The First Pellino-1 Inhibitor BBT-401 Confirms Its Safety and Tolerability from the Phase I Study

SEONGNAM, South Korea, Nov. 12, 2018 /PRNewswire/ — Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, South Korea, announced that BBT-401, the first anti-Pellino-1 compound currently under development for ulcerative colitis (UC) treatment, proved its safety and tolerability from phase I study.

BBT-401, a GI-tract restricted small molecule inhibitor of Pellino-1, was proved to be well tolerated and safe from Phase 1 Study, which is a randomized, double-blind study with 80 healthy volunteers. The most common adverse events were mild and recoverable diarrhea and mild headache. In addition, the PK data 1 demonstrated its key feature of no or minimal systemic exposure.

Bridge Biotherapeutics plans to initiate Phase II study in US within this year with patients with active UC diseases to see safety and efficacy at patients.

BBT-401 was discovered by SKKU (Sungkyunkwan University) and KRICT (Korea Research Institute of Chemical Technology) and was licensed the exclusive worldwide right to Bridge Biotherapeutics in 2015.

  • Product: BBT-401
  • Business: Inflammatory Disease
  • Molecular target: Pellino-1
  • Description: Oral small molecule inhibitor of Pellino-1
  • Indication: Ulcerative Colitis
  • Primary Endpoint: To assess the safety and tolerability of single and multiple ascending oral doses of BBT-401-1S in healthy adult subjects
  • Status: Phase I data
  • Milestone: Expected to begin Phase II study in December 2018

For more information

1. Bridge Biotherapeutics, Inc.

Bridge Biotherapeutics is a virtually-operated, venture-backed clinical stage biotech engaged in the development of novel therapeutics in the therapeutic areas of high unmet needs such as ulcerative colitis, fibrotic diseases and cancers.  Following its first compound BBT-401, BBT-877, a potent and selective Autotaxin (ENPP) inhibitor is being developed potentially for the treatment of various fibrotic diseases such as idiopathic pulmonary fibrosis (IPF) and non-alcoholic steatohepatitis (NASH). Bridge Biotherapeutics is a JLABS tenant company at JLABS@TMC, Houston, TX.

2. About Pellino Proteins

Pellino proteins are a family of E3 ubiquitin ligases which are highly conserved across species in mammal. Pellinos also serve as scaffold proteins that bind to proteins in inflammatory signaling pathways, including IRAK4, MyD88 (myeloid differentiation primary response gene 88) and to RIPK1 in various physio-pathological conditions.

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Source: Bridge Biotherapeutics, Inc.