Bridge Biotherapeutics announced on the 19th local time that it started administering phase 1 clinical trials in China for adult subjects of ‘BBT-401’, a candidate for the treatment of ulcerative colitis.
In December 2019, Bridge Biotherapeutics plans to conduct a phase 1 clinical trial of BBT-401 from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. After receiving approval for Investigational New Drug (IND), local clinical trials began in earnest after undergoing some revision procedures according to the formulation improvement process.
The phase 1 clinical trial conducted in China will evaluate the safety, tolerability, and pharmacokinetic data of the drug by conducting single and repeated dose escalation trials on 30 adult volunteers with no specific health findings. The clinical trial will be conducted at the 5th People’s Hospital in Chengdu.
According to the company, BBT-401, which is being developed as a treatment for ulcerative colitis as a candidate in the pelino-1 inhibitor family, exhibits a mechanism of inhibiting inflammation by inhibiting pelino-1 protein involved in various inflammatory signal transduction, and is administered orally. Because it acts locally in the gastrointestinal tract, it prevents side effects due to systemic exposure of the drug and shows drug safety. In particular, in this Chinese clinical trial, an improved formulation with an increased drug delivery rate to the end of the large intestine, a key affected area, is used after the completion of the phase 2 low-dose group trial of BBT-401 for active ulcerative colitis patients.
With the full-fledged clinical trial of BBT-401 in China as an opportunity, Bridge Biotherapeutics plans to further strengthen its cooperative system with its partner Daewoong Pharmaceutical, spurring its business development in Asia. Daewoong Pharmaceutical has obtained licenses and business rights for BBT-401 in 22 Asian regions, including China, Japan and Korea, through a joint development and technology transfer contract signed with Bridge Biotherapeutics in 2018.
Bridge Biotherapeutics CEO Lee Jeong-gyu said, “It is very meaningful to start Phase 1 clinical trials in China following the multinational phase 2 mid- and high-dose group trials that are currently underway in five countries including the US and Korea.” “As ulcerative colitis is easy to recur and requires a lifetime of treatment, we will speed up the development of new treatment options that are safe, effective and convenient to the global clinical scene,” he said.
Daewoong Pharmaceutical CEO Jeon Seung-ho said, “The number of ulcerative colitis patients is rapidly increasing in Asia, and it is very encouraging to start clinical trials in China, where the global pharmaceutical market is large.” “Daewoong Pharmaceutical and Bridge Bio will do its best to develop innovative new drugs by further solidifying the clinical and business development collaboration system.”
