Bridge Biotherapeutics Receives FDA Authorization to Proceed with Phase 2 Study of BBT-877

• BBT-877 is intended to explore its treatment efficacy in idiopathic pulmonary fibrosis patients in a Phase II trial expected to start in 2022

SEONGNAM, South Korea, Aug. 16, 2022 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), 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. Further information is available at www.clinicaltrials.gov/show/NCT05483907.

• 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

About Bridge Biotherapeutics, Inc.

Bridge Biotherapeutics Inc., based in the Republic of Korea, US, and China, is a publicly-traded, clinical-stage biotech company founded in 2015. Bridge Biotherapeutics is engaged in the discovery and development of novel therapeutics, focusing on therapeutic areas with high unmet needs including ulcerative colitis, fibrotic diseases, and cancers. The company is developing BBT-401, a first-in-class Pellino-1 inhibitor for the treatment of ulcerative colitis, BBT-877, a novel autotaxin inhibitor for the treatment of fibrotic diseases including idiopathic pulmonary fibrosis (IPF), and BBT-176, a potent targeted cancer therapy for non-small cell lung cancer (NSCLC) with C797S triple EGFR mutations.

About Autotaxin

Autotaxin (ATX), a protein of approximately 900 amino acids discovered in the early 1990s, is an important enzyme for generating the lipid-signaling molecule, lysophosphatidic acid (LPA). Autotaxin's lysophospholipase D activity converts lysophosphatidylcholine (LPC) into LPA, which engages in signaling via LPA receptors. LPA signaling results in cell proliferation, migration, secretion of cytokines and chemokines, and reduction of cell apoptosis. Ultimately, autotaxin has a pathogenic role in processes of inflammation and fibrosis, making it an attractive drug target. BBT-877, an experimental autotaxin inhibitor, demonstrated LPA inhibition of up to 90 percent in multiple-ascending dose cohorts of the Phase 1 study.

About idiopathic pulmonary fibrosis (IPF)

IPF is a rare, debilitating and fatal lung disease which affects approximately 3 million people worldwide. Progression of IPF is variable and unpredictable, and over time the lung function of an IPF patient gradually and irreversibly declines.