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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: investors@bambusatx.com
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