BMS Receives Chinese Clinical Approval for Next-Generation LPA1 Antagonist BMS-986278-01 in Idiopathic Pulmonary Fibrosis

Text by |Pharma Insights

The latest announcement on the official website of the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA) indicates that two clinical trials for BMS-986278-01 tablets, a Class 1 new drug submitted by Bristol-Myers Squibb Company (BMS), have been approved in China for the indication of idiopathic pulmonary fibrosis. Based on publicly available information, it is speculated that this may be BMS-986278, a lysophosphatidic acid 1 (LPA1) receptor antagonist in BMS's pipeline, which is currently in global Phase II clinical trials.Development phase.

Image source: Screenshot from the CDE official website

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, and fatal fibrotic lung disease. Due to its insidious early symptoms, diagnosis typically occurs at moderate-to-advanced stages. With a mortality rate higher than that of most cancers, it is often referred to as "the cancer that isn't cancer." Although scientific understanding of the pathological mechanisms of fibrosis continues to deepen, effective therapies to reverse the fibrotic process remain elusive, and current treatment options are limited.

Research has shown that bioactive lysophosphatidic acids (LPA) and the LPA1 receptor are associated with the etiology and pathogenesis of IPF; consequently, the industry has identified LPA1 as a promising therapeutic target for IPF and other fibrotic diseases.

BMS-986278 is a novel next-generation LPA1 antagonist being developed by Bristol-Myers Squibb Company, intended for the treatment of pulmonary fibrosis. It is currently in Phase II clinical trials globally.

Image source: Screenshot from the official website of Bristol-Myers Squibb Company.

According to a study published in 2019, BMS-986278 is a potent and complete antagonist of LPA action on multiple LPA1-mediated signaling pathways in cells heterologously expressing human LPA1 and in primary human lung fibroblasts. In in vivo experiments, it inhibited LPA-stimulated histamine release in mice and exhibited anti-fibrotic activity. The article states that BMS-986278 represents a novel and promising LPA1 antagonist for the treatment of various fibrotic diseases.

A search of the ClinicalTrials.gov website reveals that at least six studies have been registered for BMS-986278. Among these, two trials in healthy subjects have been completed, and one Phase I clinical study evaluating monotherapy and combination therapy for idiopathic pulmonary fibrosis has also been completed.

With the clinical trial approval of BMS-986278-01 tablets in China, clinical development is expected to advance in the country. We look forward to this investigational drug bringing new treatment options to patients with pulmonary fibrosis as soon as possible.

References:

[1] Center for Drug Evaluation, National Medical Products Administration (CDE). Retrieved October 15, 2021, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2] Bristol-Myers Squibb Official Website. Retrieved Oct 15, 2021, from https://www.bms.com/researchers-and-partners/in-the-pipeline.html

[3]LPA1 antagonist BMS-986278 for idiopathic pulmonary fibrosis: Preclinical pharmacological in vitro and in vivo evaluation。from https://erj.ersjournals.com/content/54/suppl_63/PA5383?utm_source=TrendMD&utm_medium=cpc&utm_campaign=_European_Respiratory_Journal_TrendMD_1

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