South Korea based clinical stage biotech firm, Bridge Biotherapeutics Inc, has announced that the firm has been successful in activating clinical trial sites for Phase 2 study of a potential drug candidate for Ulcerative Colitis (UC) treatment, called BBT-401.
Apparently, this Phase 2 clinical study is a double blind, randomized, multi center, placebo controlled study to evaluate the safety and efficacy of BBT-401 in groups of patients with active UC. The change, at Week 8, from baseline in total Mayo Score would be the primary endpoint of the study. Three study sites located in North Carolina, Maryland and California have been activated and the enrollment of patient participants is currently underway, the firm confirmed.
Bridge Biotherapeutics estimates that by early next year seven study sites would be additionally initiated, and the dosing as well as clinical data analysis for the first out of three cohorts would be confirmed by second half of 2019. For the second and the third cohorts, dose escalation would supposedly be determined on the basis of the results of previous cohorts.
Bridge Biotherapeutics’ Head of Translational Research, Dr. Gwang-hee Lee, said in a statement that the company has initiated the Phase 2 study after the success of the first-in-human study. Team Bridge would continue its commitment to develop beneficial treatments for patients with UC and to achieve that goal, the site activation is a crucial stepping stone for the Phase 2 study, Lee mentioned.
Discovered by Korea Research Institute of Chemical Technology (KRICT) and Sungkyunkwan University (SKKU), BBT-401 is a small molecule inhibitor of Pellino-1, that is GI-tract restricted. The drug candidate was evidently proven to be safe and well tolerated in humans as shown in the drug’s Phase I study.
Purportedly, Korean pharmaceutical giant Daewoong Pharmaceutical Co., Ltd., along with Bridge Biotherapeutics has inked a license agreement recently, for the co-development of BBT-401 in the Asian countries.
