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George Medicines initiates two Phase III trials of triple combination candidate to treat hypertension

·6-min read

George Medicines initiates two Phase III trials of triple combination candidate to treat hypertension

  • Novel proprietary triple low-dose combination pill has been shown to outperform traditional blood pressure treatments without additional side effects in earlier clinical research

  • Lead candidate in Company’s pipeline of proprietary fixed-dose combination therapies targeting high unmet need in large patient populations suffering from non-communicable diseases such as CVD and Diabetes

London, UK, 1 July 2021 George Medicines, a late-stage drug development company focused on providing innovative and accessible medicines for the world’s leading causes of death, today announces the initiation of two Phase III trials investigating its proprietary triple combination candidate, GMRx2, as a first-line treatment for hypertension.

Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients1 and a previous trial indicated triple low-dose combination therapy is statistically and clinically superior to standard of care, achieving better blood pressure control without increasing serious adverse effects. GMRx2 is a single pill triple combination in novel and proprietary dosage strengths containing telmisartan, amlodipine and indapamide, targeted for first line therapy to control hypertension.

George Medicines, a venture-backed spin-out company from The George Institute for Global Health, one of the world’s leading independent medical research institutes, is using its deep insights from academic research coupled with drug development and formulation expertise to combine best-in-class existing treatments in novel, fixed, ultra-low-dose combinations. These 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.

Hypertension is a major preventable risk factor for heart disease, stroke, kidney failure and heart failure, leading causes of mortality and morbidity in the USA. Over 100 million US adults have hypertension and only 1 in 4 have adequately controlled blood pressure – tens of millions need to start treatment, and tens of millions more need better treatment.2 Globally, over a billion people worldwide have hypertension, with most (two-thirds) living in low- and middle-income countries. Fewer than one in five people with hypertension have the problem under control.3

The Phase III trials follow successful earlier trials of a low dose triple combination which significantly outperformed traditional high blood pressure treatments without additional side effects. In those trials 70 per cent of patients receiving the combination reached their blood pressure target compared to just over half on their existing therapy4. If successful in Phase III trials, GMRx2 could be available for patients by 2023, subject to regulatory approval by the US Food and Drug Administration (FDA).

The first Phase III trial is an international, multi-center, randomised, double blind, active controlled, parallel group study, evaluating the safety and efficacy of GMRx2 in patients with high blood pressure compared to dual combinations of the same components. The trial’s primary outcome measure will be change in home systolic blood pressure (SBP) from baseline to week 12. The trial will enroll 1,500 patients and will be conducted across sites in seven countries, including the US and Australia.

A second Phase III trial with 250 patients is investigating the efficacy and safety of GMRx2 compared to placebo for the treatment of mild hypertension. The primary outcome measure of this trial will be the difference in change in home SBP from baseline to Week 4.

Prof Dr Anthony Rodgers, Chief Scientific Officer of George Medicines, said: “We are very pleased to be starting these two Phase III trials. High blood pressure is a leading cause of preventable morbidity and mortality globally and most people who are treated remain uncontrolled. Novel, low-dose combinations have great potential to substantially increase efficacy and improve adherence, while minimising adverse effects. George Medicines has recognised this and developed a unique, three component, single-pill combination, GMRx2, with the potential for superior efficacy, safety, adherence and access, beyond currently available treatment options.

Dr Paul K. Whelton, MB, MD, MSc, FAHA, Show Chwan Chair in Global Public Health, Tulane University, and President-elect, World Hypertension League said: “Following the US Surgeon General’s Call to Action to Control Hypertension announced at the end of last year it is very good news that these two trials evaluating GMRx2 as a treatment for hypertension have commenced. Control of hypertension is a major unmet need, brought into more focus by COVID-19, to which patients with underlying conditions are most vulnerable. Trials such as those being conducted by George Medicines have the potential to help the millions of people worldwide with hypertension to live longer and healthier lives by enabling the provision of simple, affordable, effective and accessible medicines. If successful, these trials may have the potential to change the treatment paradigm of 1st line hypertension.

For more information on the trials please visit clinicaltrials.gov (NCT04518293 and NCT04518306)

End –

References

  1. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2018;71:e127-e248

  2. U.S. Department of Health and Human Services. The Surgeon General’s Call to Action to Control Hypertension. Washington, DC: U.S. Department of Health and Human Services, Office of the Surgeon General; 2020

  3. World Health Organization https://www.who.int/news-room/fact-sheets/detail/hypertension

  4. 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

Contacts:

George Medicines
Stefan König, Chief Executive Officer
info@george-medicines.com

Consilium Strategic Communications
David Daley, Allison Connolly, Lindsey Neville
Tel: +44 (0) 203 709 5700
georgemedicines@consilium-comms.com

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

About Hypertension
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. It is known as a “silent killer” as most people are unaware of the problem unless they are regularly tested. It is a major cause of premature death.

About GMRx2
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.


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