• BBT-401 meets safety endpoints achieved in previous clinical studies
• The drug candidate did not achieve an improved clinical response compared to the placebo study group
• 54.5% of the treatment cohort exhibited a valid treatment response to orally administered BBT-401

SEONGNAM, South Korea, Feb. 21, 2023 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company focused on developing novel drugs for inflammation, fibrosis and oncology, 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.

James Lee, founder and CEO of Bridge Biotherapeutics, said the company is fully committed to continued development of BBT-401.

"We are grateful to the patients, investigators and medical professionals who participated in this clinical study," said Lee. "Although we did not achieve the primary efficacy endpoint in the treatment groups with BBT-401, we remain committed to the development of BBT-401. We believe this first-in-class Pellino-1 inhibitor remains an important candidate to address unmet medical needs in the treatment of ulcerative colitis. We are also encouraged by the safety and tolerability results of the study. Bridge Biotherapeutics will continue to advance development of BBT-401 to further improve the delivery of the drug and the treatment efficacy."

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.

About BBT-401

BBT-401, an investigational drug with the potential to exhibit treatment efficacy in inflammatory diseases such as ulcerative colitis, is a GI-tract restricted small molecule Pellino-1 inhibitor. Pellino serve as scaffold that bind to proteins in inflammatory signaling pathways, including IRAK4, MyD88 and to RIPK1, in various physio-pathological conditions.

About Bridge Biotherapeutics, Inc.

Bridge Biotherapeutics Inc., based in the Republic of Korea and the U.S. is a publicly-traded, clinical-stage biotech company founded in 2015. Bridge Biotherapeutics is engaged in the discovery and development of novel therapeutics, focusing on therapeutic areas with high unmet needs including ulcerative colitis, fibrotic diseases, and cancers. The company is developing BBT-401, a first-in-class Pellino-1 inhibitor for the treatment of ulcerative colitis, BBT-877, a novel autotaxin inhibitor for the treatment of fibrotic diseases including idiopathic pulmonary fibrosis (IPF), and BBT-176, a potent targeted cancer therapy for non-small cell lung cancer (NSCLC) with C797S triple EGFR mutations. Learn more at https://www.bridgebiorx.com/en.