Bridge Biotherapeutics Inc (288330 KQ), a Korea-based clinical stage biotech company, has confirmed through its first cohort study of the Phase 2a trial, the safety and efficacy profiles of BBT-401 in active ulcerative colitis patients, it was reported on Tuesday.
The company says that the study revealed a competitive level of efficacy when indirectly compared to TD-1473, another gut-selective oral drug candidate for ulcerative colitis treatments.
The firm also revealed the study results from the Simulator of the Human Intestinal Microbial Ecosystem model, which proved the improved drug delivery performance of BBT-401's optimised formulation. The product's improved formulation has indicated an improved drug delivery mechanism (exceeding 80%) to the end of the small intestine, as shown via the SHIME model. The company is increasing the administered dose in the upcoming cohorts and further evaluating the safety and efficacy profile of BBT-401. It will increase the number of trial sites to around 40 in the US, South Korea, Poland and the Ukraine. Each cohort is to enrol 12 patients and the efficacy will be assessed individually for all participants.
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