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Gmax initiates the multi-region, multi-center clinical trial of Getagozumab in PAH patients


Gmax initiated the multi-region, multi-center clinical trial of Getagozumab in pulmonary arterial hypertension (PAH) patients.
The phase Ia clinical trial has finished in the Q3, 2018. Gmax has selected a global experienced CRO for the following multi-region multi-center phase Ib clinical trial. This trial will include major sites in PAH treatment and management, and will invite influential KOLs as principle investigators in China and US. The phase Ib trial is about to recruit WHO Group 1 PAH patients, to investigate the safety, PK and PD of multiple doses of GMA301, to support the following phase II/III trials. This trail will be the first multi-region clinical trial of a China biopharmaceutical for cardiovascular diseases.
Gmax has already requested a pre-IND meeting with US FDA, to discuss the phase Ia results and phase Ib trial design. The pre-IND meeting is in January 2019. This is the first time that a Chinese sponsor to have a discussion with US FDA for an innovative biopharmaceutical for cardiovascular disease, also the first China company to submit an IND application for a cardiovascular innovative biopharmaceutical product.
About Getagozumab
Getagozumab is the first ETa antibody therapeutic candidate in the world, for treatment of pulmonary arterial hypertension (PAH), a lethal rare disease. It has been granted with “Orphan Drug Designation” by the FDA.
Preclinical and early clinical data has demonstrated that Getagozumab is significantly superior than the current therapies, and it is expected to be a next-generation long-acting PAH drug.
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.