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.
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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/news-room/fact-sheets/detail/hypertension
- 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 https://www.ahajournals.org/doi/10.1161/HYP.0000000000000065; WHO Guideline for the pharmacological treatment of hypertension in adults https://iris.who.int/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
COMTEX_458108311/2471/2024-09-24T07:00:06