BridgeBio Completes Patient Enrollment for Phase 2 Clinical Trial of Idiopathic Pulmonary Fibrosis Treatment
Bridge Biotherapeutics announced on the 30th that it has completed the enrollment of the targeted 120 patients in the Phase 2 clinical trial of BBT-877, a candidate drug under development for idiopathic pulmonary fibrosis. Considering the possibility of additional enrollment of patients currently in the screening phase, it is expected that more than 125 patients will ultimately participate.
This Phase 2 clinical trial is being conducted at over 50 institutions in South Korea, the United States, Australia, Poland, and Israel. A total of 120 patients will receive the investigational drug or placebo for 24 weeks to evaluate the drug’s efficacy, safety, and tolerability. Taking into account the dosing and follow-up schedule of the last patient, the results are planned to be announced in the first half of next year.
In particular, considering the severity of the disease and the safety of elderly trial subjects, the frequency of expert clinical trial data review and consultation through an independent data monitoring committee (IDMC) has been increased. So far, three IDMC meetings have been held, recommending the continuation of the clinical trial as planned. Additional IDMC meetings are scheduled to be held in the second half of this year.
Professor Song Jin-woo of the Department of Pulmonology at Seoul Asan Medical Center said, “In idiopathic pulmonary fibrosis, which is considered a rare disease, participation in clinical trials is regarded as a treatment option, reflecting the high demand for new therapies. The clinical trial of BBT-877 will serve as a stepping stone for new drug development that overcomes the difficulties in existing idiopathic pulmonary fibrosis treatments and suggests the possibility of lung function recovery for patients.”
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Lee Jung-kyu, CEO of Bridge Biotherapeutics, also said, “We are pleased to have completed the patient enrollment process early and to be able to accelerate the development of BBT-877. We will do our best to secure successful clinical results and work harder to promptly showcase global technology transfer achievements.”
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