We are building a strong and diversified proprietary pipeline of innovative, single-pill, multi-mechanism combination therapies in novel and unique dosage strengths, targeting some of the leading causes of death in both developed and developing countries, including hypertension, diabetes and other common cardiometabolic disorders. Our most advanced candidate in Phase III development, GMRx2, is a single-pill, triple-combination, in novel and proprietary dosage strengths, for the first-line treatment of hypertension and the prevention of recurrent intracerebral haemorrhage (the most severe type of stroke).
A pipeline to deliver major patient impact
At George Medicines, we are focused on developing late-stage drugs to improve upon existing treatments of non-communicable diseases through innovative, sustainable, and more patient-friendly methods.
Our innovative pipeline is targeting some of the world’s leading causes of death, including hypertension, recurrent intracerebral haemorrhage (stroke), cardiovascular disease and type 2 diabetes.
By developing best-in-class, existing treatments in innovative, single-pill, multi-mechanism combinations, George Medicines is building a pipeline of future treatments with the potential to be more efficacious, safer, and more affordable than the current alternatives.
We understand the financial burden associated with current medications and the resultant impact on accessibility to regions worldwide. With all our combination therapies in development, accessibility is a core focus regardless of the region.
The George Medicines Pipeline
GMRx2 is a single-pill, multi-mechanism, triple combination containing the commonly used hypertension medicines telmisartan, amlodipine and indapamide, in novel and proprietary dosage strengths.
Through this innovative combination we aim to tackle the growing issue of hypertension, one of the leading causes of cardiovascular disease and morbidity, while improving accessibility in key markets across the globe1,2. GMRx2 has the potential to provide an optimal balance of increased efficacy and patient adherence and reduced side effects compared with current treatments and thereby potentially aiding millions of patients globally.
Two Phase III trials are underway investigating the efficacy and safety of GMRx2 as a first-line treatment for hypertension:
- An international, multi-center, randomised, double blind, active controlled, parallel group study, evaluating the efficacy and safety of GMRx2 in patients with hypertension compared to dual combinations of the same components. The trial’s primary outcome measure is the change in home systolic blood pressure (SBP) from baseline to week 12. The trial is enrolling 1,500 patients across sites in seven countries, including the US, UK and Australia (NCT04518293).
- An international, multi-center, randomised, double blind, placebo controlled, parallel group study among 250 patients in the US and Australia, evaluating the safety and efficacy of GMRx2 in patients with hypertension compared to placebo. The primary outcome measure of this trial is the difference in change in home SBP from baseline to Week 4 (NCT04518306).
GMRx2 is also being studied in an investigator-initiated study by The George Institute for Global Health. TRIDENT (Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial) is investigating the effectiveness of more intensive blood pressure-lowering treatment following an intracerebral haemorrhage (ICH) – a stroke caused by ruptured blood vessels in the brain – to prevent recurrent serious cardiovascular events such as stroke.
Acute ICH accounts for at least 10 per cent of the 20 million new strokes in the world each year and ICH survivors are at high risk of recurrent stroke and other cardiovascular events. While numerous studies have proven the benefit of stroke survivors reducing their risk of recurrent stroke through taking blood pressure-lowering medicines, many are either not receiving any blood pressure-lowering medication or they are receiving inadequate control.
TRIDENT is recruiting 4,200 patients with ICH from approximately 150 sites around the world. Learn more about the study here.
GMRx4 is a single pill, triple combination in development as a first-line treatment for type 2 diabetes, containing three existing best-in-class drugs and formulated at an ultra-low dose: metformin XR 350mg, dapagliflozin 2.5mg and sitagliptin 17.5mg.
GMRx4 is being developed to provide a synergistic effect from the three drugs and, in an ultra-low-dose, single pill formulation, aims to be a more effective, simpler and safer treatment regimen than existing therapies for newly diagnosed patients.
Preclinical and Phase I data showed GMRx4 significantly reduced whole blood glucose levels in comparison to other combination approaches and significantly decreased HbA1c (%) as compared to other tested treatment combinations.
In July 2022 George Medicines announced the advancement of GMRx4 into Phase II development, supported by the award of a AUS$1.5 million grant from CUREator, Australia’s national biomedical incubator managed by Brandon BioCatalyst. Learn more here.
1Murray CJL, Aravkin AY, Zheng P, Abbafati C, Abbas KM, Abbasi-Kangevari M, et al. Global burden of 87 risk factors in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. The Lancet. 2020;396(10258):1223-49.
2The Blood Pressure Lowering Treatment Trialists’ Collaboration. Pharmacological blood pressure lowering for primary and secondary prevention of cardiovascular disease across different levels of blood pressure: an individual participant-level data meta-analysis. The Lancet. 2021;397(10285):1625-36.
3Chow CK, Teo KK, Rangarajan S, et al. Prevalence, awareness, treatment, and control of hypertension in rural and urban communities in high-, middle-, and low-income countries. JAMA. 2013;310(9):959-68.
4Fryar CD, Ostchega Y, Hales CM, Zhang G, Kruszon-Moran D. Hypertension prevalence and control among adults: United States, 2015–2016.
5Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. European Heart Journal. 2018:ehy339-ehy.