- Bambusa's lead product candidate, BBT001 is a next-generation long-acting bispecific antibody targeting two clinically and commercially validated targets, IL-4Rα and IL-31 for the treatment of atopic dermatitis (AD) and other type 2 inflammatory skin diseases -

- 竹子公司的主要候选产品BBT001是一种下一代长效双特异性抗体，靶向两种在临床上和商业上都得到验证的目标，即IL-4Rα和IL-31，用于治疗特应性皮炎（AD）和其他2型炎症性皮肤病 -

- Bambusa plans to announce topline results from the placebo-controlled Phase 1b/2a trial of BBT001 in moderate-to-severe AD in mid-2026 -

- Bambusa 计划于 2026 年年中公布 BBT001 在中重度 AD 患者中的安慰剂对照 1b/2a 期试验的顶线结果 -

- Previously presented data from the Phase 1 healthy volunteer portion of the BBT001 trial support a potential best-in-disease profile with maintenance dosing of up to every 3 months -

- 先前在BBT001试验的第1阶段健康志愿者部分中提供的数据支持潜在的最佳疾病表现，维持剂量可达每3个月一次 -

BOSTON

波士顿

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April 30, 2026

2026年4月30日

/PRNewswire/ -- Bambusa Therapeutics, Inc. (Bambusa Therapeutics), a clinical-stage biotechnology company advancing next-generation bispecific antibodies for immunology and inflammation, today announced the completion of patient enrollment in its randomized, double-blind, placebo-controlled Phase 1b/2a trial of BBT001 in patients with moderate-to-severe atopic dermatitis (AD).

/PRNewswire/ -- 临床阶段生物技术公司Bambusa Therapeutics, Inc.（Bambusa Therapeutics）致力于开发用于免疫学和炎症的下一代双特异性抗体，今天宣布已完成其中度至重度特应性皮炎（AD）患者BBT001的随机、双盲、安慰剂对照1b/2a期试验的患者入组。

The Company plans to announce topline results from the 4-week treatment study in the middle of 2026..

公司计划在2026年年中公布为期4周的治疗研究的初步结果。

The Phase 1b/2a trial is a randomized, placebo-controlled study in patients with moderate-to-severe AD at clinical sites located in New Zealand and the United States. Patients were randomized 2 to 1 in favor of the BBT001 450-milligram treatment arm compared to placebo with a dosing interval of once every two weeks over a 4-week period.

1b/2a期试验是一项随机、安慰剂对照的研究，针对在新西兰和美国临床站点的中度至重度AD患者。患者以2:1的比例随机分配到BBT001 450毫克治疗组或安慰剂组，每两周一次给药，持续4周。

The primary endpoints of the trial are safety and tolerability. Exploratory efficacy and biomarker endpoints include the percent change in Eczema Area and Severity Index (EASI), Peak Pruritus Numerical Rating Scale (PP-NRS) score, and thymus and activation-regulated chemokine (TARC), relative to baseline..

试验的主要终点是安全性和耐受性。探索性疗效和生物标志物终点包括湿疹面积和严重程度指数 (EASI)、峰值瘙痒数值评分量表 (PP-NRS) 评分、胸腺和活化调节趋化因子 (TARC) 相对于基线的百分比变化。

'We are thrilled with the rapid enrollment of our first clinical trial of BBT001 in patients with moderate-to-severe AD, and we are looking forward to announcing topline results over the summer in 2026,' said Shanshan Xu, M.D., Ph.D., Founder & Chief Executive Officer of Bambusa Therapeutics. 'Data from this trial have the potential to establish clinical proof-of-concept for BBT001 in patients with AD.

“我们很高兴BBT001在中重度AD患者中的首次临床试验能够迅速招募，我们期待在2026年夏季公布初步结果，”Bambusa Therapeutics创始人兼首席执行官许珊珊医学博士表示。“这项试验的数据有可能为BBT001在AD患者中建立临床概念验证。”

This would be a significant milestone for Bambusa, and a true testament to our team's hard work in advancing the development of BBT001 over the past two years. We believe BBT001's multi-target mechanism provides the potential for it to be a highly differentiated, best-in-disease treatment option for patients with AD by improving overall clinical outcomes, quality of life, and dosing convenience compared to currently approved medicines.'.

这将是Bambusa的一个重要里程碑，也是我们团队过去两年在推进BBT001开发方面努力工作的真正证明。我们相信，与目前获批的药物相比，BBT001的多靶点机制通过改善整体临床结果、生活质量和用药便利性，使其有可能成为一种高度差异化、同类最优的AD治疗选择。

Alongside the 4-week AD study, BBT001 is being evaluated in an ongoing 12-week AD trial and a 14-week chronic spontaneous urticaria (CSU) study.

除了为期4周的AD研究外，BBT001还在进行中的为期12周的AD试验和为期14周的慢性自发性荨麻疹（CSU）研究中接受评估。

BBT001 is an investigational therapy that is not approved for any use in any country.

BBT001 是一种研究性疗法，尚未在任何国家获得任何用途的批准。

About BBT001

关于BBT001

Bambusa Therapeutics' lead clinical program, BBT001, is a first-in-class, multi-targeting, half-life extended bispecific antibody engineered to block both IL-4Rα and IL-31 signaling. By simultaneously addressing core type 2 inflammation and directly targeting pathways that drive itch, BBT001 is designed to provide faster, deeper, and more durable relief for patients with AD and other type 2 inflammatory skin diseases..

Bambusa Therapeutics的领先临床项目BBT001是一种首创的、多靶点、半衰期延长的双特异性抗体，旨在阻断IL-4Rα和IL-31信号传导。通过同时针对核心的2型炎症并直接靶向引发瘙痒的通路，BBT001旨在为特应性皮炎（AD）和其他2型炎症性皮肤病患者提供更快、更深入且更持久的缓解。

Bambusa has previously presented Phase 1 healthy volunteer data supporting a potential best-in-disease profile for BBT001, including a favorable safety profile, positive pharmacokinetic and pharmacodynamic activity, and the potential for maintenance dosing of up to every three months. Bambusa is currently evaluating BBT001 in multiple ongoing placebo-controlled clinical trials, including studies in patients with AD and CSU..

此前，Bambusa 公布了第一阶段健康志愿者数据，支持 BBT001 潜在的同类最佳疾病特性，包括良好的安全性、积极的药代动力学和药效学活性，以及最长可达每三个月一次的维持剂量潜力。Bambusa 目前正在多个正在进行的安慰剂对照临床试验中评估 BBT001，其中包括针对 AD 和 CSU 患者的研究。

About Bambusa Therapeutics

关于竹子疗法

Bambusa Therapeutics is a clinical-stage biotechnology company developing a portfolio of next-generation, multi-targeting medicines designed to transform patient care across chronic immunology and inflammation (I&I) diseases. The Company's bispecific antibody platform combines advanced protein engineering with half-life extension technology and high-concentration subcutaneous delivery to improve durability, convenience, and clinical differentiation.

竹生物科技是一家临床阶段的生物技术公司，致力于开发一系列下一代多靶点药物，旨在变革慢性免疫学和炎症（I&I）疾病的患者护理。公司双特异性抗体平台结合了先进的蛋白质工程、半衰期延长技术以及高浓度皮下递送技术，以提高持久性、便利性和临床差异化。

Bambusa's vision is to deliver transformative medicines for patients across every stage of life and help define the next era of I&I therapies..

竹子的愿景是为生命各个阶段的患者提供变革性的药物，并帮助定义下一代I&I疗法。

BBT001 is a first-in-class, half-life-extended bispecific antibody targeting IL-4Rα and IL-31 with best-in-disease potential. It is currently in Phase 1b/2a proof-of-concept development for AD and other type 2 inflammatory skin diseases.

BBT001 是一种同类首创、半衰期延长的双特异性抗体，靶向 IL-4Rα 和 IL-31，具有疾病最佳潜力。目前，它正处于针对特应性皮炎（AD）和其他 2 型炎症性皮肤病的 1b/2a 期概念验证开发阶段。

BBT002 is a first-in-class, half-life-extended bispecific antibody targeting IL-4Rα and IL-5 with platform-in-a-molecule potential. It is currently in Phase 1b/2a proof-of-concept development for type 2 inflammatory disorders including chronic obstructive pulmonary disease (COPD) and chronic rhinosinusitis with nasal polyps (CRSwNP)..

BBT002 是一种首创的、半衰期延长的双特异性抗体，靶向 IL-4Rα 和 IL-5，具有分子内平台潜力。目前，它正处于 1b/2a 期概念验证开发阶段，用于治疗 2 型炎症性疾病，包括慢性阻塞性肺疾病 (COPD) 和伴鼻息肉的慢性鼻窦炎 (CRSwNP)。

BBT003 and BBT004 are preclinical programs focused on gastroenterology and rheumatology, respectively.

BBT003 和 BBT004 分别是专注于胃肠病学和风湿病学的临床前项目。

For more information, please visit

更多信息，请访问

www.bambusatx.com

www.bambusatx.com

. Follow Bambusa on

关注Bambusa

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SOURCE Bambusa Therapeutics

来源：Bambusa Therapeutics

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