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Big news! The first antibody drug for Pulmonary Arterial Hypertension has been approved for clinical trials in China

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Recently, GMA301 as is named so far, a recombinant monoclonal antibody drug targeting to human endothelin receptor A, developed by Gmax Biopharm LLC, has been approved for clinical trials in China for the treatment of Pulmonary Arterial Hypertension (PAH) since October 2019.

 


PAH is a malignant disease, with poor prognosis and high mortality, and is treated as a cancer in cardiovascular diseases. The main pathology of PAH is pulmonary artery stenosis leading to progressively high pulmonary vascular resistance and high pulmonary arterial pressure, usually accompanied by irreversible pulmonary vascular remodeling and right ventricular hypertrophy. The disease eventually leads to heart failure and death.

 


Pulmonary hypertension can exist independently as a disease without any causes found, known as idiopathic or hereditary pulmonary hypertension. It can be caused by other diseases, such as congenital heart disease, rheumatic immune disease (such as scleroderma, lupus erythematosus, etc.), liver cirrhosis, sleep breathing disorder, pulmonary thromboembolism, chronic obstructive pulmonary disease, AIDS and other diseases etc,. Patients usually insidiously onset, and their early symptoms are not obvious, thus resulting in difficulty in diagnosis, including missed diagnosis and misdiagnosis, seriously affecting the quality of life and life cycle of patients.


Drug therapy is the first choice for the treatment of pulmonary hypertension. GMA301 is the first antibody drug targeting to endothelin receptor A for the treatment of pulmonary arterial hypertension, and is developed by GMAX on its independently constructed g-protein-coupled receptor (GPCR) antibody technology platform. The drug has been completed its phase Ia clinical trial in Australia and a multi-center phase Ib clinical trial will be carried out in China and the United States shortly.

 

GMA301 schematic diagram

 

GMA301 action mechanism diagram


Preclinical studies, in cynomolgus monkey animal models, have shown that GMA301 can significantly reduce pulmonary artery systolic pressure, significantly reduce pulmonary artery intimal hyperplasia, smooth muscle hypertrophy and vascular wall thickness. The drug is expected to turn pulmonary arterial hypertension which is a fatal cardiovascular disease with less than three years survival averagely into a manageable chronic disease, bringing hopes to the patients worldwide.

 


The results of the phase Ia clinical trial showed that GMA301 was safe.The drug is supported to be administered once a month with good safety profile, which will greatly improve patient compliance and effectively reduce the burden of patients.