University of Abuja

London, UK 24 September 2024 – George Medicines, a late-stage, biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic disease, today announced the presentation of positive clinical trial results investigating GMRx2, its novel, multi-mechanism triple combination candidate for the treatment of hypertension, including initiation of treatment, at the recent 30th Congress of the International Society of Hypertension, held in Cartagena, Colombia, 19-22 September. GMRx2 contains best-in-class medicines, telmisartan, amlodipine and indapamide, in proprietary, triple quarter-dose (ultra-low dose), triple half-dose (low-dose) and triple standard-dose options. Designed for optimal efficacy, safety and adherence, GMRx2’s low-dose, multi-mechanism approach, delivers the synergistic efficacy benefits of a triple therapy while maintaining tolerability. Professor Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University, New Orleans, Louisiana, President of the World Hypertension League and Chair of the steering committee for the Phase III clinical trial program shared an overview of recent positive clinical data from three recent trials: George Medicines’ pivotal Phase III trial testing GMRx2 against dual combinations of its component drugs, which determined that GMRx2 was more effective than dual therapy, significantly reducing blood pressure (BP) and improving BP control rates, with both standard- and half-dose forms.A second Phase III trial, recently published in the Journal of the American College of Cardiology, comparing GMRx2 against a placebo pill, in which GMRx2 significantly improved BP and BP control rates, in both half- and quarter-doses.The VERONICA trial in Nigeria, led by Professor Dike Ojji at University of Abuja, funded by the National Health and Medical Research Council (NHMRC) of Australia, supported by The George Institute for Global Health and recently published in JAMA, which compared GMRx2-based treatment protocol with existing, standard care protocol and reported significant reductions in BP among those receiving GMRx2. In all trials, tolerability was good, with no increase in withdrawal from treatment due to adverse events. Mark Mallon, Chief Executive Officer of George Medicines, said: “We’re pleased that the clinical and global health significance of our research findings for GMRx2 are being shared with the international hypertension community. The continuing disease burden of hypertension is too big to ignore and with GMRx2 we have an opportunity to unlock better treatment for patients globally.” In August 2024 George Medicines announced its submission to the US Food and Drug Administration (FDA) of a New Drug Application (NDA) for GMRx2. Data from GMRx2’s clinical development program will support additional global regulatory filings. George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company’s GMRx2 development program built on earlier research by The George Institute, including the 700-patient TRIUMPH trial undertaken in Sri Lanka in 2016/17, which found that among patients with mild to moderate hypertension, treatment with a low-dose triple combination pill led to an increased proportion of patients achieving their target blood pressure goal versus usual care. Ends About hypertension (high blood pressure)Globally, more than one billion adults have hypertension1. Many diagnosed patients aren’t achieving sufficient blood pressure control because they are on inadequate therapy, aren’t receiving the right combination of medicines at the right doses or aren’t taking their treatment as prescribed or continuing their treatment in the long term. The major, globally recognized treatment guidelines4 recommend the use of fixed dose combination therapy for most patients with hypertension, including for first-line treatment and yet, in practice, newly diagnosed patients will often still be prescribed monotherapy treatment. This is despite a broad evidence base indicating that, individually, blood pressure medicines are only modestly effective at reducing blood pressure, even at high doses, and most patients will require two or more medicines to achieve control. As dosage of hypertension drugs is increased, so too are side effects, which can preclude the use of high doses for many patients. These side effect challenges, alongside the management of multiple hypertension medicines being taken together with treatments for other conditions, can significantly impact treatment compliance and adherence, including failure to take medications as prescribed and to persist on long-term therapy. About George Medicines George Medicines is a late-stage biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic diseases with innovative combinations of best-in-class existing treatments, designed for optimal efficacy and safety. Combining best-in-class molecules from existing medicines in novel low-dose formulations, George Medicines is developing innovative and proprietary treatments to be more efficacious, safer and accessible than currently available treatment options. These multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes and therapy adherence in patients with cardiometabolic disorders, including hypertension and diabetes, each of which remain the leading causes of premature death and disability worldwide. The Company’s lead candidate, GMRx2, has completed a Phase III development program for the treatment of hypertension, including first-line therapy, and a global trial focused on the prevention of recurrent intracerebral hemorrhage (the most severe type of stroke) is underway. George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. 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. For more information, please visit www.george-medicines.com. References World Health Organization Hypertension factsheet https://www-who-int.libproxy1.nus.edu.sg/news-room/fact-sheets/detail/hypertension2017 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 https://www-ahajournals-org.libproxy1.nus.edu.sg/doi/10.1161/HYP.0000000000000065; WHO Guideline for the pharmacological treatment of hypertension in adults https://iris-who-int.libproxy1.nus.edu.sg/bitstream/handle/10665/344424/9789240033986-eng.pdf; 2024 ESC Guidelines for the management of elevated blood pressure and hypertension https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Elevated-Blood-Pressure-and-Hypertension Media contacts ICR Consilium David Daley, Lindsey Neville, Isabelle Abdou georgemedicines@consilium-comms.com; Tel: +44 (0) 203 709 5700

TUESDAY, Sept. 10, 2024 -- For Black African adults with uncontrolled hypertension , a low-dose triple-pill protocol achieves better blood pressure lowering and control than standard care, according to a study published online Aug. 31 in the Journal of the American Medical Association to coincide with the European Society of Cardiology Congress 2024, held from Aug. 30 to Sept. 2 in London. Dike B. Ojji, Ph.D., from the University of Abuja in Nigeria, and colleagues compared the effectiveness and safety of a novel low-dose triple-pill protocol with a standard-care protocol for lowering blood pressure in a trial conducted in public hospital-based family medicine clinics in Nigeria. Black African adults with uncontrolled hypertension who were untreated or receiving a single blood pressure-lowering drug were randomly assigned to low-dose triple-pill or standard-care protocols. The triple-pill protocol involved a novel combination of telmisartan, amlodipine, and indapamide in triple one-quarter, one-half, and standard doses; the standard-care protocol started with amlodipine. The researchers found that at month 6, mean home systolic blood pressure was on average 31 and 26 mm Hg lower in the triple-pill and standard-care protocols, respectively. At month 6, in the triple-pill and standard-care protocols, clinical blood pressure control was 82 and 72 percent, respectively, and home blood pressure control was 62 versus 28 percent, respectively. None of the participants discontinued treatment due to adverse events. "The results demonstrate that the World Health Organization goal to achieve greater than 80 percent blood pressure control in those treated for hypertension is possible in low-income settings," the authors write. Several authors disclosed ties to industry.

WEDNESDAY, Sept. 4, 2024 -- An experimental three-in-one blood pressure pill works better than layering on meds one at a time, a new clinical trial shows. After a month on the combo pill, 81% of patients had their blood pressure under control compared with 55% of patients receiving standard care, researchers report. “The triple pill still produced clinically meaningful reductions in blood pressure compared to standard care, even when standard care closely followed current guidelines and involved more clinic visits,” said lead investigator Dr. Dike Ojji , head of the Cardiovascular Research Unit at the University of Abuja in Nigeria. “In low-income countries, fewer than one in four treated people achieve blood pressure control, and in high-income settings it is only between 50% and 70%, so to see rates of over 80% in just one month is impressive,” Ojji added. The GMRx2 pill, which was developed by the pharmaceutical company George Medicines, contains the blood pressure meds telmisartan , amlodipine and indapamide . It’s taken once daily. The company is part of the George Institute for Global Health . Researchers compared people taking the combo pill to those receiving standard treatment for high blood pressure, which involves starting off with one drug and then adding on others. Systolic blood pressure was 31 points lower in the combo pill group after six months of treatment, compared to 26 points lower with standard care, results showed. The five-point systolic difference is equal to a 10% reduction in stroke, heart attack and heart failure risk between the two groups, researchers said in a George Institute news release. It’s estimated more than a billion people worldwide have high blood pressure, which accounts for nearly 11 million deaths each year, researchers said in background notes. George Medicines has submitted the combo drug to the U.S. Food and Drug Administration for approval. The trial results were presented Saturday at the European Society of Cardiology’s annual meeting in London and published simultaneously in the Journal of the American Medical Association . Positive data from two other trials of the combo pill were also presented at the meeting. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.