BridgeBio, Phase 2 Clinical Trial for Idiopathic Pulmonary Fibrosis Treatment Becomes Visible

BBT-877, Data Submitted to FDA to Prove Safety
"IND Already Approved... Clinical Trial to Start in Second Half of the Year"

[Asia Economy Reporter Lee Chun-hee] Bridge Biotherapeutics is making visible progress toward entering Phase 2 clinical trials for its idiopathic pulmonary fibrosis (IPF) treatment candidate, ‘BBT-877.’

On the 22nd, Bridge Biotherapeutics announced that it submitted related data to the U.S. Food and Drug Administration (FDA) to initiate Phase 2 clinical trials for BBT-877 and has begun discussions.

BBT-877 is an oral autotaxin (ATX) inhibitor developed for the treatment of IPF. It is being developed with the goal of becoming the first-in-class in its category. Last year, the clinical trial of ‘GLPG1690’ by Belgium’s Galapagos NV, which was leading the field with its Phase 3 trial, was suddenly halted, and BBT-877 is now in fierce competition with the U.S.-based Blade Therapeutics’ ‘BLD-0409.’

However, after completing Phase 1 clinical trials, BBT-877 was licensed out to Boehringer Ingelheim, but the rights were returned due to potential toxicity concerns raised during Boehringer’s non-clinical testing. Bridge Biotherapeutics maintains that this was a ‘false positive’ caused by cell death mechanisms from high-dose drug treatment.

During a Type C meeting with the FDA last year to enter Phase 2 trials, additional data such as transmission electron microscopy (TEM) results from in vivo animal studies were requested regarding safety. Based on this, additional experiments were conducted to confirm the drug’s safety, and positive data and evidence for entering Phase 2 were secured and finally submitted to the FDA last month.

The company stated that since the Investigational New Drug (IND) application has already been approved, it plans to start multinational Phase 2 clinical trials in the second half of this year, based on the FDA’s expected response as early as next month. To this end, it has contracted with a global contract research organization (CRO) experienced in conducting multinational clinical trials in the IPF field.

Lee Jung-kyu, CEO of Bridge Biotherapeutics, said, “Despite fierce domestic and international competition in the IPF drug development field, we were able to reconfirm the competitiveness of BBT-877 based on various experimental data,” adding, “We will strive to quickly enter clinical stages involving patients and achieve visible results.”

This content was produced with the assistance of AI translation services.