Clinical trial begins in the UK to investigate 3-in-1 high blood pressure pill
January 17, 2022
- 500 UK patients to be treated as part of global trial
- Investigational single-pill combination offers potential to substantially increase efficacy and improve adherence to treatment, while minimising side effects
George Medicines, a late-stage drug development company focused on providing innovative and accessible medicines for the world’s leading causes of death, today announced that its proprietary triple low-dose combination pill, GMRx2, will be trialed in UK patients with high blood pressure (hypertension), in a collaboration with ICTU Global, an Academic Clinical Research Organisation at Imperial College London.
Hypertension is a major preventable risk factor for vascular dementia and heart and kidney disease in the UK, and is responsible for more than half of all heart attacks and strokes, costing the NHS over £2.1 billion each year. Around one in three UK adults have hypertension, half of whom are not diagnosed or receiving sufficient treatment, and up to 80 per cent of adults who are diagnosed and treated do not take all of their prescribed medication.
It is quite common for patients to take more than one type of blood pressure medication at the same time because they work in different ways, with some people taking three or more different pills. In its latest Guideline for the Pharmacological Treatment of Hypertension in Adults, the World Health Organization (WHO) – in keeping with the International Society of Hypertension Guidelines of 2020 – suggests combination therapy, preferably with a single-pill combination, to improve adherence and persistence, as an initial treatment.
Approximately 500 patients are expected to be recruited for the trial from hospitals and GP practices across England. They will join 1,000 patients already being recruited across international sites including the US and Australia. The phase III trial is the final stage of development, with results expected to support a regulatory filing for approval.
GMRx2 is George Medicines’ most advanced candidate in late-stage development. A single-pill triple combination, it contains low doses of the commonly used hypertension medications, telmisartan, amlodipine and indapamide. The trial, which will compare the safety and efficacy of GMRx2 against dual combinations of the same components over 12 weeks, follows successful earlier studies of a low-dose triple combination which significantly outperformed traditional high blood pressure treatments without additional side effects.
George Medicines, a spin-out company from The George Institute for Global Health, one of the world’s leading independent medical research institutes, is focused on developing single-pill combinations of
best-in-class existing medicines with the potential to better manage non-communicable diseases such as hypertension, cardiovascular disease and type 2 diabetes. These investigational therapies are intended to provide the optimal balance of high efficacy and improved safety, with potential for significant improvements in clinical outcomes and long-term adherence to treatment.
ICTU Global is part of the Imperial Clinical Trials Unit (ICTU) and is recognised for its experience and expertise in the development and delivery of clinical trials in collaboration with industry, across a range of therapeutic areas. ICTU is led by Professor Neil Poulter who is Professor of Preventive Cardiovascular Medicine at Imperial College London and is past-President of the British Hypertension Society and the International Society of Hypertension and is one of the most cited academics in clinical medicine. He brings decades of experience at the forefront of academic and clinical research into hypertension. ICTU sits within Imperial College London as a department within the School of Public Health in the Faculty of Medicine and brings together academic, clinical and trial management expertise from across the Imperial College Academic Health Science Centre. ICTU Global is led by Professor Kausik Ray, Professor of Public Health at Imperial College London and Honorary Consultant Cardiologist at the Imperial College Healthcare NHS Trust. Professor Ray leads a team of highly experienced operational staff to deliver excellence in clinical trial management.
Stefan König, CEO at George Medicines, said: “This unique, three-in-one hypertension pill has the potential to substantially increase efficacy and improve adherence to treatment while minimising 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. We are delighted to collaborate with Imperial Clinical Trials Unit to expand our research into the UK, where high blood pressure remains a significant silent killer and many patients are still uncontrolled.”
Professor Neil Poulter, Director of Imperial Clinical Trials Unit (ICTU) and past-President of the International Society of Hypertension, said: “With only one third of the patients receiving treatment for high blood pressure being controlled, we must do better. Hypertension continues to present a significant burden, one brought more starkly into focus during the COVID-19 pandemic, which has seen patients with underlying conditions such as high blood pressure most vulnerable to serious illness. It is imperative that research continues to identify the best possible treatment for patients to better manage their condition. A therapy that can more effectively control a patient’s blood pressure and reduce the significant pill burden that can lead patients to discontinue therapy could help transform how we treat high blood pressure.”
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 Fixed Low-Dose Triple Combination Antihypertensive Medication vs Usual Care for Blood Pressure Control in Patients With Mild to Moderate Hypertension in Sri Lanka JAMA. 2018;320(6):566-579. doi:10.1001/jama.2018.10359
Consilium Strategic Communications
David Daley, Allison Connolly, Lindsey Neville
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About George Medicines
George Medicines is a late-stage drug development company focused on improving the management of non-communicable diseases with proprietary, innovative, single-pill, fixed-dose combinations of existing medicines.
Combining best-in-class molecules from existing medicines in novel fixed- and low-dose formulations, George Medicines is developing innovative and proprietary treatments that are more efficacious, safer and affordable than currently available treatment options. These single-pill, fixed-dose combinations offer the potential to bring significant improvements in clinical outcomes and therapy adherence in patients with cardiometabolic diseases such as heart disease, hypertension, and diabetes, which remain the leading causes of premature death and disability worldwide.
George Medicines is building a strong and diversified pipeline of patented, single-pill, fixed-dose combination therapies in late-stage development. Its lead candidate for the initial treatment of high blood pressure, GMRx2, has received clearance from the US Food and Drug Administration (FDA) to enter Phase III development.
George Medicines is a spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes in non-communicable diseases. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital Partners, Australia’s leading biomedical venture capital firm, backed by the Australian Government. For more information please visit www.george-medicines.com
Hypertension, or elevated blood pressure, is a serious medical condition that significantly increases the risk of heart attack, stroke and kidney disease, among other issues. According to the WHO, hypertension affects 1.1 billion people worldwide, with two-thirds living in low- and middle-income countries. More than 700 million people around the world with hypertension are not receiving the treatment they need. It remains one of the top causes of death and disease throughout the world, despite being easily detectable and effectively treatable.
GMRx2 is a single pill, triple component combination medicine and has been developed in 3 dosage forms: telmisartan 10mg, amlodipine 1.25mg and indapamide 0.625mg; telmisartan 20 mg, amlodipine 2.5 mg and indapamide 1.25 mg; and telmisartan 40 mg, amlodipine 5 mg and indapamide 2.5 mg.
For more information on the GMRx2 trials please visit clinicaltrials.gov (NCT04518293 and NCT04518306)