Bridge Biotherapeutics announced the results of its multinational Phase 2a clinical study (NCT 04596293) to evaluate the safety and efficacy of orally administered BBT-401 in subjects with active ulcerative colitis (UC). The Phase 2a mid-to-high dose cohort study included 38 patients enrolled at 37 clinical sites located in the U.S., New Zealand, the Republic of Korea, Poland, and Ukraine. During the induction and extension phases of the study, both groups treated with BBT-401 (800mg) once daily and twice daily failed to meet the primary efficacy endpoint of the clinical response rate at Day 57, as measured by reduction of >=3 points and a >=30% improvement from the baseline of total Mayo score. Clinical response rates (95% CI) on Day 57, based on centrally read Mayo endoscopic subscores, were 63.6% (30.8%, 89.1%) for the placebo twice daily treatment group; 54.5% (23.4%, 83.3%) for placebo once and BBT-401 once daily treatment group; and 54.5% (23.4%, 83.3%) for the BBT-401 twice daily treatment group. The study met the primary safety endpoint. The primary safety endpoints were adverse events (AEs) and serious adverse events (SAEs). The safety and tolerability profile observed in the Phase 2a study was consistent with the safety profile of BBT-401 demonstrated in previous studies. Prior to the Phase 2a study, the company first explored drug efficacy and safety in patients with ulcerative colitis
through a BBT-401 low-dose cohort study, conducted in the United States from April 2019 to July 2020. After the low-dose cohorts, the company developed a new formulation of BBT-401 that improved drug delivery to the colon and ileum. The Phase 2a, mid-to-high dose study confirmed that drug delivery distribution profiles were improved. Based on the drug delivery result, the company will continue to seek opportunities for enhancing the drug delivery to the intestine with further formulation improvements to BBT-401.