Bridge Biotherapeutics Announces Initiation of the Phase I Clinical Trial for BBT-401 in China

• China Phase I study of BBT-401 had its first subject dosed in Chengdu, China
• The company seeks to accelerate its business development activities with Daewoong, their partner for the development and commercialization of BBT-401 in 22 Asian countries

SEONGNAM, South Korea and CHENGDU, China, Oct. 19, 2021 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a clinical-stage biotech company focused on developing novel drugs for inflammation, fibrosis and oncology, announced that the first subject has been dosed in the China Phase I clinical trial of BBT-401, a small molecule inhibitor of Pellino-1, which is believed to play a significant role in inflammatory signaling pathways.

For the development of BBT-401, Bridge Biotherapeutics received Investigational New Drug (IND) clearance from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) in December 2019 and activated the Chinese clinical study after improving the drug formulation with enhanced drug delivery to the ileum and colon.

The China Phase I clinical study of BBT-401, composed of both single and multiple ascending dose studies, evaluates the safety, tolerability, and pharmacokinetics data collected from 30 adult subjects with no significant health problems relevant to the drug candidate and the study. The Fifth People's Hospital of Chengdu has been selected as the clinical trial site for the study.

"In addition to the multinational Phase IIa study being conducted in 5 countries worldwide, the initiation of the Chinese Phase I clinical study for BBT-401 will bring us closer towards providing an innovative treatment option to patients suffering from ulcerative colitis," and "We will continue to focus on developing the novel drug to address the huge unmet medical needs in ulcerative colitis, whose prevalence in the Asian region has been steadily rising," stated James Lee, CEO of Bridge Biotherapeutics.

In December 2018, Bridge Biotherapeutics entered into a strategic alliance agreement with Daewoong for the development and commercialization of BBT-401 in 22 countries across Asia, including China. With the launch of the Chinese clinical study, both companies are expected to further accelerate business development activities in the Asian territories where there is a heightened demand for an effective therapy.

"Given the increasing prevalence of ulcerative colitis in China, we are highly encouraged to initiate the Phase I clinical study of BBT-401 in China, one of the biggest markets in the world" and "Daewoong Pharmaceutical will make the best effort to develop the first-in-class therapeutics through accelerating our partnership with Bridge," Seng-Ho Jeon, CEO of Daewoong Pharmaceutical said.

BBT-401, an investigational drug with the potential to exhibit treatment efficacy in inflammatory diseases such as ulcerative colitis, is a GI-tract restricted small molecule Pellino-1 inhibitor. Pellino proteins serve as scaffold proteins that bind to proteins in inflammatory signaling pathways, including IRAK4, MyD88 and to RIPK1 in various physio-pathological conditions. The drug candidate is currently in the multinational Phase 2a, mid to high dose cohort study in the US, New Zealand, Republic of Korea, Poland and Ukraine.

About Bridge Biotherapeutics, Inc.

Bridge Biotherapeutics Inc., based in the Republic of Korea, US, and China, is a publicly-traded clinical-stage biotech company founded in 2015. Bridge Biotherapeutics is engaged in the discovery and development of novel therapeutics, focusing on therapeutic areas with high unmet needs such as ulcerative colitis, fibrotic diseases, and cancers. The company is developing BBT-401, a first-in-class Pellino-1 inhibitor for the treatment of ulcerative colitis, BBT-877, a novel autotaxin inhibitor for the treatment of fibrotic diseases including idiopathic pulmonary fibrosis (IPF), and BBT-176, a potent targeted cancer therapy for non-small cell lung cancer (NSCLC) with C797S triple EGFR mutations.

About Daewoong Pharmaceutical Co., Ltd.

Established in 1945, Daewoong Pharmaceutical Co., Ltd. is a leading South Korean pharmaceutical company that develops, manufactures, and commercializes pharmaceuticals for both domestic and international markets. With its strong and competent in-house R&D and qualified manufacturing facilities, Daewoong provides a total healthcare solution to customers across the globe. Aiming to become a global healthcare company, Daewoong has broadened international operations by establishing branch offices and research centers throughout Asia and the United States. Also Daewoong has expanded strategic partnerships in more than 100 countries worldwide.

SOURCE Bridge Biotherapeutics, Inc.