George Medicines completes recruitment of first Phase III hypertension trial investigating novel single-pill triple combination candidate GMRx2
- All patients enrolled in active–controlled trial evaluating efficacy and safety of GMRx2 as treatment for hypertension including first line therapy
- Novel, patent-protected low and ultra-low dose formulations of GMRx2 are designed for optimal efficacy and safety, and to reach targeted blood pressure control across different patient types
- Second trial in Phase III programme, comparing GMRx2 against placebo, expands into new geographies, with both trials on track to report topline safety and efficacy data in Q4 2023
London, UK, 12 July 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 active-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 1,300 patients have been enrolled in the trial, across seven countries including the US, UK and Australia, comparing GMRx2, the Company’s proprietary single-pill, multi-mechanism, triple combination of telmisartan, amlodipine and indapamide – three existing, best-in-class treatments – with dual combinations of the same components.
George Medicines’ mission is to extend and improve the lives of the millions of people suffering from non-communicable cardiometabolic diseases – the world’s leading causes of death and disability, including hypertension and diabetes. Its patent-protected, single-pill, multi-mechanism combinations of best-in-class, existing treatments in low and ultra-low doses, have the potential to reduce the impact of these diseases on patients, families, health systems and economies across the globe.
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.
GMRx2 is formulated in novel, patent-protected low and ultra-low doses, to be a simple, go-to solution to reach targeted blood pressure control across different patient types. Designed for optimal efficacy and safety, 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. Daily dosing with just one pill also provides an opportunity to improve adherence.
Dr. Karl Roberts, Chief Operating Officer of George Medicines, said: “The progress of this Phase III programme is a huge testament to the dedication of the team and our partners working to bring GMRx2 to patients. There is an ambitious vision behind this combination candidate, to improve blood pressure control for patients globally, more quickly and without the tolerability and adherence challenges associated with currently available treatment options. Ahead of the programme’s data readout anticipated later this year, we’re continuing our discussions with potential commercial partners for GMRx2 who share our belief in its potential and recognise the opportunity we have to transform how hypertension can be treated.”
The Company also recently expanded its second trial in the GMRx2 Phase III programme, a placebo-controlled trial among 250 patients, into the UK, Nigeria and Sri Lanka. Already active in the US and Australia, in collaboration with global clinical research organisation George Clinical, this second trial is now actively recruiting patients further in Europe and into Africa and South Asia, in collaboration with the Imperial Clinical Trials Unit (ICTU) at Imperial College London and RemediumOne in Sri Lanka.
About George Medicines
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.
Consilium Strategic Communications
David Daley, Lindsey Neville, Isabelle Abdou [email protected]
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