Bridge Biotherapeutics said Friday that it has completed phase-1 clinical trials for BBT-401, an investigational drug for ulcerative colitis, in the U.S.
|Bridge Biotherapeutics CEO Lee Jung-kue (right) and KRICT President Kim Sung-soo hold a plaque celebrating the completion of the phase-1 clinical trial on BBT-401 at the KRICT building in Daejeon on Thursday.|
Like Crohn’s disease, ulcerative colitis is a common inflammatory bowel disease. It is a recurrent inflammatory disease with multiple ulcers in the mucosa of the colon.
BBT-401 is a first-in-class candidate jointly developed by Korea Research Institute of Chemical Technology (KRICT) and Professor Park Seok-hee’s team at Sungkyunkwan University. The substance is the first Pelino-1 inhibitor to control the function of the protein “Pellino-1,” which is involved in the immune function of the human body.
The company conducted the phase-1 trials at an institution in Lincoln, Nebraska, after receiving Investigational New Drug (IND) approval from the U.S. Food and Drug Administration earlier this year.
The study tested the drug in 80 healthy adults aged 19 or more for six months. As the trial ended without any serious adverse event, the company can move on to a phase-2 test to confirm the safety, tolerability and pharmacokinetic properties of the drug.
The company aims to begin the phase-2 study within this year.
Bridge Biotherapeutics CEO Lee Jung-kue said, “Based on the phase-1 clinical trial, we will do our best to finish the remaining clinical and development procedures so that we can accelerate the development of an innovative drug.”
Bride Biotherapeutics and the KRICT celebrated the completion of BBT-401’s successful phase-1 test at the KRICT building in Daejeon on Thursday.