The George Institute team delivers blood pressure ‘super pill’

High blood pressure is the leading preventable cause of heart disease but researchers have discovered a new three-in-one super pill that may revolutionise treatment.

A new three-in-one daily pill that could revolutionise the treatment of high blood pressure has shown in a major clinical trial that you can teach old dogs new tricks.

In this case it is a novel combination of low doses of three existing blood pressure medications that have been developed into one new “super pill”.

International studies led by Australian researchers at The George Institute for Global Health showed this polypill helped to control high blood pressure in more than 70 per cent of patients on the trial within a month, and maintained it.

The Institute is an independent medical research body and the early work on the new drug was funded by local investors including Melbourne-based Brandon Capital with The George Institute, Federation Private Equity and health insurer BUPA.

Over a billion people worldwide have high blood pressure and most need to take more than one medication daily to help control it.

The research team hopes to bring the drug, with the working name of GMRx2, to market within the next two years pending regulatory approval.

Anthony Rodgers is a senior professorial Fellow at The George Institute and also Chief Medical Officer at George Medicines, an independent spin-out company helping to commercialise the Institute’s research.

He said the drug resulted from a 20-year research program by George Health and had its early funding from a grant by the National Health and Medical Research Council in 2017.

“With three dose versions, it is potentially suitable for people with mild, moderate and severe blood pressure,” Prof Rodgers said. “And what we know about the condition is that it’s not really treated well enough in a large majority of cases, and each extra millimetre reduction you get a couple of per cent extra cardiovascular risk reduction, and so it really pays to have something that’s highly effective.”

Mor than a billion people worldwide have high blood pressure and the majority need to take more than one medication daily to help control it well.

The results of the main phase III trial have been published in The Lancet and also presented at the European Society of Cardiology.

It revealed a total of 1385 patients in Australia, the Czech Republic, New Zealand, Poland, Sri Lanka, the UK and the US took part with promising results.

The Institute says it showed 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”.

More than four million Australians have hypertension, also known as high blood pressure.

Two further trials were published in JAMA and the Journal of American College of Cardiology, showing superiority compared to standard protocols and also against placebo.

“That eureka moment is when you see that you can both get better blood pressure control, but also without increasing side effects.” Prof Rodgers said. “That’s such an important thing for a long-term treatment. Also, it’s a simplified therapy, so that is more practical for physicians and for patients.

“Delivering that all at one go is why we think it’s got such promise. This is a game-changer.”

Prof Rodgers said key was that the new drug uniquely used very low doses of three existing drugs.

“By using those low doses … you avoid most of the side effects, but you retain a lot of the benefit, even when you’re down at a quarter of the normal dose,” he said.

Prof Rodgers said another benefit was despite the three drugs being on the market for a long time, this Australian innovation was getting more out of them.

“You’ve got a lot of familiarity with the drugs, they’ve got a great safety profile, but they just weren’t available in the right formulation for prescribers,” he said. “That was the trigger for the research.”

As the company prepares to apply for FDA approval for the drug’s use in the US next year and also the Therapeutic Goods Administration in Australia, another large clinical trial is underway to see if the super pill can help prevent strokes in people who have previously had one.

The team may also look at using the innovation to make the most of other existing medicines.

“Similar approaches could be used in other areas: treatment of high cholesterol, treatment of diabetes for example,” Prof Rodgers said. “We would love to use this as a springboard to make those kinds of medicines more accessible, affordable, available and convenient for patients.”

AT A GLANCE

• Hypertension, or high blood pressure, is the leading preventable cause of heart disease and death

• Long-term blood pressure reduction can help lower the risk of heart attacks, stroke and dementia

• More than four million Australians have hypertension

Originally published as The George Institute team delivers blood pressure ‘super pill’