Novel proprietary low-dose, single-pill triple combination, GMRx2, is in late-stage development with global Phase III trials underway
Single-pill triple combination outperformed standard treatments without additional adverse effects in earlier clinical research
VERONICA-Nigeria trial aims for more than 80% blood pressure control while improving cost-effectiveness in treating hypertension, providing a potential valuable tool to address the growing burden of hypertension in Africa
London, UK, 7 Sept 2022 – 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 novel single-pill, triple combination candidate, GMRx2, is being used in the VERONICA-Nigeria trial as a novel treatment for hypertension. The trial commenced in August 2022 and 50 patients have already been enrolled.
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 aim of the VERONICA-Nigeria trial is to investigate whether a novel strategy (a single-pill, triple combination [GMRx2]-based treatment protocol) compared to the Nigeria hypertension treatment protocol for primary care use is effective, safe, and feasible to implement for improving blood pressure control in Nigeria whilst also improving cost-effectiveness.
The trial is funded through a programme grant from the National Health and Medical Research Council of Australia to The George Institute for Global Health. The plan is to expand into a larger trial involving thousands of patients across several other countries in Africa.
Should the novel strategy prove to be superior and more cost-effective than usual care, there is significant potential for it to be widely implemented in Sub-Saharan Africa as a low-cost, simple, and sustainable treatment option for healthcare services and patients.
The study has been named VERONICA in tribute to experienced South African clinical trial coordinator Veronica Francis, of the University of Cape Town, who was to manage the large trial but died in 2020 from complications of COVID-19.
High blood pressure is a major and growing cause of disease burden in Sub-Saharan Africa and, by 2030, it is projected that over 215 million Africans will have hypertension1. Currently, only 7% of patients in the region have their blood pressure under control2. In African populations, hypertension often occurs at younger ages, and is associated with more severe blood pressure levels, organ damage and a higher incidence of stroke, heart disease, kidney disease and mortality than observed in other populations3.
Associate Professor Dike Ojji, Cardiologist at University of Abuja, Nigeria, and local principal investigator of the VERONICA-Nigeria trial, said: “Poor adherence and limited access to quality and affordable medications are major roadblocks to bringing good blood pressure control to patients in Africa. This trial could lead to a low-cost, efficacious treatment paradigm that could improve the lives of millions of Africans while reducing the logistical and economic burden of treating hypertension in the region. Single-pill combinations are easier to take and to transport, which has the potential to improve adherence and make treatment more accessible for patients who need them.”
Professor Anthony Rodgers, Chief Scientific Officer of George Medicines, said: “The VERONICA trial builds on the TRIUMPH (Triple Pill vs Usual Care Management for Patients with Mild-to Moderate Hypertension) study conducted by The George Institute for Global Health in Sri Lanka, which found that therapy based on a low-dose, single-pill, triple combination, achieved 70% blood pressure control vs 55% with usual care provided by hospital physicians, without an increase in withdrawals due to side effects.4”
Professor Abdul Salam, The George Institute for Global Health, India, said: “We are delighted to be working with our colleagues in Nigeria to learn more about this triple combination approach and its potential to improve efficacy and patient adherence to blood pressure therapy.”
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, single-pill 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.
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- Adeloye D, Basquill C. Estimating the prevalence and awareness rates of hypertension in Africa: a systematic analysis. PLoS One 2014; 9(8): e104300
- Ataklte F, Erqou S, Kaptoge S, Taye B, Echouffo-Tcheugui JB, Kengne AP. Burden of undiagnosed hypertension in sub-saharan Africa: a systematic review and meta-analysis. Hypertension 2015; 65(2): 291-8
- Schutte AE, Botha S, Fourie CMT, et al. Recent advances in understanding hypertension development in sub-Saharan Africa. J Hum Hypertens 2017; 31(8): 491-500
- 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
Stefan König, Chief Executive Officer
Consilium Strategic Communications
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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 (NCDs) with patented, innovative, multi-mechanism combinations of existing medicines given at ultra-low doses.
Combining best-in-class molecules from existing medicines in novel low-dose formulations, George Medicines is developing innovative and proprietary treatments that are more efficacious, safer and accessible than currently available treatment options. These single-pill, multi-mechanism combinations offer the potential to bring significant improvements in clinical outcomes and therapy adherence in patients with NCDs, including hypertension, diabetes and other common cardiometabolic disorders, each of which remain the leading causes of premature death and disability worldwide.
The Company is building a strong and diversified pipeline of patented, single-pill, multi-mechanism combination therapies. Its lead candidate, GMRx2, is in Phase III development for the initial treatment of hypertension and under investigation for the prevention of recurrent intracerebral haemorrhage (the most severe type of stroke).
George Medicines is a spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia’s leading life sciences venture capital firm, supported by the Australian Government. For more information, please visit www.george-medicines.com.
Hypertension is a serious medical condition that significantly increases the risk of heart attack, stroke and kidney disease, among other issues. According to the World Health Organization, 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.
GMRx2 is a single pill, triple combination that 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.
Two Phase III trials are underway investigating the efficacy and safety of GMRx2 as a first-line treatment for hypertension:
- An international, multi-center, randomised, double blind, active controlled, parallel group study, evaluating the efficacy and safety of GMRx2 in patients with hypertension compared to dual combinations of the same components. The trial’s primary outcome measure is the change in home systolic blood pressure (SBP) from baseline to week 12. The trial is enrolling 1,500 patients across sites in seven countries, including the US, UK and Australia (NCT04518293).
- An international, multi-center, randomised, double blind, placebo controlled, parallel group study in 250 patients across 2 countries (US, Australia), evaluating the safety and efficacy of GMRx2 in patients with hypertension compared to placebo. The primary outcome measure of this trial is the difference in change in home SBP from baseline to Week 4 (NCT04518306).
GMRx2 is also being studied in an investigator-initiated study by The George Institute for Global Health. TRIDENT (Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial) is investigating the effectiveness of more intensive blood pressure-lowering treatment following an intracerebral haemorrhage (ICH) – a stroke caused by ruptured blood vessels in the brain – to prevent recurrent serious cardiovascular events such as stroke.
Acute ICH accounts for at least 10 per cent of the 20 million new strokes in the world each year and ICH survivors are at high risk of recurrent stroke and other cardiovascular events. While numerous studies have proven the benefit of stroke survivors reducing their risk of recurrent stroke through taking blood pressure-lowering medicines, many are either not receiving any blood pressure-lowering medication or they are receiving inadequate control.
TRIDENT is recruiting 4,200 patients with ICH from approximately 150 sites around the world. Learn more about the study here.