George Medicines completes recruitment of second Phase III hypertension trial investigating novel single-pill triple combination candidate GMRx2
– More than 250 patients enrolled in placebo-controlled trial evaluating efficacy and safety of GMRx2 as treatment for hypertension including first line therapy
– Novel, patent-protected low and ultra-low dose triple combinations of best-in-class treatments which are designed for optimal efficacy and safety, and to reach targeted blood pressure control across different patient types
– Topline safety and efficacy data from Phase III programme anticipated in Q4 2023
London, UK, 28 September 2023 – George Medicines, a late-stage drug development company transforming the management of cardiometabolic disease, today announced that all patients have been enrolled in its Phase III placebo-controlled trial evaluating the efficacy and safety of GMRx2, the Company’s lead pipeline candidate, as a treatment for hypertension including first-line therapy.
More than 250 patients have been enrolled in the trial, across five countries (Australia, Nigeria, Sri Lanka, UK and US) comparing GMRx2, the Company’s proprietary single-pill, multi-mechanism, triple combination of telmisartan, amlodipine and indapamide – three existing, best-in-class treatments – against placebo.
George Medicines has now completed recruitment of both pivotal Phase III trials. In July, the Company announced completion of enrollment of its Phase III active-controlled trial comparing GMRx2 with dual combinations of the same components. Topline safety and efficacy data from both trials is expected before the end of the year.
GMRx2, a novel, patent-protected low and ultra-low dose single pill combination, is being developed as a simple, go-to solution to reach targeted blood pressure control across different patient types. Globally, over a billion people worldwide have hypertension but fewer than one in five have the condition under control. Individually, antihypertensive medicines are only modestly effective in reducing blood pressure, even at high doses, and most patients require two or more to achieve blood pressure control.
Dr. Karl Roberts, Chief Operating Officer of George Medicines, said: “George Medicines’ mission is to extend and improve the lives of the millions of people suffering from non-communicable cardiometabolic diseases. The upcoming data readout for our Phase III asset, GMRx2, is a significant milestone in the development programme of this potentially transformative treatment option for hypertension, a condition which remains one of the world’s leading causes of death and disability.”
GMRx2 is designed for optimal efficacy and safety, with single pill daily dosing also providing an opportunity to improve adherence. The synergistic and additive effects of its multiple mechanisms, in low doses, have the potential to be effective in a broad patient population, for use in earlier lines of treatment, and would avoid traditional escalation of testing and titrating multiple medicines.
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George Medicines is a late-stage drug development company with a mission to extend and improve the lives of millions of people suffering from non-communicable cardiometabolic diseases with patent-protected, low dose single-pills combinations of existing best-in-class medicines.
These single-pill, multi-mechanism combinations offer the potential to bring significant improvements in clinical outcomes and therapy adherence in patients with non-communicable diseases (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 with two lead product candidates in late-stage development. GMRx2, is in Phase III development for the treatment of hypertension including first line therapy and for the prevention of recurrent intracerebral haemorrhage (the most severe type of stroke); GMRx4 is in Phase II development for the treatment of type 2 diabetes. Further research programmes are underway in heart failure, coronary heart disease and chronic kidney disease.
George Medicines is a spin-out company from The George Institute for Global Health, one of the world’s leading health research institutes for chronic disease. The Company is backed by George Health, the commercial arm of The George Institute, Brandon Capital, Australia’s leading life sciences venture capital firm supported by the Australian Government, BUPA and Federation Asset Management. For more information, please visit www.george-medicines.com.
ICR Consilium
David Daley, Lindsey Neville, Isabelle Abdou georgemedicines@consilium-comms.com
Tel: +44 (0) 203 709 5700
