Australian-backed triple-combination hypertension treatment proceeding to regulatory submission

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Australian-supported research recently published in three leading medical journals has confirmed positive Phase 3 clinical trial results for a triple combination that could revolutionise the management and treatment of high blood pressure.

George Medicines candidate GMRx2 is a polypill that combines multiple medicines into a single tablet. It contains the commonly used hypertension medicines telmisartan, amlodipine, and indapamide.

It originates from a 20-year research program by The George Institute for Global Health and Brandon BioCatalyst member. George Medicines is a spin-out from The George Institute for Global Health.

Brandon Capital, Australasia’s leading life sciences venture capital firm, was an early backer and continues co-investing alongside The George Institute, Federation Private Equity, and private health insurer BUPA.

In the largest Phase 3 trial, published in The Lancet, standard and half-dose forms of GMRx2 were tested against dual combinations of its component drugs. The trial involved 1,385 patients in Australia, the Czech Republic, New Zealand, Poland, Sri Lanka, the UK, and the US.

The results indicate that GMRx2 was significantly more effective at controlling blood pressure than the more commonly used dual combinations.

Professor Anthony Rodgers, senior professorial fellow at The George Institute and chief medical officer at George Medicines, said, “These findings, now published in The Lancet, provide robust evidence for the potential of GMRx2 to transform hypertension management globally.

“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.”

Hypertension, or high blood pressure, is a leading preventable cause of heart disease and death, and there is broad consensus that long-term blood pressure reduction also lowers the risk of heart attacks, stroke and dementia. Over 4 million Australians have hypertension, and blood pressure control rates are low in Australia compared to other OECD countries.

The Phase 3 trial data published in the Journal of the American College of Cardiology showed that GMRx2 triple quarter and triple half doses delivered significant blood pressure reductions compared to placebo. The finding published in the Journal of the American Medical Association, GMRx2 outperformed a traditional treatment plan starting with just one drug.

Dr Stephen Thompson, the co-founder and managing partner of Brandon Capital, said, “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.”

“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,” he said.

George Medicines said it will now move forward with its application for regulatory approval of GMRx2.