A recent press release from Gmax Biopharm announced that the first patient has received its humanised monoclonal antibody drug, GMA301, to investigate the drug’s efficacy for the treatment of pulmonary arterial hypertension (PAH). The drug is administered intravenously and can be dosed on a monthly schedule because of its long-lasting half-life. Therefore, it may be more convenient and increase therapy compliance for patients.
The PAH disease space has been transformed from an area with only a few therapies to a highly competitive market. Current treatments have improved patient outcomes and have brought about the means to help control this fatal disease, but significant unmet needs remain for a cure for the disease and for increasing patients’ survival rates. Smaller pharmaceutical companies such as Gmax Biopharm have risen to the goal of meeting these unmet needs by developing novel therapies. Gmax Biopharm’s GMA-301 is a monoclonal antibody in early stage development for PAH. The drug is an endothelin receptor antagonist (ERA). Its mechanism of action is to antagonise the endothelin A receptor blocking the vascular pressure increase caused by endothelin to achieve remission of PAH symptoms and improve both exercise capacity and hemodynamics in patients. Key opinion leaders interviewed by GlobalData have emphasised that the use of ERAs has constantly increased among patients in functional classes 2–4, and is expected to continue increasing in the future as well.
Currently marketed PAH therapies are weak anti-proliferative agents that focus on dilating the partially occluded vessels. They are not effective at reversing vascular remodelling or preventing the need for a lung transplant. In preclinical testing on animal models, GMA301 showed improved efficacy in lowering right ventricular pressure and hypertrophy, as well as reducing pulmonary vascular thickening and preventing vascular modeling. The FDA has granted GMA301 orphan drug designation status, which means that it is entitled to regulatory and financial incentives that will facilitate its development.
A Phase Ib clinical study is looking to enrol 36 patients with PAH, ages 18–75 years, to take part in a 22-week trial. The trial endpoints will include changes in pulmonary vascular resistance and functional capacity in patients. According to GlobalData’s Pharma Intelligence Center drug database, Gmax Biopharm currently has three drugs in active stages of development that are indicated for cardiovascular and metabolic disorders: GMA-102 (Type 2 Diabetes), GMA-105 (obesity), and GMA301 (PAH).
