- The independent data monitoring committee (IDMC) recommended the continuation of the BBT-877 Phase 2a trial based on the initial clinical data from the first 20 participants dosed with the investigational product
- No safety concerns were raised based on the evaluation of the data presented at the IDMC meeting
SEONGNAM, South Korea and CAMBRIDGE, Mass., Oct. 26, 2023 /PRNewswire/ — Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company developing novel drugs for fibrosis and cancers, announced that the Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 2a trial (NCT05483907) evaluating the efficacy, safety, and tolerability of BBT-877 in patients with idiopathic pulmonary fibrosis (IPF).
According to IDMC’s comprehensive assessment on the clinical data from the first 20 IPF patients dosed with BBT-877 or matching placebo for four weeks, the ongoing Phase 2a trial of BBT-877 will continue without any changes to the current study plans. Also, no serious treatment-emergent adverse events (TEAEs) were reported from the 20 patients enrolled in the study.
"We are highly encouraged with the positive review and recommendation from the first IDMC meeting, which will mark a significant step forward for our strong commitment to developing novel drugs for IPF patients," said James Lee, founder and CEO of Bridge Biotherapeutics. "Thanks to the guidance from IDMC members, we will continue to advance the multinational clinical development of BBT-877, which is actively being conducted in countries across North America, Europe, and the Asia Pacific region."
BBT-877, an experimental Autotaxin (ATX) inhibitor, demonstrated its ability to inhibit lysophosphatidic acid (LPA) production by up to 90 percent in the first-in-human study. LPA is known to bind to cell receptors and induce various physiological activities, such as neovascularization, sclerosis, tumorigenesis, and tumor metastasis, leading to the development of various fibrotic diseases, including IPF. In April 2023, the company announced the dosing of the first patient in the Phase 2a trial of BBT-877. Over the past six months, approximately 40 patients have been enrolled in the study. The study aims to recruit approximately 120 patients who have or have not been treated with current standard treatments- pirfenidone or nintedanib.
It is estimated that more than 58,000 new cases of IPF are diagnosed in the U.S. alone each year, and as many as 207,000 people are affected by the disease in the U.S. With a median survival of 3 years, IPF affects up to 3 million people worldwide, with increasing incidence in older population.
About Bridge Biotherapeutics, Inc.
Bridge Biotherapeutics Inc., based in the Republic of Korea and the U.S., 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 fibrotic diseases and cancers. The company is developing BBT-877, a novel autotaxin inhibitor for the treatment of fibrotic diseases including idiopathic pulmonary fibrosis (IPF), and BBT-207, a potent targeted cancer therapy for non-small cell lung cancer (NSCLC) with EGFR C797S mutations. Learn more at https://www.bridgebiorx.com/en/.
About BBT-877
BBT-877 is an orally administered autotaxin enzyme inhibitor which is under development as a treatment for various fibrotic diseases such as idiopathic pulmonary fibrosis (IPF). During the Phase 1 Clinical trial, the experimental autotaxin inhibitor demonstrated lysophosphatidic acid (LPA) inhibition of up to 90 percent in multiple-ascending dose cohorts. Since April 2023, clinical sites located in North America, Europe and the Asia Pacific region have been recruiting patient participants for the Phase 2a clinical trial of BBT-877.
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.
About idiopathic pulmonary fibrosis (IPF)
IPF is a rare, debilitating, and fatal lung disease which affects approximately 3 million people worldwide. The progression of IPF is variable and unpredictable. Over time, the lung function of an IPF patient gradually and irreversibly declines.