BBT-401 / Bridge Biotherap, Daewoong Pharma - LARVOL DELTA

Bridge Biotherapeutics suffers steep revenue decline in 2023 (Korea Biomedical Review) - "The company's annual revenue plummeted to 100 million won ($74,878), marking a drastic 96.7 percent decrease compared to the previous year. This downturn is attributed to the absence of additional milestone payments following the receipt of a significant milestone in 2022 for the completion of phase 1 clinical trials in China for its ulcerative colitis drug candidate BBT-401."

Commercial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Bridge Bio abandons development of oral drug 'BBT-401', new drug for ulcerative colitis [Google translation] (Health Korea News) - "Attention is focused on the success of the world's only first-in-class ulcerative colitis new drug being developed. This is ‘BBT-401’, a Pellino-1 inhibitor being developed by Bridge Biotherapeutics, a Korean bio company....However, as the company is known to be considering changing the formulation, there are concerns that market expectations may disappear....If Bridge Bio changes the formulation of 'BBT-401' to suppositories, its value as a first-in-class drug is expected to drop significantly. This is because product differentiation cannot be expected in a situation where ulcerative colitis treatment in suppository form has already been released."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Bridge Biotherapeutics Presents Phase 2a Clinical Trial Results For BBT-401, a Drug Candidate to Treat Ulcerative Colitis (PRNewswire) - P2a | N=38 | NCT04596293 | Sponsor: Bridge Biotherapeutics, Inc. | "BBT-401 meets safety endpoints achieved in previous clinical studies...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)....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..."

P2a data • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis (clinicaltrials.gov) - P2 | N=38 | Completed | Sponsor: Bridge Biotherapeutics, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Feb 2023 ➔ Jul 2022 | Trial primary completion date: Nov 2022 ➔ May 2022

Trial completion • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

BridgeBio completes phase 2a drug administration for ulcerative colitis [Google translation] (Health in News) - "Bridge Biotherapeutics announced...that both the administration and the last institutional visit of subjects registered for the phase 2a mid-dose group clinical trial of BBT-401, which is being developed as a new drug candidate for ulcerative colitis, have been completed....The results of the test are expected to be announced in the fourth quarter of this year."

P2a data • Trial status • Inflammatory Bowel Disease • Ulcerative Colitis

Bridge Biotherapeutics, Inc (BIO 2022) - "is a publicly traded clinical-stage biotech company based in the Republic of Korea with labs and offices in the U.S. Founded in 2015, Bridge Biotherapeutics is engaged in the discovery and development of novel therapeutics for disease indications with high unmet medical needs including cancer, ulcerative colitis, and fibrotic diseases. The company's clinical pipeline includes 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."

Fibrosis • Gastroenterology • Gastrointestinal Disorder • Idiopathic Pulmonary Fibrosis • Immunology • Inflammatory Bowel Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Ulcerative Colitis • EGFR

Bridge Biotherapeutics to Present at the 2022 BIO International Convention (PRNewswire) - "Bridge Biotherapeutics Inc...is scheduled to give a company presentation on Thursday, June 16 at the 2022 BIO International Convention taking place in San Diego, California, between June 13 - 16, 2022....BBT-401, Pellino-1 inhibitor for ulcerative colitis."

Clinical • Inflammatory Bowel Disease • Ulcerative Colitis

BridgeBio “BBT-877 to start global phase 2 clinical trial at the earliest in June” [Google translation] (eDaily) - "An interim clinical presentation of BBT-401, an oral ulcerative colitis treatment, is also scheduled for the second half of this year. BBT-401 is the world's first drug under development as a pelino-1 inhibitor, and it has an anti-inflammatory mechanism by blocking the inflammatory signal via pelino-1, which is involved in the transduction of inflammatory signals in the body. Currently, phase 2a clinical trials are underway in five countries: Korea, the United States, New Zealand, Ukraine, and Poland."

Clinical data • Trial status • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: Bridge Biotherapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2022 ➔ Feb 2023 | Trial primary completion date: Feb 2022 ➔ Nov 2022

Enrollment closed • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Bridge Bio to start global clinical trials for new lung cancer and colitis treatment next year [Google translation] (Financial News) - "According to BridgeBio, BBT401 plans to complete its clinical trial in the first half of 2022 and enter a late-stage clinical trial in the second half of 2022."

New trial • Trial completion date • Inflammatory Bowel Disease • Ulcerative Colitis

Bridge Biotherapeutics Announces Initiation of the Phase I Clinical Trial for BBT-401 in China (PRNewswire) - "Bridge Biotherapeutics...announced that the first subject has been dosed in the China Phase I clinical trial of BBT-401, a small molecule inhibitor of Pellino-1, which is believed to play a significant role in inflammatory signaling pathways....The China Phase I clinical study of BBT-401, composed of both single and multiple ascending dose studies, evaluates the safety, tolerability, and pharmacokinetics data collected from 30 adult subjects with no significant health problems relevant to the drug candidate and the study."

Trial status • Inflammatory Bowel Disease • Ulcerative Colitis

Bridge Biotherapeutics to Expand Investment on R&D (Korea Biomedical Review) - "Bridge Bio’s R&D pipelines include BBT-401, a drug candidate for ulcerative colitis undergoing phase 2a clinical trial in five countries, including the U.S., Korea, and Eastern Europe. Its results are to be announced in the next half of the year."

P2a data • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis (clinicaltrials.gov) - P2; N=36; Recruiting; Sponsor: Bridge Biotherapeutics, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Bridge Biotherapeutics Integrates CDD Vault Collaborative Database Solution into Its R&D Platform to Harmonize Research and Drug Discovery Project Management (PRNewswire) - "Bridge Biotherapeutics, Inc...announced today that it had integrated CDD Vault into its internal collaboration workflow...Bridge Biotherapeutics has been focused on expanding its research and development pipeline in the areas of inflammation, pulmonology, and oncology while advancing its clinical pipelines such as BBT-401, a Pellino-1 inhibitor for ulcerative colitis (UC)...With multiple integrated research activities being carried out across different labs and geographies, there is an increasingly urgent need for a solution that can provide a way, in real-time, to share, manage, store and analyze large amounts of data in one place, all while being accommodating to scientific diagrams, chemical structures, biological data and more."

Licensing / partnership • Inflammatory Bowel Disease • Ulcerative Colitis

Bridge Biotherapeutics Announces the Initiation of Patient Dosing in the Proof of Clinical Principle Study for BBT-401, an Investigational Drug for Ulcerative Colitis (PRNewswire) - "Bridge Biotherapeutics...announced today the first patient dosing of BBT-401 at mid to high doses in its proof of clinical principle (PoCP) study to examine the drug's efficacy and safety in active ulcerative colitis (NCT04596293)...'Additionally, our goal is to disclose the interim data of the study in the first half of 2022'...In conjunction with the orally administered PoCP study, a proof of mechanism trial has been initiated in New Zealand, exploring the efficacy and safety of a rectal administration of BBT-401 in patients with active ulcerative colitis."

P2a data • Trial status • Inflammatory Bowel Disease • Ulcerative Colitis

Bridge Biotherapeutics begins clinical dosing of new ulcerative colitis drug (Korea Biomedical Review) - "Bridge Biotherapeutics...began administering BBT-401, an ulcerative colitis drug candidate, to investigate the mechanism of action of a new method in clinical trials in New Zealand...'We have initiated a new study to investigate the safety and efficacy of another way of administering BBT-401 along with the phase 2 clinical trials of high and medium dose of oral administration in ulcerative colitis patients'...The company expects to disclose the interim results of the study in the first half of 2022."

P2 data • Trial status • Inflammatory Bowel Disease • Ulcerative Colitis

Major management matters related to investment judgment of Bridge Biotherapeutics Co., Ltd.(Phase 2a clinical trial plan approval of Korean Food and Drug Administration for ulcerative colitis treatment BBT-401) [Google translation] (Maekyung Media Group) - "The clinical trial and product approval process may result in results that do not meet expectations, and there is a possibility that the company may change or abandon its commercialization plan accordingly...Ulcerative Colitis Therapeutics BBT-401 for the treatment sikyak Korea 2a clinical trials, the planning approval...the protocol of the Korean title to moderate to severe ulcerative colitis test subjects administered orally at BBT-401-1S Response to adaptive, randomized, double-blind, placebo-controlled clinical trials including the step of prolonged double-blinding."

Non-US regulatory • Inflammatory Bowel Disease • Ulcerative Colitis

[KOSDAQ] Bridge Biotherapeutics, a company specializing in developing NRDO-type new drugs [Google Translation] (Hankyung) - "Bridge Biotherapeutics is conducting a phase 2a clinical trial of BBT-401 in the United States. The recruitment of patients in the first dose group has been completed. We are preparing to proceed with high-dose clinical trials in the future...Next year, after securing the data for phase 2a clinical trials, the company plans to promote technology transfer, such as developing business in earnest."

Enrollment status • P2a data • Inflammatory Bowel Disease • Ulcerative Colitis

Bridgebio, a new drug for lung cancer, to begin domestic clinical trials within the year as early as Phase 1 and 2 [Google Translation] (Maekyung Media Group) - "Among the company's development pipelines,'BBT-401', a candidate for treating ulcerative colitis, which has the most advanced clinical stage, is also undergoing mid- and high-dose trials in phase 2a clinical trials in Korea, the United States, and Eastern Europe as early as the end of this year or early next year."

New P2 trial • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis (clinicaltrials.gov) - P2; N=36; Not yet recruiting; Sponsor: Bridge Biotherapeutics, Inc.

Clinical • New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of BBT-401-1S in Ulcerative Colitis (clinicaltrials.gov) - P2a; N=16; Terminated; Sponsor: Bridge Biotherapeutics, Inc.; Active, not recruiting ➔ Terminated; to carry out the rest of the study with new CRO and modified protocol as a multi-regional study.

Clinical • Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Bridge Biotherapeutics Announces Detailed Plans for the Phase 2a Study of BBT-401 (PRNewswire) - "Bridge Biotherapeutics...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....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....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."

P2a data • Preclinical • Trial initiation date • Inflammatory Bowel Disease • Ulcerative Colitis

Bridge Biotherapeutics Announces 2:1 Bonus Issue (PRNewswire) - "...BBT-401 (Pellino-1 inhibitor for ulcerative colitis)...will enter into the second cohort study in the Phase IIa trial...by the end of 2020 or early 2021."

Trial status • Inflammatory Bowel Disease • Ulcerative Colitis

Bridge Biotherapeutics becomes BaseLaunch's first Asia Pacific partner (PRNewswire) - "Bridge Biotherapeutics...and BaseLaunch, the Basel Area-based biotech venture accelerator and incubator, today announces that Bridge Biotherapeutics has become a partner in BaseLaunch Phase II."

Licensing / partnership • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of BBT-401-1S in Ulcerative Colitis (clinicaltrials.gov) - P2a; N=16; Active, not recruiting; Sponsor: Bridge Biotherapeutics, Inc.; Recruiting ➔ Active, not recruiting; N=48 ➔ 16; Trial completion date: Dec 2020 ➔ Jul 2020

Clinical • Enrollment change • Enrollment closed • Trial completion date • Gastroenterology • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis