Gmax Biopharm announced that the first patient has received its humanized monoclonal antibody drug, GMA301, as part of investigations around the drug’s efficacy for the treatment of pulmonary arterial hypertension (PAH). As the drug is administered intravenously, and can be dosed on a monthly schedule because of its long-lasting half-life, it may be more convenient and increase therapy compliance for patients, according to GlobalData, a leading data and analytics company.

Kajal Jaddoo, Associate Pharma Analyst at GlobalData, comments: “There is a significant unmet need in the PAH treatment space for therapies that increase patient survival rates, as many current options simply focus on disease control – rather than cure the disease. Smaller pharmaceutical companies such as Gmax Biopharm have risen to the goal of meeting these unmet needs by developing novel therapies.”

GMA-301’s mechanism of action is to antagonize 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 emphasized that the use of endothelin receptor antagonists has constantly increased among patients in functional classes 2–4, and is expected to continue increasing in the future as well.

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.

Jaddoo continues: “Currently marketed PAH therapies are weak anti-proliferative agents that focus on dilating the partially occluded vessels. They are not effective at reversing vascular remodeling or preventing the need for a lung transplant. GMA301 has the potential to address this issue as the drug has shown superior efficacy in preventing vascular remodeling in a monkey PAH model, if similar results are confirmed in human trials, PAH can be turned into a manageable disease.”

Gmax BioPharm’s phase Ib clinical study is looking to enroll 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. The trial is expected to complete June 2022.

Jaddoo adds: “According to GlobalData’s Pharma Intelligence Center drug database, Gmax Biopharm currently has three additional 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).”