27 November, 2024 MELBOURNE, Australia — In a significant international breakthrough for the more than one billion people suffering from hypertension, Australian-supported research recently published in three of the world’s leading medical journals – The Lancet, the Journal of the American Medical Association (JAMA) and the Journal of the American College of Cardiology (JACC) – has produced outstanding Phase III clinical trial results for an innovative triple combination of drugs, which could revolutionise the management and treatment of high blood pressure.
George Medicines candidate GMRx2, a polypill that combines multiple medicines into a single tablet, originates from a 20-year research program by The George Institute for Global Health, a prominent independent medical research institute and Brandon BioCatalyst member. George Medicines is a spin-out from The George Institute for Global Health.
Local investors supporting the Australian research have been instrumental in advancing this innovation. Brandon Capital, Australasia’s leading life sciences venture capital firm, was an early backer and continues to co-invest alongside The George Institute, Federation Private Equity, and health insurer BUPA.
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 1,385 patients in Australia, the Czech Republic, New Zealand, Poland, Sri Lanka, the UK and the US.
The results indicate that George Medicines’ triple combination pill, 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. Prof Anthony Rodgers, Senior Professorial Fellow at The George Institute and Chief Medical Officer at George Medicines, stated, “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 the 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 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% don’t have their blood pressure under control. 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 in Australia and other countries have shown that GMRx2 – a novel, proprietary combination of telmisartan, amlodipine, and indapamide developed in ultra-low dose (quarter-dose), low-dose (half-dose), and standard-dose options – is significantly more effective at controlling blood pressure than standard treatments.
Chair of the trial’s steering committee, Dr Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University, New Orleans, Louisiana, and President of the World Hypertension League, commented: “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.”
“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.”
The Phase III trial data published in JACC showed that GMRx2 triple ¼ and triple ½ doses both delivered significant blood pressure reductions compared to placebo, and the JAMA finding that GMRx2 outperformed a traditional treatment plan that begins with just one drug. Both studies showed excellent safety and tolerability profiles.
The clinical trial published in JAMA involved around 300 Black African participants with uncontrolled hypertension in Nigeria and found that the GMRx2 triple combination pill helped an impressive 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,” Dr 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.”
Dr Stephen Thompson, 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.
As George Medicines moves forward with its application for regulatory approval of GMRx2, there is hope that this innovative treatment will soon be available to transform the lives of millions of people worldwide dealing with hypertension.
ENDS
Media contacts – Australia
Icon Agency: brandoncapital@iconagency.com.au
About George Medicines
George Medicines is a late-stage biopharmaceutical company addressing significant unmet needs in the treatment of cardiometabolic diseases with innovative combinations of best-in-class existing treatments designed for optimal efficacy and safety. Combining best-in-class molecules from existing medicines in novel low-dose formulations, George Medicines is developing innovative and proprietary treatments to be more efficacious, safer and accessible than currently available treatment options. These multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes and therapy adherence in patients with cardiometabolic disorders, including hypertension and diabetes, each of which remains the leading causes of premature death and disability worldwide.
About Brandon Capital and Brandon BioCatalyst
Brandon Capital is Australasia’s leading life science venture capital firm, with a solid global presence supported by key partnerships and team members across the US and UK. Brandon Capital supports life science companies from early-stage seed investment to expansion capital from proof-of-concept to commercialisation. Managed and operated by Brandon Capital, Brandon BioCatalyst is a collaboration of over 50 leading medical research institutes, investors, and governments united in progressing the next generation of medical innovations that improve health and save lives.
About The George Institute
The George Institute for Global Health is an independent medical research institute aiming to improve the health of millions of people worldwide by generating effective, evidence-based and affordable solutions to the world’s biggest health challenges. Established in Sydney, with major centres in China, India and the UK, it has projects in more than 45 countries and affiliations with world-class universities. In 2018, The George Institute was ranked the number-one independent research institute in Australia by Times Higher Education. George Medicines is an independent spin-out company from The George Institute for Global Health, which was established to commercialise the Institute’s research. https://www.georgeinstitute.org/
