The Lancet publishes Phase III trial results of new triple combination hypertension pill

George Medicines, a late-stage biopharmaceutical company, has announced the publication of results from a pivotal Phase III clinical trial of their novel triple combination pill, GMRx2, in The Lancet. The trial highlights a significant reduction in blood pressure and improved control rates compared to traditional dual therapy, with good patient tolerability and no increase in adverse event-related withdrawals. This aligns with the latest European Society of Cardiology guidelines recommending combination therapies for hypertension.

The proprietary combination pill, GMRx2, includes three best-in-class medicines: telmisartan, amlodipine, and indapamide. It is developed in three dosage forms: triple quarter-dose, triple half-dose, and triple standard-dose. These were compared against dual combinations in treating hypertension, including for initial treatment. The multi-mechanism approach of the triple combination aims to optimize efficacy and safety while enhancing patient adherence.

This international trial, conducted in seven countries, met all primary efficacy and safety endpoints. GMRx2 was more effective than dual therapies in reducing both home- and clinic-measured blood pressure. The half-dose form achieved 63% clinic blood pressure control under 140/90 mmHg, which rose to 74% with the standard-dose form. These results were superior to all three dual combinations at standard-dose, which ranged from 53-61%. Furthermore, the triple combination reached 56% control rates against more stringent blood pressure targets of under 130/80 mmHg, outperforming the dual combinations, which ranged from 33-44%. Importantly, the trial reported good tolerability with no increase in withdrawals due to adverse events.

The trial's findings align with updated European Society of Cardiology guidelines, which recommend lower blood pressure thresholds for starting treatment and greater use of combination therapies, progressing from dual low-dose to triple low-dose therapy. Dr. Paul Whelton, Chair of the trial’s steering committee, emphasized the significance of these results, noting that the trial demonstrated GMRx2’s superior blood pressure control compared to dual therapies while maintaining an excellent safety profile. These results are particularly meaningful as they align with the latest guideline recommendations, potentially addressing the need for more effective and tolerable treatment options for patients who are not well-controlled on current therapies.

Dr. Anthony Rodgers, Chief Medical Officer of George Medicines, stated that the findings provide robust evidence for GMRx2’s potential to transform hypertension management. The superior efficacy and good tolerability of the triple combination therapy address critical challenges in current treatment approaches and support recent guideline recommendations. Subject to regulatory approval, GMRx2 could significantly impact global hypertension management and improve patient outcomes.

These results, along with data from other recent trials, including the VERONICA trial in Nigeria and a placebo-controlled Phase III study published in the Journal of the American College of Cardiology, provide comprehensive evidence supporting GMRx2’s efficacy and safety across various patient populations and dosing regimens.

In August 2024, George Medicines submitted a New Drug Application (NDA) for GMRx2 to the US Food and Drug Administration (FDA). Data from the clinical development program will support additional global regulatory filings.

George Medicines, an independent spin-out from The George Institute for Global Health, focuses on addressing significant unmet needs in cardiometabolic disease treatment. Backed by George Health and Brandon Capital, the company is committed to developing innovative and proprietary treatments that are more efficacious, safer, and accessible. Their lead candidate, GMRx2, has completed a Phase III development program for hypertension treatment and is undergoing a global trial focused on preventing recurrent intracerebral hemorrhage, a severe type of stroke.

The company combines best-in-class molecules from existing medicines in novel low-dose formulations to improve clinical outcomes and therapy adherence in patients with cardiometabolic disorders, including hypertension and diabetes, which remain leading causes of premature death and disability worldwide.