BBT-401 is under development as a treatment for ulcerative colitis.

  • About the drug candidate

    BBT-401 is a once-daily orally administered pellino-1 protein inhibitor, currently in Phase II clinical trials and is under development as a treatment for ulcerative colitis. BBT-401 is not absorbed systemically, rather its designed to activate only in the digestive tract - which was confirmed in both the pre-clinical studies and the Phase I clinical trial. Such localized distribution is expected to eliminate the side effects from systemic inhibition of inflammation by allowing selective suppression of inflammation in the large intestine (the site of the disease). The drug’s effect on inflammation and colonic mucosa regeneration was confirmed in ulcerative colitis-induced animal disease models

    The biological function of Pellino-1 proteins was identified by Korean researchers in 2006 and is known to play an important role in regulating the various proteins required for an inflammatory response. The Pellino-1 protein transmits external inflammatory signals to the cell nucleus, which is detected by receptors in immune cells. In abnormal chronic inflammatory conditions, BBT-401 binds with Pellino-1 to block the transmission of inflammatory signals, resulting in an anti-inflammatory effect.

    Additionally, Pellino-1 plays an important role in the transmission of inflammatory responses in microglia in patients with degenerative brain diseases, implying that Pellino-1 is a potential target protein for the treatment of various degenerative brain diseases.

    Upon the completion of the Phase IIa, low dose study(NCT03800420), which was the first-in-patient study for BBT-401, the drug formulation has been enhanced in terms of its drug delivery and distribution to the ileum and distant colon. The enhanced drug delivery and distribution profile was evaluated via the in vitro Simulator of the Human Intestinal Microbial Ecosystem (SHIME®) model. With the enhanced formulation, Bridge Biotherapeutics launched the proof of clinical principle (PoCP) study(NCT04596293) in order to assess the safety and efficacy profiles of BBT-401 ranging from mid to high doses. This multinational study includes 36 clinical sites located in five countries comprising the U.S., Republic of Korea, New Zealand, Poland and Ukraine.

    Bridge Biotherapeutics acquired the exclusive global license for BBT-401 from the Korea Research Institute of Chemical Technology (KRICT) and Sungkyungkwan University in October, 2015. In December 2018, Bridge Biotherapeutics licensed out the development and commercialization rights for the Asia region (22 countries) to Daewoong Pharmaceutical.

    Our research results were presented at the following conferences and can be downloaded by clicking the link down below.

    • Event
      Date of Presentation
    • Event

      Crohn’s & Colitis Congress 2019

      Date of Presentation

      2019년 02월 07일

  • Clinical studyinformation

  • Ask about the clinical studies

  • What is ulcerative colitis?

    Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that causes inflammation or ulceration in the mucous membrane or submucosa of the large intestine. UC is distinguished from Crohn’s disease (another IBD which shows sporadic occurrence in the entire small and large intestines), as characterized by lesions that begin in the rectum near the anus and continue inside the large intestine.

    Most ulcerative colitis patients experience loose feces with blood and mucus or diarrhea several times a day, and suffer from abdominal pain, dehydration, fever, vomiting and weight loss in severe cases. Symptoms not related to the large intestine include nodular erythema, necrotizing pyoderma, oral ulcers, oculopathy, arthritis and ankylosing spondylitis.

    Ulcerative colitis is usually a chronic disease with repeated cycles of symptoms and remissions. The symptoms worsen as the disease recurs, and 3-18% of all patients eventually develop colorectal cancer. Additionally, in cases of acute blunt colitis with severe symptoms, urgent surgery to remove the entire colon may be required within a few days, should there be no response to available treatments.

    Depending on symptom severity, 5-ASA drugs are commonly prescribed as a first line therapy, followed by steroids and biologics. As such, the treatment market is currently divided into three categories: 1) safe and affordable primary drugs with low efficacy, 2) short-term steroid treatments if 5-ASAs alone are not effective, and 3) expensive biologics with high efficacy. Therefore, the need for a novel, primary treatment with a high efficacy at an affordable price is very high.

    More information available on NHS UK