HANGZHOU, China, Nov. 11, 2021 /PRNewswire/ — Gmax Biopharm today announces that the first dose of GMA106 was given to human subjects in a phase 1 study to investigate the safety, pharmacokinetics, and pharmacodynamics of this drug in the treatment of obesity. The study is a single dose, placeable controlled, double blind, randomized, dose escalating study, with 6 dose cohorts each containing 8 subjects. The dosages are 4, 10, 20, 40, 60, and 80mg. Gmax is also in the process of filing INDs for phase 1b/2 trials in China and USA.
“We are extremely excited about this event as GMA106 shows superior efficacy in weight reduction of non-human primate in pre-clinical studies. It can be a significant breakthrough as the second generation of drugs in our developmental pipeline for the treatment of obesity and T2DM. While GMA102 (T2DM) is already in phase 3 trial in China, GMA106 offers hope to fill more unmet medical needs in the obesity/T2DM areas. Additionally, this new drug could be used in combination with GMA102 for even better treatment of T2DM and obesity”, said Dr. Shuqian Jing, founder and CEO of Gmax.
About GMA106: GMA106 is Gmax’s second generation mAb therapy for the treatment of obesity/T2DM/NASH. It is rationally designed utilizing Gmax’s GPCR mAb and M-Body technologies. This M-Body is composed of an anti-GIPR antibody fused with a GLP-1 peptide. It can simultaneously interact with GLP-1R and GIPR and regulate both signaling pathways to synergistically suppress appetite, reduce blood glucose and fat accumulation, and improve insulin resistance. Therefor GMA106 is a new and potentially a better treatment for obesity, diabetes and NASH (non-alcohol steatohepatitis).
About Gmax Biopharm LLC.: Gmax is a clinical stage biopharmaceutical company established in 2010 and headquartered in Hangzhou, China. It’s a global company focusing on R&D, production and commercialization of antibody drugs targeting GPCRs. Gmax mainly works on cardiovascular, metabolic and cancer areas. Currently there are five drug development programs in different stages of clinical trials: GMA102 (type 2 diabetes), GMA105 (obesity), GMA301A (PAH for adult), GMA301B (PAH for children), GMA106 (obesity/T2DM/NASH). GMA131, an ETA specific ERA mAb for DKD/CKD, is about to enter into phase 1/2 trial in China and USA. Gmax’s unique M-body technology empowers acting on two or more different targets to improve drug efficacy or broaden indications.