Home-grown hypertension polypill heads to regulatory approval

Australian-supported research has revealed remarkable Phase III clinical trial results for an innovative triple drug combination in the treatment of hypertension. GMRx2, developed by George Medicines, is a polypill that combines multiple medicines into a single tablet.

The Phase III trials involved testing standard and half-dose forms of GMRx2 – a novel combination of telmisartan, amlodipine, and indapamide – against dual combinations of its component drugs. The study included 1,385 patients across Australia, the Czech Republic, New Zealand, Poland, Sri Lanka, the UK, and the US.

Professor Anthony Rodgers, Senior Professorial Fellow at The George Institute and Chief Medical Officer at George Medicines, commented, “These findings provide robust evidence for the potential of GMRx2 to transform hypertension management globally.”

He continued, “The superior efficacy of this triple combination therapy compared to dual combinations, coupled with its good tolerability, addresses key challenges in current hypertension treatment approaches and directly supports recent guideline recommendations. Subject to regulatory approval, we believe GMRx2 could play a crucial role in addressing the global burden of hypertension and improving patient outcomes.”

The primary outcome, mean home systolic blood pressure (SBP) at 12 weeks, was 126 mm Hg in the GMRx2 group, which was 2.5 mm Hg lower than the telmisartan-indapamide group (p<0.0001), 5.4 mm Hg lower than the telmisartan-amlodipine group (p<0.0001), and 4.4 mm Hg lower than the amlodipine-indapamide group (p<0.0001).

Hypertension, or high blood pressure, is the leading preventable cause of heart disease and death worldwide. It is widely acknowledged that long-term blood pressure reduction lowers the risk of heart attacks, stroke, and dementia. In Australia, over 4 million people suffer from hypertension, with control rates trailing behind other OECD countries.

Dr Paul Whelton, Chair of the trial’s steering committee, Show Chwan Chair of Global Public Health at Tulane University, and President of the World Hypertension League, noted, “This trial, conducted across seven countries and diverse populations, demonstrates that GMRx2 provides significantly better blood pressure control compared to dual combinations while maintaining an excellent safety profile.”

He added, “The findings are particularly noteworthy as they show efficacy at lower blood pressure levels, aligning with the latest guideline recommendations. This new single-pill combination has the potential to address the critical need for more effective and tolerable treatment options to achieve and maintain blood pressure control in the many patients who remain uncontrolled on current therapies.”

Dr Stephen Thompson, co-founder and Managing Partner of Brandon Capital, expressed pride in the innovation, saying, “Brandon Capital is thrilled to be part of the George Medicines journey. Their success highlights the ability of Australian research to address critical global health issues when it receives the necessary timely investments and capability enhancements.”

He added, “GMRx2 is a home-grown innovation that has the potential to make a significant impact across the world, not just in the developed world, but in regions like sub-Saharan Africa, where hypertension is prevalent, but access to care is often limited.”

It originates from a 20-year research program led by The George Institute for Global Health, an independent medical research organisation and member of Brandon BioCatalyst. George Medicines is a spin-out of the institute, with backing from local investors who have played a pivotal role in advancing this innovation. These investors include Brandon Capital, Australasia’s leading life sciences venture capital firm, along with The George Institute, Federation Private Equity, and health insurer BUPA.

As George Medicines moves ahead with its regulatory approval process for GMRx2, there is optimism that this treatment will soon be available to transform the lives of millions with hypertension.

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