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George Medicines Provides a Single Triple Tablet Combination Candidate for Hypertension in the VERONICA-Nigeria Trial
The new proprietary low-dose, single-tablet, and triple-dose combination, GMRx2, is in complex progression with ongoing phase III trials.
One-tablet triple blend outperformed remedies with no additional adverse effects in previous clinical research
The Veronica-Nigeria trial targets blood pressure of more than 80% while improving the cost-effectiveness of high blood pressure treatment, offering a valuable prospective tool to address the growing burden of high blood pressure in Africa
London, UK, 7 September 2022: George Medicines, an advanced-stage drug progression company whose aim is to offer available, cutting-edge medicines for the world’s leading causes of death, today announced that its new single-tablet triple combination candidate, GMRx2, is being used in the VERONICA-Nigeria trial as a new remedy for hypertension. The trial began in August 2022 and 50 patients have already been enrolled.
GMRx2 is George Medicine’s ultimate complex candidate for complex development. It is a triple blend of a single pill that contains low doses of commonly used high blood pressure medications, such as telmisartan, amlodipine, and indapamide.
The aim of the VERONICA-Nigeria trial is to investigate whether a new strategy (a treatment protocol based on a single tablet and a triple mixture [GMRx2]) compared to Nigeria’s high blood pressure treatment protocol for use in number one care is effective, safe and feasible to implement to improve blood pressure control in Nigeria while obtaining better cost-effectiveness.
The trial is funded through a grant from australia’s National Health and Medical Research Council program to the George Institute for Global Health. The plan is to expand into a larger trial involving thousands of patients in several African countries.
If the new strategy proves to be incredible and more cost-effective than the same previous care, there is a significant prospect that it will be widely implemented in sub-Saharan Africa as a sustainable, undeniable and low-cost remedy option for fitness facilities and patients.
The study named VERONICA after experienced South African clinical trial coordinator Veronica Francis of the University of Cape Town, who to administer the giant trial died in 2020 of COVID-19 headaches.
High blood pressure is a primary and developing cause of the burden of disease in sub-Saharan Africa and, by 2030, more than 215 million Africans are projected to suffer from high blood pressure1. Currently, only 7% of patients in the region have their blood Tension under control 2. In African populations, high blood pressure occurs at a younger age and is linked to more severe blood pressure levels, organ damage, and a higher incidence of stroke, heart disease, kidney disease, and mortality than in other populations. 3
Associate Professor Dike Ojji, a cardiologist at the University of Abuja, Nigeria, and local principal investigator of the VERONICA-Nigeria trial, said: “Poor adherence and limited access to affordable, quality medicines are the main barriers to bringing intelligent blood pressure control to patients in Africa. This test can lead to an effective and affordable treatment paradigm that can improve the lives of millions of Africans while reducing the logistical and economic burden of treating high blood pressure in the region. Single-tablet combinations are less difficult to take and carry, which has the potential to improve adherence and make the remedy more available to patients who want it.
Professor Anthony Rodgers, Chief Scientific Officer of George Medicines, said: “The VERONICA trial is based on the TRIUMPH (Triple Pill vs Usual Care Management for patients with mild to moderate hypertension) examination conducted through the George Institute for Global Health in Sri Lanka, which found that treatment discovered in a triple combination of a single low-dose tablet allowed for a blood pressure of 70% compared to 55% with same previous care provided by hospital doctors, with no dropouts due to side effects. “4
Professor Abdul Salam, from India’s George Institute for Global Health, said: “We are very pleased to be working with our Nigerian colleagues to receive more information about this combined triple technique and its perspective for improving patient efficacy and adherence to treatment. “remedy of blood pressure.
George Medicines, a venture-backed spin-off company of the George Institute for Global Health, one of the world’s leading independent medical study institutes, uses its deep wisdom from educational studies combined with progression expertise and drug formulas to combine the qualifications of remedies into new combinations of individual tablets. These are intended to provide an optimal balance between maximum efficacy and improved safety, with the prospect of significant innovations in clinical outcomes and long-term treatment adherence.
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references
Adeloye D, Basquill C. Estimating the prevalence of high blood pressure and awareness rates in Africa: a systematic analysis. PLoS One 2014; 9(8): e104300
Ataklte F, Erqou S, Kaptoge S, Taye B, Echouffo-Tcheugui JB, Kengne AP. Undiagnosed high blood pressure burden 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 the progression of high blood pressure in sub-Saharan Africa. J Hum Hypertens 2017; 31(8): 491-500
Triple combination of low-dose fixed antihypertensive drugs compared to 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 MedicinesStefan König, Ceo info@george-medicines. com
Consilium Strategic CommunicationsDavid Daley, Lindsey Neville, Isabelle AbdouTel: (0) 203 709 5700 georgemedicines@consilium-comms. com
About George’s Medications
George Medicines is an advanced-stage drug progression company that focuses on the control of noncommunicable diseases (NCDs) with proprietary, state-of-the-art, multi-mechanism combinations of existing drugs administered in ultra-low doses.
By combining best-in-class molecules of existing drugs into new low-dose formulations, George Medicines presents patented, cutting-edge remedies that are more effective, safer, and more available than the lately available remedy options. Combinations of multiple mechanisms offer the possibility of achieving significant innovations in clinical outcomes and remedying adherence in NCD patients, adding hypertension, diabetes and other common cardiometabolic disorders, which remain the leading causes of premature death and disability worldwide.
The company is building a strong and varied line of proprietary multi-mechanism combination therapies from a single tablet. Its lead candidate, GMRx2, is in Phase III progression for the initial treatment of high blood pressure and is being studied for the prevention of recurrent intracerebral hemorrhages. (the most severe type of stroke).
George Medicines is a spin-off of the George Institute for Global Health, one of the world’s leading medical studies institutes. The company is subsidized through George Health, the advertising arm of the George Institute, and Brandon Capital, Australia’s leading life sciences venture capital. firm, subsidized by the Australian government. For more information, visit www. george-medicines. com. About High Blood Pressure Hypertension is a serious disease that particularly increases the threat of central attack, stroke, and kidney disease, among other challenges. According to the World Health Organization, high blood pressure affects 1. 1 billion people worldwide, two-thirds of whom live in low- and middle-income countries. It is known as a “silent killer” because most people are not aware of the challenge unless they are tested. It is a leading cause of premature death.
About GMRx2GMRx2 is a unique and triple blend that has been developed in 3 dosage forms: 10 mg telmisartan, 1. 25 mg amlodipine and indapamide 0. 625 mg; telmisartan 20 mg, amlodipine 2. 5 mg and indapamide 1. 25 mg; and telmisartan 40 mg, amlodipine five mg and indapamide 2. 5 mg.
Two phase III trials are underway to investigate the efficacy and protection of GMRx2 as a first-line remedy for hypertension:
An international, multicenter, randomized, double-blind, controlled versus active, parallel-group study comparing the efficacy and protection of GMRx2 in patients with high blood pressure compared to dual combinations of the same components. The number one final results of the trial replace systolic blood pressure (SBP) at home between baseline and week 12. The trial is enrolling 1500 patients at sites in seven countries, in addition to the United States, the United Kingdom, and Australia (NCT04518293).
An international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in 250 patients in 2 countries (USA). In the US, Australia), which compared the protection and efficacy of GMRx2 in patients with high blood pressure compared to placebo. The number one end result of this trial is the difference in home SBP replacement between baseline and week four (NCT0four518306).
GMRx2 is also being studied in a study initiated by the researcher through the George Institute for Global Health. TRIDENT (Triple Cure Prevention of Recurrent Intracerebral Disease EveNts Trial) studies the effectiveness of more extensive hypotensive treatment after intracerebral hemorrhage (ICH), a stroke caused through the rupture of blood vessels in the brain, in preventing recurrent serious cardiovascular events, such as stroke.
Acute ICH accounts for at least 10% of the 20 million new strokes per international year and HIC survivors are at the greatest risk of recurrent strokes and other cardiovascular events. taking antihypertensive medications, many of them do not get any antihypertensive medication or are poorly controlled.
TRIDENT is enrolling 4200 patients with ICH at approximately 150 sites worldwide. Learn more here.