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Bridge Biotherapeutics Announces Detailed Plans for the Phase 2a Study of BBT-401

2020.09.23

- The data from the low dose cohort confirms the safety and efficacy of BBT-401, Bridge Biotherapeutics’ novel drug candidate for ulcerative colitis patients
- Bridge Biotherapeutics discloses plans to initiate the mid to high dose cohort trials of the multi-national Phase 2a study by early next year


Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, Republic of Korea, announced that the company confirmed both the safety and efficacy profiles of BBT-401 in active ulcerative colitis patients through the first cohort study of the Phase 2a trial.

Through the first cohort study, the company confirmed the safety and efficacy profile of BBT-401, which has demonstrated a competitive level of efficacy when in-directly compared to TD-1473, another gut-selective oral drug candidate for ulcerative colitis treatments.

Additionally, the company disclosed the study results from the Simulator of the Human Intestinal Microbial Ecosystem (SHIME®) model, which proved the enhanced drug delivery performance of the optimized formulation of BBT-401.

As shown through the SHIME® model, the improved formulation of BBT-401 has shown an enhanced drug delivery mechanism (exceeding 80%) to the end of small intestine. Additionally, the drug has been well distributed within the colon and 9.4% and 27.4% of the total dose was found at the end of the colon, in the fed and fasted state each.

The company will escalate the administered dose in the upcoming cohorts and further assess the safety and efficacy profile of BBT-401. Additionally, the company will expand the number of trial sites to approximately 40 sites in the US, South Korea, Poland and the Ukraine. Each cohort (mid dose / high dose / placebo) will enroll 12 patients and the efficacy will be evaluated individually for all participants.

In addition to the exploratory phase 2a study of BBT-401, a proof of mechanism study for a rectally administered BBT-401 (NCT 04478825) will be initiated in New Zealand by the end of this year.

“Our team is highly encouraged by the data provided by the dynamic in vitro simulator model, which has shown enhanced drug delivery to the sigmoid colon,” and “we will continue to focus on the development of BBT-401 in order to deliver an improved treatment option for active ulcerative colitis patients around the world” said James Lee, CEO of Bridge Biotherapeutics.

BBT-401, a novel drug candidate discovered by SKKU (Sungkyunkwan University) and KRICT (Korea Research Institute of Chemical Technology), is a GI-tract restricted small molecule Pellino-1 inhibitor. Bridge Biotherapeutics licensed-in the worldwide exclusive rights to the compound in 2015 and licensed-out the rights in 22 Asian countries to Daewoong Pharmaceutical Co., Ltd. in 2018. Bridge Biotherapeutics is in pursuit of a worldwide partnership for the further development of BBT-401 as a novel treatment for ulcerative colitis.