George Medicines to analyze three-in-one hypertension pill in UK trial
The trial will assess the efficacy and safety of GMRx2 against dual cocktails of the same components for 12 weeks.
George Medicines has announced the launch of a clinical trial to evaluate its three-in-one, low-dose combination pill GMRx2 in individuals with high blood pressure (hypertension) in the UK.
GMRx2, which is in late-stage development, comprises low doses of telmisartan, amlodipine, and indapamide, which are the common hypertension therapeutics.
The investigational pill is claimed to boost adherence to therapy while lowering side effects.
The trial will be carried out in partnership with an academic clinical research organization, ICTU Global, at Imperial College London, UK.
It will compare GMRx2’s efficacy and safety against dual cocktails of the same components for a period of 12 weeks.
The international trial is expected to enroll nearly 500 subjects from hospitals and GP practices in England.
Currently, 1,000 subjects are being enrolled across global trial centres including the US and Australia.
The latest trial comes after previous successful studies, where the low-dose triple combo substantially outperformed standard hypertension therapies without further side effects.
With the Phase III trial being the concluding stage of development, results are expected to support a regulatory filing to obtain approval.
George Medicines CEO Stefan König said: “This unique, three-in-one hypertension pill has the potential to substantially increase efficacy and improve adherence to treatment while minimizing side effects.
“At George Medicines, we believe affordable, single-pill combinations of existing medicines could help patients to better manage non-communicable diseases such as hypertension, cardiovascular disease, and type 2 diabetes.”
A key avoidable risk factor for vascular dementia, heart and kidney disease in the UK, hypertension causes more than 50% of all heart attacks and strokes. This costs the National Health Service (NHS) more than £2.1bn every year.