Nov 14, 2022, Gmax Biopharm LLC. announced that its investigational New Drug (IND) application for GMA131 injection, the global first ETa-specific monoclonal antibody, was approved by the US FDA on Nov 11, 2022 for the clinical study of diabetic kidney disease (DKD).

Dr. Shuqian Jing, Founder and Chairman of Gmax Biopharm, said: “GMA131 is the global first ETa-specific monoclonal antibody developed by Gmax Biopharm. It specifically blocks ET-1/ETa signal transduction with no cross-reactivity to ETb. GMA131 is the same molecule as GMA301 which is in a Phase Ib trial of pulmonary arterial hypertension (PAH) in China/USA. Pre-clinical and clinical studies indicate that this molecule has great safety profile, and better efficacy than small molecule endothelin receptor antagonist (ERA) in the high fat diet-STZ induced DKD model. GMA131 is expected to be a new generation drug of DKD.”

Endothelin (ET-1) and its receptors (ETa and ETb) are widely distributed in the kidney. ET-1/ETa axis regulates renal hemodynamics, function and structural integrity of glomerular filtration barrier, mesangial cell proliferation, extracellular matrix accumulation, inflammation, fibrosis etc., actively participating in the development and progression of DKD and chronic kidney disease. Meanwhile, ETb plays an important role in the regulation of salt-water homeostasis. Clinical trials of small molecule ERAs have shown that ETa selective antagonists can reduce proteinuria and improve renal function in DKD patients. However, water/sodium retention due to non-specific binding with ETb and the adverse effects due to the specific structure of small molecules are the main obstacles for clinical application of small molecule ERAs. GMA301, the same molecule as GMA131, has shown superior safety profile in healthy volunteers and pulmonary arterial hypertension patients, without water/sodium retention common with small molecule ERAs.

DKD, as the leading cause of chronic kidney disease and end stage renal disease (ESRD), is one of the most important complications of diabetes. About one third of diabetics will develop DKD, and will eventually progress to ESRD within about 5 years if presented with massive proteinuria.

According to IDF Diabetes Atlas 10th Edition 2021, approximately 537 million adults (20-79 years) are living with diabetes worldwide in 2021, about 1 in 10 adults. The numbers are predicted to rise to 783 million and 12.2% in 2045. DKD has become one of the major diseases that seriously endanger human health and economy development.

As the first ETa-specific monoclonal antibody drug worldwide, GMA131 will take its full advantages to benefit the DKD patients!

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