Home Business News Clinical trial begins in the UK to investigate three in one high blood pressure pill

Clinical trial begins in the UK to investigate three in one high blood pressure pill

by LLB staff reporter
17th Jan 22 12:34 pm

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 Medicine’s 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 added, “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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