ESC24: George Medicines Showcases Positive Results from Two Late-Stage Hypertension Triple Combo Studies

George Medicines recently shared promising results from two pivotal Phase III clinical trials evaluating its innovative triple combination therapy for hypertension, known as GMRx2. This therapy combines telmisartan, amlodipine, and indapamide in various dosages: ultra-low, low, and standard. The findings were unveiled at the European Society of Cardiology (ESC) Congress.

Anthony Rodgers, the chief medical officer of George Medicines, emphasized the pressing global issue of hypertension, stating that the potential impact of a safe, low-dose, triple therapy for early hypertension treatment is significant.

In the first study, GMRx2 was tested in standard and half-dose forms against dual combinations of its component medications. The primary efficacy measure was the change in home-measured blood pressure (BP) from the start of the study to week 12. The results demonstrated that GMRx2 significantly outperformed the dual therapies by lowering both home- and clinic-measured BP and improving BP control rates. Specifically, the standard-dose regimen achieved a 74% clinic BP control rate compared to the 53% to 61% range seen with dual combinations. Additionally, GMRx2 showed good tolerability with no increase in treatment withdrawals due to adverse events. The trial included patients with "considerably lower" baseline BP levels than previous studies, aligning with recent guidelines recommending lower BP targets.

In the second, smaller Phase III study, low and ultra-low doses of GMRx2 were compared with a placebo, focusing on BP changes from the start to week 4. The findings revealed that GMRx2 significantly improved both home- and clinic-measured BP and control rates, while also being well-tolerated.

George Medicines also spotlighted GMRx2's potential in Africa through the VERONICA study, which assessed the low-dose form against standard care in Black African adults with uncontrolled hypertension. This trial showed that GMRx2 led to substantial reductions in both home- and clinic-measured BP, with over 80% BP control at one month, sustained through six months. The comparator group achieved a 70% BP control rate at six months. The triple therapy was well-tolerated, with no withdrawals due to adverse events and only mild cases of hypokalaemia.

Last month, George Medicines submitted a marketing application to the FDA for GMRx2 to treat hypertension, following the successful Phase III program. Chief executive Mark Mallon, who recently took charge of the company, noted that "subject to its review by regulators, GMRx2 would be the first medicine approved for the initial treatment of hypertension in over a decade."

George Medicines is an independent spin-off from The George Institute for Global Health, supported by George Health, the institute's commercial arm, and venture capitalist Brandon Capital.

These findings underscore the potential of GMRx2 as an effective, early treatment option for hypertension, which could address a significant global health burden.