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– 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 –
– Bambusa plans to announce topline results from the placebo-controlled Phase 1b/2a trial of BBT001 in moderate-to-severe AD in mid-2026 –
– 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 –
BOSTON, April 30, 2026 /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). The Company plans to announce topline results from the 4-week treatment study in the middle of 2026.
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. 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.
“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. 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.”
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.
BBT001 is an investigational therapy that is not approved for any use in any country.
About 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 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.
About Bambusa Therapeutics
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. 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.
- 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.
- 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).
- BBT003 and BBT004 are preclinical programs focused on gastroenterology and rheumatology, respectively.
For more information, please visit www.bambusatx.com. Follow Bambusa on LinkedIn.
