Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, South Korea, announced that the company presented the preclinical and the Phase I study results for BBT-401, a drug candidate for Ulcerative Colitis (UC) treatment, at the poster session of the Crohn's & Colitis Congress held in Las Vegas, NV from February 7th to 9th.
The congress, which is based on a partnership between the Crohn's & Colitis Foundation and the American Gastroenterological Association (AGA), brings healthcare professionals, academics and the pharma/bio industry across the globe for better Inflammatory Bowl Diseases (IBD) treatments and patient care.
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 histo-pathology scores.
In addition, the Phase I 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. It strongly suggests that BBT-401 will exclusively act on damaged intestinal membranes of UC patients, which will lead to the development of an efficient UC therapeutics.
The drug candidate is currently under the Phase 2 clinical study for UC patients in the U.S. The first cohort is open for enrollment with a targeted completion by the end of the year. The dosing regimens of the second and the third cohorts will be determined based on the results of preceding cohorts.
"It is such a great opportunity for us to present the preclinical and the Phase I study results supporting the safety and tolerability of BBT-401 at the congress. 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 new treatment option, proving strong anti-inflammatory efficacy in active UC patients," stated Dr. Gwanghee Lee, the Head of Translational Research at Bridge Biotherapeutics.
BBT-401, discovered by SKKU (Sungkyunkwan University) and KRICT (Korea Research Institute of Chemical Technology) is a GI-tract restricted small molecule inhibitor of Pellino-1. Bridge Biotherapeutics and Daewoong Pharmaceutical Co., Ltd., a Korean pharmaceutical giant, have recently signed a license agreement for co-development of BBT-401.