George Medicines, a late-stage drug development company focused on providing innovative and accessible medicines for the world’s leading causes of death and a sister company to George Clinical, has initiated two Phase III trials investigating its proprietary triple combination candidate, GMRx2, as a first-line treatment for hypertension.
Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients and a previous trial indicated triple low-dose combination therapy is statistically and clinically superior to standard of care achieving better blood pressure control without increasing serious adverse effects. GMRx2 is a single pill triple combination in novel and proprietary dosage strengths containing telmisartan, amlodipine and indapamide, targeted for first line therapy to control hypertension.
George Medicines, a venture-backed spin-out company from The George Institute for Global Health, one of the world’s leading independent medical research institutes, is using its deep insights from academic research coupled with drug development and formulation expertise to combine best-in-class existing treatments in novel, fixed, ultra-low-dose combinations. These are intended to provide the optimal balance of high efficacy and improved safety, with potential for significant improvements in clinical outcomes and long-term adherence to treatment.
Chief Scientific Officer of George Medicines, Dr. Anthony Rogers said: “We are very pleased to be starting these two Phase III trials. High blood pressure is a leading cause of preventable morbidity and mortality globally and most people who are treated remain uncontrolled. Novel, low-dose combinations have great potential to substantially increase efficacy and improve adherence, while minimizing adverse effects. George Medicines has recognized this and developed a unique, three component, single-pill combination, GMRx2, with the potential for superior efficacy, safety, adherence and access, beyond currently available treatment options.”
Hypertension is a major preventable risk factor for heart disease, stroke, kidney failure and heart failure, leading causes of mortality and morbidity in the USA. More than 100 million US adults have hypertension and only 1 in 4 have adequately controlled blood pressure – tens of millions need to start treatment, and tens of millions more need better treatment. Globally, over a billion people worldwide have hypertension, with two-thirds living in low- and middle-income countries. Fewer than one in five people with hypertension have the problem under control.
The Phase III trials follow successful earlier trials of a low dose triple combination which significantly outperformed traditional high blood pressure treatments without additional side effects. In those trials 70% of patients receiving the combination reached their blood pressure target compared to just over half on their existing therapy. If successful in Phase III trials, GMRx2 could be available for patients by 2023, subject to regulatory approval by the US Food and Drug Administration (FDA).
The first Phase III trial is an international, multi-center, randomized, double blind, active controlled, parallel group study, evaluating the safety and efficacy of GMRx2 in patients with high blood pressure compared to dual combinations of the same components. The primary outcome measure of the trial will be change in home systolic blood pressure (SBP) from baseline to week 12. The trial will enroll 1,500 patients and will be conducted across sites in seven countries, including the US and Australia.
A second Phase III trial with 250 patients is investigating the efficacy and safety of GMRx2 compared to placebo for the treatment of mild hypertension. The primary outcome measure of this trial will be the difference in change in home SBP from baseline to Week 4.
Dr. Paul K. Whelton, MB, MD, MSc, FAHA, Show Chwan Chair in Global Public Health, Tulane University, and President-elect, World Hypertension League said: “Following the US Surgeon General’s Call to Action to Control Hypertension announced at the end of last year it is very good news that these two trials evaluating GMRx2 as a treatment for hypertension have commenced. Control of hypertension is a major unmet need, brought into more focus by COVID-19, to which patients with underlying conditions are most vulnerable. Trials such as those being conducted by George Medicines have the potential to help the millions of people worldwide with hypertension to live longer and healthier lives by enabling the provision of simple, affordable, effective and accessible medicines. If successful, these trials may have the potential to change the treatment paradigm of 1st line hypertension.”