Bridge Biotherapeutics said Tuesday that the Independent Data Monitoring Committee (IDMC) has recommended the company continue conducting phase 2 clinical trial of BBT-877, its candidate for treating idiopathic pulmonary fibrosis (IPF).

According to the company, the IDMC was held to review the safety and efficacy of BBT-877 based on interim data from the ongoing phase 2 trial in North America, Europe, and Asia and to discuss the continuation of the trial. The meeting discussed efficacy and safety data from 57 patients treated with BBT-877 as of Jan. 20.

Based on this data, collected without any early discontinuations, the committee recommended that BBT-877 continue into phase 2 as planned.

Accordingly, Bridge Biotherapeutics plans to accelerate clinical trials exploring the efficacy and safety of BBT-877, developed as a first-in-class autotaxin inhibitor. In addition, the safety and overall drug profile of BBT-877 in combination with nintedanib-pirfenidone, the standard of care for IPF, will be explored.

"The recommendation to continue clinical development is a testament to the overall competitiveness of the drug, including its safety profile," Bridge Biotherapeutics CEO Lee Jung-kue said. "We will do our best to accelerate the development of BBT-877 and expedite technology transfer by capitalizing on the global interest in autotaxin mechanisms in treating pulmonary fibrosis."

BBT-877 is a first-in-class drug candidate that selectively inhibits the novel target protein, autotaxin. Since the initiation of dosing in the first patient in April last year, the study has recruited 71 patients with idiopathic pulmonary fibrosis and is exploring the efficacy, safety, and pharmacokinetics of BBT-877 in about 60 percent of the targeted people.

It has been selected as a new project for Phase 2 of the first National New Drug Development Program in 2023 and is supported by the Korea Drug Development Fund (KDDF).

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