BBT-001(Bambusa Therapeutics)

Detailed findings from a randomized, double-blind, placebo-controlled cohort presented by Eric Simpson, M.D., M.C.R., of Oregon Health & Science University Presentation brings previously announced clinical findings together with pharmacokinetic and biomarker evidence for scientific discussion Bambusa continues subcutaneous evaluation of BBT001 and preparations for Phase 2b development BOSTON, Oct. 19, 2026 /PRNewswire/ -- Bambusa Therapeutics, Inc. (Bambusa), a clinical-stage biopharmaceutical company developing next-generation, long-acting bispecific antibodies for immunology and inflammation (I&I), today announced the presentation of detailed proof-of-concept results for BBT001 in biologic-naïve patients with moderate-to-severe atopic dermatitis (AD) at the 2026 International Symposium on Atopic Dermatitis (ISAD). The results were presented by Eric Simpson, M.D., M.C.R., Professor of Dermatology and Director of Clinical Research at Oregon Health & Science University and a member of Bambusa's Scientific Advisory Board. The presentation builds on preliminary findings announced in July 2026, bringing together clinical response, safety, pharmacokinetic and biomarker results for discussion with the AD scientific community. "What makes these early findings worthy of further investigation is the deep and fast onset clinical activity observed in both skin disease and itch, considered alongside the pharmacokinetic and biomarker evidence," said Dr. Simpson. "Presenting these results in detail allows physicians and researchers to examine the study design and the relationship between clinical response and underlying pharmacology. Larger and longer studies will be important to establish whether this emerging profile translates into a meaningful advance for patients." "Sharing the detailed evidence behind BBT001 is an opportunity to engage the atopic dermatitis community and communicate our progress and excitement around the program," said Shanshan Xu, M.D., Ph.D., Co-Founder and Chief Executive Officer of Bambusa. "We want leading clinicians and investigators to examine the findings firsthand, contribute their perspectives and join us in advancing our planned Phase 2b study. Our ambition is to bring deep, durable control of skin disease and itch together with a more convenient treatment experience. As we move quickly from intravenous proof-of-concept to subcutaneous evaluation, collaboration with the AD community will be essential to rigorously testing BBT001's potential in a larger patient population." Study Design and Findings The biologic-naïve IV cohort is part of BBT001-001 (NCT06808477), a global, randomized, double-blind, placebo-controlled Phase 1 study conducted in the United States and New Zealand. Seventeen adult patients with atopic dermatitis were randomized 2:1 to receive doses of 450mg IV BBT001 or placebo on Days 1, 15, and 29. The clinical and scientific findings were summarized in the presentation titled "Safety and Efficacy of BBT001, a Novel Bispecific IL-4Rα/IL-31 Antibody: Proof-of-Concept Results from the Biologic-Naïve Portion of a Double-Blind, Placebo-Controlled Phase I Study in Patients with Atopic Dermatitis." Continued Development of BBT001 Bambusa recently initiated dosing in the subcutaneous cohort of BBT001-001, evaluating 12 weeks of treatment in biologic-naïve patients with moderate-to-severe AD. This cohort is distinct from the four-week IV proof-of-concept cohort presented at ISAD. The high-concentration subcutaneous formulation is designed to support convenient administration as infrequent as every three months. The company is also preparing a larger Phase 2b study to further characterize BBT001's efficacy, safety and dosing regimens. About BBT001 BBT001 is a potentially transformative, half-life-extended bispecific antibody engineered to block both IL-4Rα and IL-31 signaling. It is designed to address Type 2 inflammation and itch in a single therapy and is being evaluated in clinical studies in atopic dermatitis and chronic spontaneous urticaria. About Bambusa Therapeutics Bambusa Therapeutics is a clinical-stage biopharmaceutical company developing next-generation, long-acting, precision bispecific antibodies designed to redefine standards of care in immunology and inflammation and fundamentally improve patient quality of life. The company combines third-party, advanced antibody engineering and clinically and commercially validated biologic pathways into a single molecule formulated for high-concentration subcutaneous delivery to improve durability, convenience, and clinical differentiation beyond the current capabilities of existing monotherapies. Its pipeline includes BBT001 for inflammatory skin diseases; BBT002, a bispecific antibody targeting IL-4Rα and IL-5 in clinical development for Type 2 inflammatory disorders; and preclinical programs BBT003 and BBT004 focused on gastroenterology and autoantibody-driven autoimmune diseases, respectively. FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements including, but not limited to, statements regarding the timing and progress of Bambusa's ongoing and planned clinical trials. These statements are based on numerous assumptions and involve substantial risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievement to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements in this press release are as of the date of this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Contact: [email protected] SOURCE Bambusa Therapeutics 21% more press release views with Request a Demo

Detailed findings from a randomized, double-blind, placebo-controlled cohort presented by Eric Simpson, M.D., M.C.R., of Oregon Health & Science University 俄勒冈健康与科学大学的 Eric Simpson 医学博士、临床研究硕士（M.C.R.） presented 的一项随机、双盲、安慰剂对照队列研究的详细结果Presentation brings previously announced clinical findings together with pharmacokinetic and biomarker evidence for scientific discussion 本次报告将此前公布的临床发现与药代动力学及生物标志物证据相结合，以进行科学讨论Bambusa continues subcutaneous evaluation of BBT001 and preparations for Phase 2b development Bambusa 持续推进 BBT001 的皮下注射评估及 IIb 期临床开发准备工作BOSTON 波士顿, ，Oct. 19, 2026 2026年10月19日/PRNewswire/ -- Bambusa Therapeutics, Inc. (Bambusa), a clinical-stage biopharmaceutical company developing next-generation, long-acting bispecific antibodies for immunology and inflammation (I&I), today announced the presentation of detailed proof-of-concept results for BBT001 in biologic-naïve patients with moderate-to-severe atopic dermatitis (AD) at the 2026 International Symposium on Atopic Dermatitis (ISAD).. /美通社/ -- 专注于开发用于免疫学与炎症（I&I）领域的下一代长效双特异性抗体的临床阶段生物制药公司Bambusa Therapeutics, Inc.（简称“Bambusa”）今日宣布，将在2026年国际特应性皮炎研讨会（ISAD）上公布BBT001在未经生物制剂治疗的中重度特应性皮炎（AD）患者中的详细概念验证结果。The results were presented by Eric Simpson, M.D., M.C.R., Professor of Dermatology and Director of Clinical Research at Oregon Health & Science University and a member of Bambusa's Scientific Advisory Board. The presentation builds on 俄勒冈健康与科学大学皮肤科教授、临床研究主任，兼Bambusa科学顾问委员会成员的Eric Simpson医学博士、临床研究硕士（M.C.R.）公布了研究结果。该报告基于preliminary findings announced in July 2026 2026年7月公布的初步调查结果, bringing together clinical response, safety, pharmacokinetic and biomarker results for discussion with the AD scientific community. ，汇总临床反应、安全性、药代动力学和生物标志物结果，以便与阿尔茨海默病科学界进行讨论。'What makes these early findings worthy of further investigation is the deep and fast onset clinical activity observed in both skin disease and itch, considered alongside the pharmacokinetic and biomarker evidence,' said Dr. Simpson. 'Presenting these results in detail allows physicians and researchers to examine the study design and the relationship between clinical response and underlying pharmacology. 辛普森博士表示：“这些早期发现之所以值得进一步研究，是因为在皮肤疾病和瘙痒方面均观察到起效迅速且深入的临床活性，并结合药代动力学和生物标志物证据进行了综合考量。详细展示这些结果，使医生和研究人员能够审视研究设计以及临床反应与基础药理学之间的关系。”Larger and longer studies will be important to establish whether this emerging profile translates into a meaningful advance for patients.'. 更大规模、更长周期的研究对于确定这一新兴特征是否能转化为对患者具有临床意义的进展至关重要。'Sharing the detailed evidence behind BBT001 is an opportunity to engage the atopic dermatitis community and communicate our progress and excitement around the program,' said Shanshan Xu, M.D., Ph.D., Co-Founder and Chief Executive Officer of Bambusa. 'We want leading clinicians and investigators to examine the findings firsthand, contribute their perspectives and join us in advancing our planned Phase 2b study. “分享BBT001背后的详细证据，是一个与特应性皮炎社区互动、传达我们在该项目上的进展和热情的机会，”Bambusa联合创始人兼首席执行官徐姗姗博士表示。“我们希望领先的临床医生和研究者能够亲自审视这些发现，贡献他们的观点，并加入我们，共同推进计划中的IIb期研究。”Our ambition is to bring deep, durable control of skin disease and itch together with a more convenient treatment experience. As we move quickly from intravenous proof-of-concept to subcutaneous evaluation, collaboration with the AD community will be essential to rigorously testing BBT001's potential in a larger patient population.'. 我们的雄心是将针对皮肤疾病和瘙痒的深度、持久控制与更便捷的治疗体验相结合。在我们迅速从静脉给药的概念验证阶段推进至皮下给药的评估阶段之际，与特应性皮炎（AD）社群的合作对于在更大患者群体中严格验证BBT001的潜力至关重要。Study Design and Findings 研究设计与发现The biologic-naïve IV cohort is part of BBT001-001 (NCT06808477), a global, randomized, double-blind, placebo-controlled Phase 1 study conducted in the United States and New Zealand. Seventeen adult patients with atopic dermatitis were randomized 2:1 to receive doses of 450mg IV BBT001 or placebo on Days 1, 15, and 29.. 生物制剂初治的静脉给药队列属于BBT001-001（NCT06808477）研究，这是一项在美国和新西兰开展的全球性、随机、双盲、安慰剂对照的I期临床试验。17名成年特应性皮炎患者按2:1的比例随机分配，在第1天、第15天和第29天分别接受450mg静脉注射BBT001或安慰剂治疗。The clinical and scientific findings were summarized in the presentation titled 临床和科学发现已在题为的演示文稿中进行了总结'Safety and Efficacy of BBT001, a Novel Bispecific IL-4Rα/IL-31 Antibody: Proof-of-Concept Results from the Biologic-Naïve Portion of a Double-Blind, Placebo-Controlled Phase I Study in Patients with Atopic Dermatitis.' BBT001（一种新型IL-4Rα/IL-31双特异性抗体）的安全性和有效性：来自一项针对特应性皮炎患者的双盲、安慰剂对照I期研究中未接受过生物制剂治疗部分的concept验证结果。Continued Development of BBT001 BBT001的持续开发Bambusa recently initiated dosing in the subcutaneous cohort of BBT001-001, evaluating 12 weeks of treatment in biologic-naïve patients with moderate-to-severe AD. This cohort is distinct from the four-week IV proof-of-concept cohort presented at ISAD. The high-concentration subcutaneous formulation is designed to support convenient administration as infrequent as every three months. Bambusa 最近在 BBT001-001 研究的皮下注射队列中启动了给药，评估在中重度特应性皮炎（AD）且未接受过生物制剂治疗的患者中进行 12 周治疗的疗效。该队列不同于在国际特应性皮炎大会（ISAD）上展示的为期四周的静脉注射概念验证队列。高浓度皮下制剂旨在支持便捷的给药方式，给药频率可低至每三个月一次。The company is also preparing a larger Phase 2b study to further characterize BBT001's efficacy, safety and dosing regimens.. 该公司还在筹备一项规模更大的2b期临床试验，以进一步评估BBT001的疗效、安全性和给药方案。About BBT001 关于 BBT001BBT001 is a potentially transformative, half-life-extended bispecific antibody engineered to block both IL-4Rα and IL-31 signaling. It is designed to address Type 2 inflammation and itch in a single therapy and is being evaluated in clinical studies in atopic dermatitis and chronic spontaneous urticaria.. BBT001 是一种具有潜在变革性的半衰期延长型双特异性抗体，经工程化设计以同时阻断 IL-4Rα 和 IL-31 信号通路。该药旨在通过单一疗法同时解决 2 型炎症和瘙痒问题，目前正在特应性皮炎和慢性自发性荨麻疹的临床研究中进行评估。AboutBambusa Therapeutics 关于 Bambusa TherapeuticsBambusa Therapeutics is a clinical-stage biopharmaceutical company developing next-generation, long-acting, precision bispecific antibodies designed to redefine standards of care in immunology and inflammation and fundamentally improve patient quality of life. The company combines third-party, advanced antibody engineering and clinically and commercially validated biologic pathways into a single molecule formulated for high-concentration subcutaneous delivery to improve durability, convenience, and clinical differentiation beyond the current capabilities of existing monotherapies. Bambusa Therapeutics 是一家处于临床阶段的生物制药公司，致力于开发下一代长效、精准的双特异性抗体，旨在重塑免疫学与炎症领域的治疗标准，并从根本上改善患者的生活质量。该公司将第三方先进的抗体工程技术以及经临床和商业验证的生物制剂通路整合于单一分子中，并配制为高浓度皮下注射剂型，以提升药物的持久性、便利性以及在临床上的差异化优势，从而超越现有单药疗法的当前能力。Its pipeline includes BBT001 for inflammatory skin diseases; BBT002, a bispecific antibody targeting IL-4Rα and IL-5 in clinical development for Type 2 inflammatory disorders; and preclinical programs BBT003 and BBT004 focused on gastroenterology and autoantibody-driven autoimmune diseases, respectively.. 其研发管线包括用于治疗炎症性皮肤病的BBT001；处于临床开发阶段、靶向IL-4Rα和IL-5的双特异性抗体BBT002，用于2型炎症性疾病；以及分别聚焦于胃肠病学和自身抗体驱动的自身免疫性疾病的临床前项目BBT003和BBT004。FORWARD-LOOKING STATEMENTS 前瞻性陈述This press release contains forward-looking statements including, but not limited to, statements regarding the timing and progress of Bambusa's ongoing and planned clinical trials. These statements are based on numerous assumptions and involve substantial risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievement to be materially different from the information expressed or implied by these forward-looking statements. 本新闻稿包含前瞻性陈述，包括但不限于关于Bambusa正在进行的和计划中的临床试验的时间安排和进展的陈述。这些陈述基于众多假设，并涉及重大风险、不确定性和其他因素，可能导致实际结果、活动水平、绩效或成就与这些前瞻性陈述所表达或暗示的信息存在重大差异。The forward-looking statements in this press release are as of the date of this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.. 本新闻稿中的前瞻性陈述仅截至本新闻稿发布之日。因此，您不应依赖这些前瞻性陈述来代表我们在本新闻稿发布之日之后的任何日期的观点。Contact: 联系方式：[emailprotected] [email protected]SOURCE Bambusa Therapeutics 来源：Bambusa Therapeutics21 二十一% %more press release views with 更多新闻稿浏览量，借助Request a Demo 申请演示