Bridge Biotherapeutics Announces Launch of Patient Assay in Clinical Proof-of-Principle Study for Investigational Ulcerative Colitis Drug BBT-401
SEONGNAM, South Korea, June 13, 2021 / PRNewswire / – Bridge Biotherapeutics (KQ288330) today announced the first mid-to-high dose BBT-401 assay in its clinical proof-of-principle (PoCP) study to examine the efficacy and l Drug Safety in Active Ulcerative Colitis (NCT04596293).
Phase IIa is a two-phase study, with a randomized, double-blind, placebo-controlled induction phase, followed by a double-blind extension phase adaptive to response. This multinational study will assess the safety and efficacy profiles of the investigational drug in 36 patients with moderate to severe ulcerative colitis, activating 36 clinical trial sites in 5 countries (United States, Republic of Korea, New Zealand, Poland and Ukraine).
The primary and secondary endpoints of the study consist of efficacy and safety ratings measured 8 weeks after drug administration. These include the clinical response and remission rates determined from the total Mayo score as well as the endoscopic remission rate, which is calculated based on the Mayo endoscopic sub-score.
At the end of the low dose study, which was the first inpatient study for BBT-401, the drug formulation was improved in terms of drug delivery and distribution in the ileum and colon. distant. The improved drug administration and delivery profile was assessed via the Human Gut Microbial Ecosystem In Vitro Simulator (SHIME®) model.
BBT-401, an investigational drug with potential for therapeutic efficacy in inflammatory diseases such as ulcerative colitis, is a small molecule Pellino-1 inhibitor restricted to the gastrointestinal tract. Pellino proteins serve as scaffold proteins that bind to proteins in inflammatory signaling pathways, including IRAK4, MyD88, and RIPK1 under a variety of pathophysiological conditions.
“Given the improved drug formulation of BBT-401, we hope to observe improved therapeutic responses in patients with moderate to severe UC,” and “our team will continue to focus on the development of a breakthrough treatment for patients. with active ulcerative colitis. In addition, our goal is to release interim data from the study in the first half of 2022, “said James lee, CEO of Bridge Biotherapeutics.
In conjunction with the orally administered PoCP study, a mechanism proof trial was initiated in New Zealand, exploring the efficacy and safety of rectal administration of BBT-401 in patients with active ulcerative colitis.
About Bridge Biotherapeutics
Bridge Biotherapeutics Inc., based in the Republic of Korea, United States and China, is a publicly traded, clinical-stage biotechnology company founded in 2015. Bridge Biotherapeutics is engaged in the discovery and development of new therapies, focusing on therapeutic areas with unmet needs such as ulcerative colitis, diseases fibrotic and cancer. The company is developing BBT-401, a first inhibitor of Pellino-1 for the treatment of ulcerative colitis, BBT-877, a new inhibitor of autotaxin for the treatment of fibrotic diseases, including idiopathic pulmonary fibrosis (IPF) and BBT-176, a potent targeted therapy against non-small cell lung cancer (NSCLC) with C797S triple EGFR mutations.
SOURCE Bridge Biotherapeutics, Inc.