BridgeBio Begins Dosing Mid- and High-Dose Groups in Phase 2 Clinical Trial of Ulcerative Colitis Drug
Start of Dosing for Medium-High Dose Group in 'BBT-401' Trial... 10 Months After Completion of Low Dose Group Trial
[Asia Economy Reporter Jihee Kim] Bridge Biotherapeutics announced on the 14th that on the 11th (local time), it began dosing the first patient in the mid- to high-dose group trial of the multinational Phase 2 clinical trial for the ulcerative colitis treatment candidate 'BBT-401' in the United States. This marks the official start of dosing for the mid- to high-dose groups about 10 months after completing the low-dose group trial in Phase 2 last year.
In this mid- to high-dose group trial, the safety and efficacy of BBT-401 will be evaluated in a total of 36 patients with moderate to severe ulcerative colitis. The multinational clinical trial is being conducted simultaneously at approximately 36 clinical institutions across five countries: New Zealand, the United States, Poland, Korea, and Ukraine. Accordingly, an interim data release for the mid- to high-dose group trial of the BBT-401 multinational Phase 2 clinical trial is expected to be possible in the first half of next year.
After completing the low-dose group trial of BBT-401 in patients with active ulcerative colitis in the United States last year, Bridge Biotherapeutics developed a formulation that improves drug delivery rates to the key lesion site at the distal colon and proceeded with mid- to high-dose clinical trials. The improved new formulation demonstrated up to a 27 percentage point increase in drug delivery capability to the distal colon based on the SHIME model experiment, an in vitro method that replicates the structure of the human digestive system.
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Jungkyu Lee, CEO of Bridge Biotherapeutics, said, "It is meaningful that we can proceed with the mid- to high-dose group trial applying the improved formulation after completing the low-dose group trial of BBT-401 Phase 2 last year." He added, "Following the United States, where the first patient dosing has begun, we will strive to promptly recruit and dose clinical trial participants in the remaining countries."
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