（靶向OX40，ADCC沉默）：2b期ADAPTIVE试验于2025年7月完成首例患者给药，顶线结果预计2026年第四季度公布。 l STAR-0310（靶向OX40）：已完成健康志愿者I期研究，耐受性良好。您对这类新机制疗法有什么看法？欢迎在评论区留言交流。文中临床新药招募志愿者： 1.有望一年四针的OX40L单抗，赛诺菲新药Amlitelimab三期开启全国临床招募 2.7款新药汇总！特应性皮炎2026新药临床试验进展【全国招募】赛诺菲信达OX40L 单抗，司普奇拜单抗，达必妥头对头，IL-4Rα和TSLP双靶点等多种生物制剂正在开展临床。临床是由国家药监局审批通过，三甲医院专家随访，符合条件用药、体检均不收费，有一定补贴！三甲临床点击扫码报名进病友群真实反馈资讯往期文章推荐：打一针管12周的AD新药：Amlitelimab（OX40L）计划申报上市，安全耐药性如何？特应性皮炎停药易复发？OX40L/OX40通路或成长期控制新突破口《柳叶刀》发表OX40靶向新药罗卡替尼（rocatinlimab）积极结果，特应性皮炎治疗迎来新机制参考文献： [1]Oliveira dos Santos D, Mohamed A, Mohamed A, et al. The Role of OX40 Pathway Inhibition as a New Therapeutic Strategy for Atopic Dermatitis. BioDrugs. 2026. [2]Brooks SG, Lopez LM, Mashoudy KD, et al. Addressing Unmet Needs in Atopic Dermatitis: Evaluating Disease-Modifying Capabilities of Current and Emerging Therapies. Dermatitis. 2024. [3]Sadrolashrafi K, Guo L, Kikuchi R, et al. An OX-Tra Ordinary Tale: The Role of OX40 and OX40L in Atopic Dermatitis. Cells. 2024;13:587. 本文仅做参考，不提供任何诊疗意见，不构成对任何药物的推广或宣传，如有任何问题，请前往医院向专业医师咨询。部分材料和图片源于网络，侵删

临床3期临床2期临床结果临床1期抗体药物偶联物

2026-03-09

·得码学苑

不止是止痒：OX40通路抑制剂通过重塑免疫记忆实现特应性皮炎的长效缓解

特应性皮炎（AD）是一种以慢性、复发性炎症为特征的难治性皮肤病，其发病机制涉及复杂的免疫失调和皮肤屏障受损。在过去几年，针对中重度患者的治疗方案中，Janus激酶（JAK）抑制剂和抗IL-4/13生物制剂已成为临床主流选择，但部分患者仍存在对现有疗法反应不佳或耐受性差的问题。2026年发表在权威期刊《BioDrugs》（IF=6.9）上的一篇综述文章揭示了新的希望：OX40/OX40L通路抑制剂。这类新药的作用不再局限于阻断下游的炎症因子，而是扮演了免疫记忆重塑者的角色，试图从源头切断疾病复发的根基。这项基于最新临床试验的深度分析揭示，OX40抑制剂有望通过重塑免疫微环境，实现潜在的疾病修饰作用。一、从症状控制到长效缓解的临床跨越（一）突破停药即复发的困境 AD患者常面临治疗、缓解、停药、复发的循环折磨，这主要是因为现有疗法大多是在炎症发生后进行拦截，而未能彻底改变免疫系统的致病状态。最新的研究数据令人振奋，OX40通路抑制剂展现出了显著的停药后效应。以抗OX40L单抗Amlitelimab为例，在IIb期临床试验中，患者在接受最后一次药物治疗后，即使停药长达28周，仍有超过50%的患者维持了湿疹面积和严重程度指数（EASI）改善75%和瘙痒缓解的状态。这意味着药物可能有助于改变疾病的自然进程，而不仅仅是暂时压制了症状，这种持久的疗效在现有生物制剂中是较为少见的。（二）解决现有疗法无法满足的需求尽管JAK抑制剂起效迅速，但其带来的副作用风险限制了部分患者的使用；而靶向IL-4/13的生物制剂虽然安全，但在部分重症患者中疗效有限。外部研究指出，AD治疗领域目前关键的未满足需求在于缺乏能够诱导长期缓解且给药频率较低的药物。OX40抑制剂的出现填补了这一空白。临床试验显示，抗OX40单抗Rocatinlimab展现出良好的疗效。尽管早期研究显示每2周给药效果最佳，但目前的III期临床正致力于探索每4周一次的给药方案，以期在保证疗效的同时，有效降低患者的注射负担。二、OX40通路对免疫微环境的源头阻断（一）关停免疫反应的上游开关如果说IL-4和IL-13是引起皮肤瘙痒和红肿的炎症介质，那么OX40/OX40L通路就是启动这一过程的上游开关。OX40受体主要表达在激活的T细胞上，而OX40L配体表达在抗原呈递细胞上。当两者结合时，会向T细胞发送强烈的共刺激信号，从而放大免疫反应。传统疗法大多是在下游阻断单一因子，而OX40抑制剂则是直接在更上游阻断了OX40与OX40L的结合（图1），从而同时抑制了辅助性T细胞（Th）1、Th2、Th17和Th22等多种致病性T细胞亚群的活化与扩增。这种广谱的调节作用，使其在应对AD复杂的异质性炎症时更具优势。图1 OX40/OX40L上游开关的共刺激机制及不同靶向药物的阻断策略（二）清除致病的免疫记忆 AD之所以反复发作，核心在于记忆T细胞的存在。这些细胞如同潜伏的隐患，一旦再次接触过敏原，就会迅速唤醒免疫反应。外部文献指出，OX40通路是T细胞转化为长寿命记忆细胞的关键生存信号。综述证实，Rocatinlimab等药物能够选择性地抑制致病性记忆T细胞的存活和扩增，从而清除了免疫系统对过敏原的错误记忆。正是这种对免疫记忆的清除作用，解释了为何在血清药物浓度低于药理活性水平后，疗效仍能维持数月之久。三、下一代药物的分子优化与安全性在OX40药物的研发历程中，并非一帆风顺。早期的Telazorlimab虽然证实了通路阻断的安全性，但因疗效未达预期而止步不前。科学家正是吸取了这一经验，才研发出了分子结构更优化的后续药物。（一）更精准的安全性设计靶向免疫系统常常引发对误伤正常防御能力的担忧。早期的抗OX40抗体可能通过抗体依赖性细胞毒性（ADCC）直接杀伤T细胞，存在T细胞耗竭的风险。然而，下一代药物进行了精妙的分子工程改造。例如，新型抗体IMG-007通过基因工程去除了Fc段的杀伤功能，即ADCC沉默。它只负责阻断信号通路，而不直接杀伤细胞。这种设计既保留了对致病T细胞的抑制，又有效保护了初始T细胞，从而维持了患者对病毒和细菌的正常免疫防御能力，大大降低了感染风险。临床数据显示，IMG-007安全性良好，未出现严重的药物相关不良事件。（二）超长半衰期技术的应用为了进一步减轻患者的治疗负担，科学家们引入了YTE半衰期延长技术。以STAR-0310为例，其经过分子修饰后，半衰期延长至约68天，而普通抗体通常仅为10至14天。这意味着，未来的AD治疗可能只需每3到6个月注射一次，就能维持病情的长期稳定。APG990同样表现出色，其半衰期约为60天，支持3至6个月的给药间隔。这种给药频率的显著优化，将有助于提高患者的依从性和生活质量，解决了长期慢病管理中频繁注射的痛点。（三）双管齐下的联合策略此外，最新的临床研究还在探索联合治疗的策略。例如，名为APG279的在研疗法尝试将抗IL-13药物与OX40L抑制剂结合。这种策略旨在同时实现快速症状控制（下游抗炎）和长期疾病修饰（上游重塑），有望成为未来治疗的新高地。总结与展望综上所述，OX40/OX40L通路抑制剂的成功，不仅仅是因为它提供了一种新的抗炎手段，更因为它是一种具备疾病修饰潜力的疗法。它通过上游阻断全谱系炎症、清除致病免疫记忆，以及利用超长半衰期技术，系统性地解决了AD治疗中复发率高和给药频繁的两大难题。随着Amlitelimab和Rocatinlimab等药物III期临床试验的推进，以及IMG-007等下一代药物的加入，我们有理由相信，特应性皮炎的诊疗即将迎来继激素、生物制剂之后的又一次革新，开启重塑免疫、长效缓解的新时代。参考文献： [1]Oliveira dos Santos D, Mohamed A, Mohamed A, et al. The Role of OX40 Pathway Inhibition as a New Therapeutic Strategy for Atopic Dermatitis. BioDrugs. 2026. [2]Brooks SG, Lopez LM, Mashoudy KD, et al. Addressing Unmet Needs in Atopic Dermatitis: Evaluating Disease-Modifying Capabilities of Current and Emerging Therapies. Dermatitis. 2024. [3]Sadrolashrafi K, Guo L, Kikuchi R, et al. An OX-Tra Ordinary Tale: The Role of OX40 and OX40L in Atopic Dermatitis. Cells. 2024;13:587. 免责声明本微信文章中的信息仅供向医疗卫生专业人士提供科学信息，不可直接作为决策内容，得码学苑不对任何主体因使用本文内容而导致的任何损失承担责任。以上内容如涉版权请联系删除。

临床2期临床3期临床结果临床成功

2026-01-26

·GlobeNewswire-Health Care

BioCryst Completes Acquisition of Astria Therapeutics, Expanding Leadership in Hereditary Angioedema

Jan. 23, 2026 -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has completed its acquisition of Astria Therapeutics, Inc., initially announced on October 14, 2025. The transaction strengthens its position as a leader in hereditary angioedema (HAE) and enhances the company’s long-term growth trajectory. BioCryst adds navenibart, a late-stage, long-acting plasma kallikrein inhibitor currently in Phase 3 clinical development, to its HAE portfolio. The potential to be the first HAE therapy with every-three and every-six month dosing, combined with a high level of attack control, positions navenibart to significantly improve the treatment experience for HAE patients. With the addition of navenibart, BioCryst could offer both the leading oral therapy (ORLADEYO®) and a potentially best-in-class injectable prophylactic option – empowering physicians and patients with optimal choices for individualized care. BioCryst expects its commercial infrastructure, patient support platform, and deep HAE expertise will maximize the launch trajectory and peak revenue potential of navenibart with minimal incremental commercial investment. BioCryst also obtains Astria’s early-stage program for atopic dermatitis, STAR0310, for which the company plans to pursue strategic alternatives. The acquisition was completed for an implied transaction value of approximately $700 million, net of Astria’s cash at closing. BioCryst financed the cash portion of the acquisition with cash on hand and approximately $396.6 million (net of expenses) drawn from a financing facility with funds managed by Blackstone. In addition, at the closing of the transaction, BioCryst issued approximately 37.3 million shares of its common stock to Astria’s equity holders. Jill C. Milne, Ph.D., Co-Founder and Chief Executive Officer of Astria Therapeutics, has joined the BioCryst Board of Directors, further strengthening the company’s strategic leadership and rare disease expertise. In addition, John Ruesch, Senior Vice President, Pharmaceutical Sciences and Technical Operations at Astria, has joined BioCryst as Chief Technical Operations Officer, bringing deep CMC and product development expertise to support the advancement and commercialization of navenibart and other pipeline programs. BioCryst is a global biotechnology company focused on developing and commercializing medicines for hereditary angioedema (“HAE”) and other rare diseases, driven by its deep commitment to improving the lives of people living with these conditions. BioCryst has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of potential first-in-class or best-in-class oral small-molecule and injectable protein therapeutics for a range of rare diseases. The content above comes from the network. if any infringement, please contact us to modify.

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100 项与 STAR-0310 相关的药物交易

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