Clinical-stage biotechnology company Bambusa Therapeutics Inc announced on Thursday the completion of patient enrolment in its randomised, double-blind, placebo-controlled Phase 1b/2a trial of BBT001 in patients with moderate-to-severe atopic dermatitis (AD).
Topline results from the 4-week treatment study are expected to be released in the middle of 2026.
The Phase 1b/2a trial is a randomised, placebo-controlled study in patients with moderate-to-severe AD at clinical sites located in New Zealand and the United States. Patients were randomised 2 to 1 in favour of the BBT001 450-milligram treatment arm compared to placebo with a dosing interval of once every two weeks over a 4-week period.
Primary endpoints of the trial are safety and tolerability. Exploratory efficacy and biomarker endpoints include the percentage 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.
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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