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

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 Ends Rectally Administered Study of BBT-401 in Patients with Active Ulcerative Colitis (NCT04478825) (BridgeBio) - "Bridge Biotherapeutics announced the decision to end its investigational study of their rectally administered formulation of BBT-401, a pellino-1 inhibitor for the treatment of Ulcerative Colitis. For the present, the company will focus its efforts towards its commitment on the development of their further clinically advanced, orally administered formulation...The company may revisit the rectal administration of BBT-401 after the completion of the multi-national Phase 2a study of BBT-401."

Discontinued • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis (clinicaltrials.gov) - P1; N=2; Terminated; Sponsor: Bridge Biotherapeutics, Inc.; Trial completion date: Jun 2022 ➔ Aug 2021; Recruiting ➔ Terminated; Trial primary completion date: May 2022 ➔ Aug 2021; Internal Company Decision

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

Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis (clinicaltrials.gov) - P1; N=6; Recruiting; Sponsor: Bridge Biotherapeutics, Inc.; Trial completion date: Jun 2021 ➔ Jun 2022; Trial primary completion date: Apr 2021 ➔ May 2022

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

Bridge Biotherapeutics Announces the Initiation of the Proof of Mechanism Study for BBT-401 in Patients with Ulcerative Colitis; Rectal Delivery of Drug to Target Site (PRNewswire) - "Bridge Biotherapeutics (KQ288330) today announced the first patient dosing of BBT-401 in its open label, proof of mechanism study to examine the drug's efficacy and safety in active ulcerative colitis when delivered rectally to the colon (NCT04478825)...The interim data of the medium to high dose study is expected to be disclosed in the first half of 2022."

P1 data • Trial status • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis (clinicaltrials.gov) - P1; N=6; Recruiting; Sponsor: Bridge Biotherapeutics, Inc.; Not yet recruiting ➔ Recruiting

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

Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis (clinicaltrials.gov) - P1; N=6; Not yet recruiting; Sponsor: Bridge Biotherapeutics, Inc.; Phase classification: P1/2 ➔ P1

Clinical • Phase classification • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis (clinicaltrials.gov) - P2; N=6; Not yet recruiting; Sponsor: Bridge Biotherapeutics, Inc.

Clinical • New P1/2 trial • New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis