George Medicines submits New Drug Application to FDA for innovative low-dose hypertension treatment after successful Phase III trials

George Medicines has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for GMRx2, a novel triple combination drug intended for the treatment of hypertension. GMRx2 integrates three well-established medications—telmisartan, amlodipine, and indapamide—into a single low-dose pill. The NDA is based on the successful completion of two Phase III clinical trials that met all primary efficacy and safety endpoints.

Hypertension affects nearly half of the adult population in the US, yet only about a quarter of these individuals have their condition under control. This leaves over 70 million Americans with unmanaged high blood pressure, a significant risk factor for severe health issues such as heart attacks, strokes, and kidney failure. The current treatment approaches are often suboptimal, leading to poor patient outcomes.

Mark Mallon, CEO of George Medicines, emphasized the critical need for a new approach to hypertension treatment. "Hypertension remains a leading cause of death and disability. GMRx2's ability to provide rapid and effective blood pressure control with a favorable tolerability profile presents a transformative opportunity," he said.

The company's two Phase III studies were rigorous and comprehensive. The first study lasted four weeks and included 295 participants who received either GMRx2 or a placebo. The second study began with a four-week active period where 2,244 participants received GMRx2. This was followed by a 12-week randomized period in which 1,385 participants continued with GMRx2 or one of the three dual-drug combinations. Both studies focused on changes in home systolic blood pressure and monitored withdrawals due to adverse events as primary efficacy and safety endpoints.

George Medicines plans to publish the results of these studies by the end of the year. The development of GMRx2 drew on earlier research by The George Institute for Global Health, particularly the TRIUMPH trial in Sri Lanka. This earlier research demonstrated that a low-dose, single-pill triple combination significantly improved hypertension management compared to standard care.

The Surgeon General’s Call to Action to Control Hypertension in 2020 underscored the limitations and complexity of existing hypertension treatment pathways. Many patients do not achieve adequate blood pressure control due to insufficient therapy or failure to adhere to prescribed treatments. Major treatment guidelines recommend fixed-dose combination therapies for most hypertension patients, but in practice, many newly diagnosed patients still receive monotherapy.

GMRx2’s design aims to address these issues by combining the benefits of three different mechanisms of action into a single pill, thereby enhancing efficacy while minimizing side effects associated with higher doses of individual drugs. This approach not only improves blood pressure control but also enhances patient compliance and long-term adherence to treatment.

George Medicines is dedicated to addressing unmet needs in cardiometabolic diseases through innovative treatment combinations. The company is a spin-out from The George Institute for Global Health, known for its focus on global health inequity. GMRx2 represents the company's lead candidate, and its successful development could herald a new era in the management of hypertension, particularly in markets like the US, which is valued at $12 billion, and potentially worldwide, including low- and middle-income countries heavily burdened by hypertension.

By integrating best-in-class molecules into novel low-dose formulations, George Medicines aims to provide treatments that are more effective, safer, and more accessible. The company’s innovative approach offers significant potential to improve clinical outcomes and enhance adherence to therapy in patients suffering from cardiometabolic disorders.