GMAX Biopharm gives first does of anti-body drug treating PAH in phase 1B trial
- Category: Antibodies
- Published on Monday, 26 October 2020 13:12
- Hits: 709
HANGZHOU, China I October 26, 2020 I Gmax Biopharm today announces that the first dose of GMA301 was given to the patient in its phase 1B trial to investigate the drug efficacy to treat pulmonary arterial hypertension (PAH). GMA 301 is the first antibody drug for PAH treatment. In the phase 1A trial, it demonstrated superior safety profile in a single dose of 75, 200, 500, and 1000 mg, with a half-life of 500-570 hours. The lead PIs for this international multi-center (China/USA) trial are Dr. Zhicheng Jing (China) and Dr. Raymond Benza (USA).
"We are extremely excited about this event as GMA301 shows superior efficacy in reducing right ventricular pressure and hypertrophy, and pulmonary vascular thickening and preventing vascular remodeling during the test in MCT-induced PAH cynomolgus monkeys. If human trials confirm these results, we see hope for the first time that PAH can be turned into a manageable chronical disease," said Dr. Shuqian Jing, founder and CEO of Gmax. "Also, its long-lasting half-life makes monthly dosing possible and this will substantially improve convenience and compliance of drug use for patients."
About GMA301: a humanized mAb (IgG4) against endothelin receptor type A (ETa), is the first mAb drug developed for PAH. It has demonstrated excellent efficacy, safety and tolerability. Its long half-life makes it a promising candidate to optimize drug convenience (1MQ). Orphan drug designation has been granted by FDA. Phase 1A clinical trial in Australia was completed in 2020.
About Gmax Biopharm LLC: Gmax is a clinical stage 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 four drug development programs in different stages of clinical trials: GMA 102 (type 2 diabetes), GMA105 (obesity), GMA301A (PAH for adult), and GMA 301B (PAH for children). Its unique Bibody technology empowers acting on two or more different targets to improve drug efficacy or broaden indications. www.gmaxbiopharm.com
SOURCE: Gmax Biopharm