Bridge Biotherapeutics Receives US FDA Approval for Phase 2 Clinical Trial of Idiopathic Pulmonary Fibrosis Treatment Candidate 'BBT-877'

"Final Resolution of Potential Toxicity Issues"

[Asia Economy Reporter Lee Gwan-ju] Bridge Biotherapeutics announced on the 21st that it has received final approval notification from the U.S. Food and Drug Administration (FDA) to commence Phase 2 clinical trials for its idiopathic pulmonary fibrosis treatment candidate 'BBT-877.'

BBT-877 faced a crisis when its partner company returned the technology, citing potential toxicity concerns just before entering Phase 2 clinical trials in 2020. In response, Bridge Biotherapeutics conducted various experiments, including in-vivo Comet Assay, to comprehensively demonstrate safety, submitted the data to the FDA, and also filed an Investigational New Drug (IND) application for Phase 2 clinical trials.

The FDA concluded that the previously raised potential toxicity issues related to BBT-877 were resolved and, on the 20th (local time), provided final written approval for the commencement of Phase 2 clinical trials and subsequent development plans, the company explained. Bridge Biotherapeutics has completed contract procedures with the Contract Research Organization (CRO) and plans to activate the first clinical trial sites and begin patient recruitment in the third quarter.

Lee Jung-kyu, CEO of Bridge Biotherapeutics, stated, “We are honored to have received clear resolution from the FDA regarding the long-standing potential toxicity issue of BBT-877 in the market, along with approval to enter Phase 2 clinical trials without any changes or delays to our planned development strategy.” He added, “With the recent rise in global expectations for new drug development due to COVID-19 infections and population aging, we will strive to quickly deliver innovative new drug development results in the field of pulmonary fibrosis.”

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