Merck Submits IND Application in China for Sotatercept, an ACVR2A-Fc Fusion Protein Acquired for $11.5 Billion, for Pulmonary Arterial Hypertension

On June 7, the CDE website showed that MSD's ACVR2A-Fc fusion protein sotatercept was submitted for clinical trial for the first time.

Sotatercept is an ACVR2A-Fc fusion protein composed of the extracellular domain of human Activin receptor IIA fused with the Fc domain of IgG1. It can bind and trap TGF-β family ligands (TGF-β ligand trap), thereby restoring the balance of the BMPR-2 signaling pathway. Since the imbalance of BMPR-II signaling is a pathogenic factor in pulmonary arterial hypertension (PAH), sotatercept achieves its therapeutic purpose of alleviating inflammation in PAH patients through this mechanism.

In September 2021, Merck & Co., Inc. (MSD) reached an $11.5 billion acquisition agreement with Acceleron, gaining access to the newly approved anemia drug Reblozyl and the investigational drug sotatercept.

In October 2022, the Phase III STELLAR study of sotatercept for PAH achieved positive results, meeting the primary endpoint and multiple secondary endpoints. Notably, this drug is also the first PAH drug to receive Breakthrough Therapy designation through the FDA's Breakthrough Therapy Registration Pathway since its establishment in 2012.

PAH is a rare, progressive, and life-threatening vascular disease characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. It not only places severe strain on the heart but also leads to limited physical activity, heart failure, and reduced life expectancy. Despite standard treatments, many patients experience rapid disease progression, with a 5-year mortality rate of approximately 43%.

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