The biotech firm finished recruiting participants for a Phase 1b/2a trial of BBT001, a potential treatment for atopic dermatitis.
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.
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