Bridge Biotherapeutics said it presented the preclinical and phase 1 study results for BBT-401, a drug candidate for ulcerative colitis (UC) treatment, at the poster session of the Crohn's & Colitis Congress last Thursday.

BBT-401, found by Sungkyunkwan University and Korea Research Institute of Chemical Technology, is a gastrointestinal-tract restricted small molecule inhibitor of Pellino-1. Bridge Biotherapeutics and Daewoong Pharmaceutical have recently signed a license agreement to co-develop BBT-401.

“BBT-401, a potent first-in-class drug candidate as Pellino-1 inhibitor, demonstrated superior anti-UC efficacy compared to other therapies in the preclinical studies, which includes improved clinical symptoms and reduced gross and histopathology scores,” the company said. “Also, phase 1 clinical study data indicate that BBT-401 is safe and well tolerated in the healthy volunteers as the drug candidate has not been systemically exposed after oral administrations.”

The results strongly suggest that BBT-401 will exclusively act on damaged intestinal membranes of UC patients, which will lead to the development of an efficient UC therapeutics, it added.

The company began registering patients at three institutions for the phase 2 clinical trials of the drug in December. It plans to start the clinical trial from this month as it has recruited additional patients at seven other locations.

"It is such a great opportunity for us to present the preclinical and the phase 1 study results supporting the safety and tolerability of BBT-401 at the Congress, said Lee Gwang-hee, head of Translational Research at Bridge Biotherapeutics. “Our team aims to develop the drug candidate as the first-in-class drug for UC as fast as possible to bring this novel compound to patients as a new treatment option, proving strong anti-inflammatory efficacy in active UC patients.”