George Medicines has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for GMRx2, a single-pill, triple-combination therapy designed to treat hypertension. The application is based on the achievement of primary efficacy and safety endpoints in two Phase III studies. These studies evaluated GMRx2, which combines low doses of telmisartan, amlodipine, and indapamide, against dual therapy and placebo.
Clinical Trial Data Supporting NDA
The Phase III studies supporting the NDA included a 4-week, placebo-controlled trial with 295 subjects and a 16-week active-controlled trial involving 2,244 subjects. The latter study included a 4-week run-in period where all subjects received GMRx2, followed by a 12-week randomized period comparing GMRx2 to its component two-drug combinations. The primary efficacy endpoint in both studies was the change in home systolic blood pressure (SBP) from baseline, while the primary safety endpoint was the difference in withdrawals due to adverse events. Detailed results from these trials are expected to be published by the end of the year.
Addressing Unmet Needs in Hypertension Management
Hypertension affects nearly one in two adults in the US, yet only about 25% have their condition under control. Mark Mallon, CEO of George Medicines, emphasized the need for a new approach, stating that over 70 million patients in the US lack adequate blood pressure control, often due to suboptimal treatment. Current guidelines recommend fixed-dose combination therapy for most hypertension patients, but monotherapy is still frequently prescribed, despite evidence suggesting that most patients require multiple medications to achieve adequate blood pressure control.
Potential Benefits of GMRx2
GMRx2 is designed to deliver rapid and effective blood pressure control with a favorable tolerability profile. The multi-mechanism approach, using lower doses than traditional therapies, aims to provide synergistic efficacy benefits while maintaining tolerability. This may lead to improved patient adherence and better overall management of hypertension. The company aims to secure commercialization partners to bring GMRx2 to patients, initially targeting the $12 billion US hypertension market and then expanding globally, including to low- and middle-income countries with a high hypertension burden.
About George Medicines
George Medicines is a spin-out company from The George Institute for Global Health. The company focuses on developing low-dose, single-pill combinations of existing medicines to address non-communicable cardiometabolic diseases. In addition to GMRx2, George Medicines is developing GMRx4 for type 2 diabetes, and has ongoing research programs in heart failure, coronary heart disease, and chronic kidney disease.
