A Phase 1A trial for GMA301 was completed this year in Australia for pulmonary arterial hypertension (PAH). This trial demonstrated a positive safety profile for a range of doses of the therapy. The half life of this therapy was shown to be 500-570 hours.
Now, Gmax Biopharm has announced that they have dosed the first patient in the Phase 1B trial. This investigation is a multi-center, international clinical trial for PAH. The primary investigators of this trial are Zhicheng Jing from China and Raymond Benza from the United States.
Researchers believe GMA301 holds promise for PAH. In animal models, it has shown ability to reduce-
- Pulmonary vascular thickening
- Right ventricular pressure
It has also been shown to prevent vascular remodeling in trials with monkeys.
Of course, human clinical trials are essential to validate these results. If they do, PAH could become a much more manageable condition.
GMA301 is a an antibody drug. It is a humanized mAB (IgG4) against ETa. This therapy is the first mAB developed as a therapy for PAH. So far, it has shown efficacy, tolerability, and safety. Additionally, this therapy has a long half-life which means that it can make the drug more convenient for patients. This means that patients would only have to take the treatment once a month. When patients have to think about their treatments less, it often improves their compliance in taking their medication.
GMA301 has already been given orphan drug designation from the FDA.
GMAX Biopharm is a pharmaceutical company based out of China. First established in 2010, this company focuses on antibody drugs that target GPCRs. Their profile includes metabolic conditions, cardiovascular conditions, and cancers.
Currently, they have 4 ongoing development programs.
- GMA102 for Type 2 diabetes
- GMA105 for obesity
- GMA301A for PAH in adults
- GMA301B for PAH in children
You can read more about this company and the research for this PAH therapy here.