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South of the city, Korea, June 13, 2021 /PRNewswire/ – Bridge Biotherapeutics (KQ288330) today announced in its Proof of Principle (PoCP) study the first case of administration of BBT-401 to a high-dose patient to check the effectiveness of the drug in active ulcerative colitis Sex and safety (NCT04596293).
Phase IIa is a two-phase study that includes a randomized, double-blind, placebo-controlled induction phase, followed by an adaptive, double-blind expansion phase. This multinational study will evaluate the safety and effectiveness of the study drug in 36 patients with moderate to severe ulcerative colitis by activating 36 clinical trial sites in 5 countries/regions.United States, Republic of Korea, new Zealand, Poland with Ukraine).
The primary and secondary endpoints of the study included efficacy and safety assessments measured 8 weeks after dosing. These include the clinical response and remission rate based on the Mayo total score, and the endoscopic remission rate calculated based on the Mayo endoscopic score.
After the low-dose study was completed, this was the first hospitalization study of BBT-401, and the drug formulation was enhanced in terms of drug delivery and distribution to the ileum and distant colon.Evaluate enhanced drug delivery and distribution profiles through the in vitro simulator of the human gut microbial ecosystem (SHIME)®) Model.
BBT-401 is an investigational drug that may play a therapeutic role in inflammatory diseases such as ulcerative colitis. It is a small molecule Pellino-1 inhibitor with restricted gastrointestinal tract. As a scaffold protein, Pellino protein binds to proteins in the inflammatory signaling pathway, including IRAK4, MyD88, and RIPK1 under various physiological and pathological conditions.
“Given the improved drug formulation of BBT-401, we hope to observe enhanced treatment response in patients with moderate to severe UC,” and “our team will continue to focus on developing breakthrough treatments for patients with active ulcerative colitis. In addition, , Our goal is to disclose the interim data of the study in the first half of 2022,” James Lee, CEO of Bridge Biotherapeutics.
Combined with oral PoCP research, the mechanism test has been proved in new ZealandTo explore the efficacy and safety of rectal administration of BBT-401 in patients with active ulcerative colitis.
About Bridge Biotherapeutics
Bridge Biotherapeutics Inc., headquartered in South Korea, the United States and ChinaBridge Biotherapeutics is a listed clinical stage biotechnology company established in 2015. Bridge Biotherapeutics is engaged in the discovery and development of new therapies, focusing on ulcerative colitis, fibrotic diseases and cancer and other treatment areas with unmet needs. The company is developing BBT-401, a first-in-class Pellino-1 inhibitor for the treatment of ulcerative colitis, and BBT-877, a treatment for fibrotic diseases including idiopathic pulmonary fibrosis (IPF) A new type of autocrine motility factor inhibitor, and BBT-176, an effective targeted cancer therapy for non-small cell lung cancer (NSCLC) with C797S triple EGFR mutation.
Source: Bridge Biotherapeutics, Inc.
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