Bridge Biotherapeutics Receives FDA Authorization to Proceed with Phase 2 Study of BBT-877
Bridge Biotherapeutics, a South Korean clinical-stage biotechnology company developing novel drugs for cancer, fibrosis and inflammation, announced it has received notice from the U.S. Food and Drug Administration (FDA) that it may proceed with a Phase 2 clinical study of BBT-877, an autotaxin inhibitor to treat patients with idiopathic pulmonary fibrosis (IPF). (US IND Number: IND 140199, NCT identifier: NCT05483907).
Following a Type C meeting for proceeding development of BBT-877 with the FDA in June 2021, the company submitted non-clinical data inclusive of in vivo comet assays with transmission electron microscopy (TEM) evaluation, and the protocol to fully support the safety of clinical studies in IPF patient participants. The U.S. FDA finally approved the final protocol, and confirmed the advancement of Phase 2 clinical study of BBT-877.
“We’re excited to continue the clinical development of BBT-877 in order to address unmet medical needs of IPF,” said James Lee, founder and CEO of Bridge Biotherapeutics. “With this approval, the company remains focused on developing novel treatment options for multiple fibrotic diseases, including IPF.”
Bridge plans to initiate the 24-week Phase 2 clinical study later this year. The multi-country study will include approximately 50 clinical sites in North America, Asia, and Europe.
- STUDY TITLE: A Phase 2, Randomized, Double-blind, Placebo-controlled, 24-Week Study to Evaluate the Efficacy, Safety, and Tolerability of BBT-877, as mono- or add-on therapy, in Patients with Idiopathic Pulmonary Fibrosis (IPF)
- STUDY DESIGN: Placebo-controlled and double-blind in North America, Asia, and Europe
- TEST PRODUCT: BBT-877 100 mg capsules, or placebo capsules, 2 capsules taken orally twice a day for six months
- PRIMARY OUTCOME MEASURES: Change from baseline in FVC (in mL) compared to placebo at Week 24 stratified by presence/absence of add-on therapy