Three-in-one pill could transform hypertension treatment

New Australian research published in three of the world’s leading medical journals has produced impressive Phase III clinical trial results for an innovative combination of drugs, which could revolutionise the management and treatment of high blood pressure.

Hypertension, or high blood pressure, is the leading preventable cause of heart disease and death. The World Health Organization (WHO) estimates that over 1.2 billion adults have hypertension, with two-thirds living in low- and middle-income countries, and 80% do not have their blood pressure under control. The good news is, every 1 mmHg reduction in systolic blood pressure reduces the risk of major cardiovascular events, such as heart attack and stroke, by approximately 2%.

Data collected from recent trials, conducted across seven countries and diverse populations, has now shown that GMRx2 — a novel, proprietary combination of telmisartan, amlodipine and indapamide developed in ultralow-dose (quarter-dose), low-dose (half-dose) and standard-dose options — is significantly more effective at controlling blood pressure than standard treatments, while maintaining an excellent safety profile. The polypill originates from a 20-year research program by the Sydney-based George Institute for Global Health, and was developed by spinout company George Medicines.

“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,” said Dr Paul Whelton, chair of the clinical trial steering committee.

“The findings are particularly noteworthy as they show efficacy at lower blood pressure levels, aligning with the latest guideline recommendations.”

In the largest of the Phase III trials, published in The Lancet, standard and half-dose forms of GMRx2 were tested against dual combinations of its component drugs, involving 1385 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, highlighting its potential to change people’s lives worldwide.

“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,” said Professor Anthony Rodgers, Senior Professorial Fellow at The George Institute and Chief Medical Officer at George Medicines. “Subject to regulatory approval, we believe GMRx2 could play a crucial role in addressing the global burden of hypertension and improving patient outcomes.”

Trial data published in the Journal of the American College of Cardiology (JACC) showed that GMRx2 triple ¼ and triple ½ doses both delivered significant blood pressure reductions compared to placebo, while data in the Journal of the American Medical Association (JAMA) showed that GMRx2 outperformed a traditional treatment plan that begins with just one drug. Indeed, the JAMA trial — which involved around 300 Black African participants with uncontrolled hypertension in Nigeria — found that the GMRx2 triple combination pill helped 62% of patients control their blood pressure, surpassing the 28% level of control seen with standard care.

“These were certainly the results we were hoping for,” Rodgers said. “It is worth bearing in mind that ‘standard care’ in this trial was much better than average care — even in high-income countries, such good results are rarely seen; it was especially exciting to see the new strategy do even better.”

Brandon Capital, the life sciences venture capital firm, was an early backer in the research and continues to co-invest alongside The George Institute, Federation Private Equity and health insurer Bupa. Dr Stephen Thompson, co-founder and Managing Partner of Brandon Capital, said GMRx2 has the potential to make a significant impact across the world — including in developing countries where access to care is often limited — and that its success highlights the ability of Australian research to address critical global health issues when it receives the necessary investments.

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