A New Drug Application for GMRx2, a novel low dose triple combination pill for the treatment of hypertension, has been submitted to the US Food and Drug Administration (FDA) by George Medicines following many years of research by The George Institute.
Published in 2018, the Institute's landmark TRIUMPH trial conducted in Sri Lanka found that a significantly greater proportion of patients with mild to moderate hypertension treated with a low dose, single-pill, triple combination achieved target blood pressure versus those receiving usual care.
Results from the 300-patient VERONICA trial taking place in Nigeria are expected to be published later this year and are anticipated to show positive outcomes.
According to the World Health Organization, two-thirds of the estimated 1.28 billion adults aged 30-79 with hypertension live in low- and middle-income countries, with many undiagnosed and untreated. Limited access to essential medicines for treating chronic diseases is a major challenge in these countries and it is hoped that GMRx2 will help to address this unmet need.
George Medicines is a venture-backed spin-out company initially established to commercialise the research of The George Institute for Global Health. It uses the research base and scientific expertise of The George Institute to pursue the late-stage development of single-pill, multi-mechanism, combination therapies.
