GMA102 has been approved for the IND in August 2018, in China. GMAX has initiated a multi-center, randomized, double-blinded, placebo controlled clinical trial in China.

 

GMAX has invited China influential KOL as the principle investigator for this clinical trial, is about to recruit adult type 2 diabetes patients, to further investigate the safety and efficacy in the multiple dosing trial. The trial is approved by the China Human Genetic Resources Management Office, and first patient dose is expected in early 2019.

 

The ongoing phase Ib/IIa clinical trial of GMA102 in Australia and New Zealand has finished dosing of the 2nd cohort and the recruitment of the 3rd cohort. From the preliminary results of the finished two dosing cohorts, GMA102 has demonstrated expected efficacy, is safe and well tolerated. The phase Ib/IIa trial is expected to finish in Q3, 2019.

 

GMAX is planning to initiate a multi-region, multi-center phase II/III clinical trial in China, US and Australia. The trial will be the pivotal study for BLA application.

 

About GMA102
Glutazumab is a long-acting GLP-1R antibody developed from Gmax’s proprietary GPCR antibody platform, for the treatment of type 2 diabetes and obesity. Preclinical and early clinical data from the phase 2 study demonstrated promising blood glucose and body weight lowering effects of Glutazumab. Glutazumab is potentially to be developed as a bi-weekly/monthly dosing GLP-1R agonist product for the type II diabetes and obesity. 

 

About Gmax Biopharm
Gmax Biopharm is one of the top innovative GPCR antibody companies, focusing on the new antibody therapeutics development for cardiovascular diseases, metabolic disorders and cancer treatment. Headquarter in Hangzhou, China, with branch offices in Australia and US. GMAX aims for global market, clinical development simultaneously in China and ex-China.