Bambusa Therapeutics has completed patient enrolment in its Phase Ib/IIa trial evaluating BBT001 as a treatment for moderate-to-severe atopic dermatitis (AD).
The randomised, double-blind, placebo-controlled trial is being conducted at sites in New Zealand and the US.
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Bambusa expects to announce top line results from the four-week treatment study by mid-2026.
The trial randomised patients in a 2:1 ratio to the BBT001 450mg arm versus placebo, dosed once every two weeks over four weeks.
Primary endpoints are safety and tolerability. The trial will also assess exploratory efficacy and biomarker endpoints.
These include percentage change from baseline in Eczema Area and Severity Index (EASI), Peak Pruritus Numerical Rating Scale (PP-NRS) score, and thymus and activation-regulated chemokine (TARC) levels.
Bambusa Therapeutics founder and CEO Shanshan Xu said: “We are thrilled with the rapid enrolment 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.
“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.”
In addition to the completed four-week AD study, BBT001 is being assessed in an ongoing 12-week AD trial and a 14-week chronic spontaneous urticaria (CSU) study.
BBT001 remains investigational, with no approvals in any country to date. It is a multi-targeting, half-life extended bispecific antibody designed to block both IL-4Rα and IL-31 signalling, aiming to address type 2 inflammation and itch pathways.
In February 2025, Bambusa announced the dosing of its first healthy volunteers as part of a Phase I trial of its half-life extended bispecific antibody therapy for AD.
