BridgeBio "Idiopathic Pulmonary Fibrosis New Drug Candidate Recommended to Continue Phase 2"

IDMC "BBT-877, No Safety Concerns Found in Interim Review of Phase 2 Data"

Bridge Biotherapeutics announced on the 11th that it has received a recommendation from the Independent Data Monitoring Committee (IDMC) to continue the Phase 2 clinical trial of 'BBT-877,' a drug candidate for the treatment of idiopathic pulmonary fibrosis.

Bridge Biotherapeutics CI. [Image provided by Bridge Biotherapeutics]

This recommendation from the IDMC was made based on an interim data review of the ongoing multinational Phase 2 clinical trial of BBT-877 being conducted in North America, Europe, and Asia. After reviewing the efficacy and safety data at the 4-week mark of BBT-877 administration in 20 patients with idiopathic pulmonary fibrosis enrolled in the trial, the IDMC found no safety concerns regarding the drug and recommended continuing the clinical trial as originally planned.

The IDMC is a committee composed of experts who independently monitor the efficacy and safety of a drug during the clinical trial. It operates to ensure safety and scientific validity in randomized, double-blind clinical trials. The IDMC advises the clinical sponsor on whether to continue the trial, delay patient recruitment, amend the clinical trial protocol, or terminate the trial early.

Idiopathic pulmonary fibrosis is a fatal disease known to cause death in more than 50% of patients within 3 to 5 years without appropriate treatment. Considering the limited use of existing standard treatments due to side effects and the imminent patent expiration, Bridge Biotherapeutics explains that the market demand for new idiopathic pulmonary fibrosis treatments is increasing.

Bridge Biotherapeutics received approval for the Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) in July last year to initiate clinical trials of BBT-877 in patients with idiopathic pulmonary fibrosis. In April of this year, the company began dosing the first trial participant and has since recruited about 40 participants.

Meanwhile, BBT-877 is a first-in-class drug candidate that selectively inhibits autotaxin, a novel target protein. It was selected as a new supported project in the 'Phase 2 clinical trial' category of the 2023 National New Drug Development Project and is receiving support from the National New Drug Development Project Group.

Lee Jung-kyu, CEO of Bridge Biotherapeutics, stated, "In the development of pulmonary fibrosis treatments, where long-term combination therapy with other drugs may be necessary, the safety profile of the drug is a very important consideration. Receiving a positive signal from the IDMC regarding the development of BBT-877 is a meaningful advancement confirming the initial safety of BBT-877 as an autotaxin inhibitor in patients with idiopathic pulmonary fibrosis." He added, "We will accelerate clinical development to promptly introduce innovative treatment options in the field of pulmonary fibrosis, a refractory disease."

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