George Medicines' GMRx2, a novel triple combination pill containing telmisartan, amlodipine, and indapamide, has demonstrated superior efficacy in reducing blood pressure compared to dual therapies in a Phase III clinical trial. The results, published in The Lancet, highlight the potential of GMRx2 to improve hypertension management and patient outcomes.
The international trial, conducted across seven countries, involved 1,385 patients and compared GMRx2 in standard- and half-dose forms against dual combinations of its component drugs. The primary efficacy outcome was the difference in home blood pressure change from randomization to week 12.
Efficacy and Safety Endpoints
GMRx2 met all primary efficacy and safety endpoints, demonstrating significantly greater reductions in both home- and clinic-measured blood pressure compared to dual therapies. The half-dose of GMRx2 achieved a 63% clinic BP control rate (<140/90 mmHg), which increased to 74% with the standard dose at the end of follow-up. This was superior to all three dual combinations at standard doses, which ranged from 53% to 61%.
When assessed against more stringent BP control rates (<130/80 mmHg), the GMRx2 standard dose achieved a 56% control rate, again clinically and statistically superior to all three dual combinations (33-44%). Tolerability was reported as good, with no increase in withdrawal from treatment due to adverse events.
Expert Commentary
Dr. Paul Whelton, Chair of the trial’s steering committee, noted, "This trial, conducted across seven countries and diverse populations, demonstrates that GMRx2 provides significantly better blood pressure control compared to dual combinations, while maintaining an excellent safety profile. The findings are particularly noteworthy as they show efficacy at lower blood pressure levels, aligning with the latest guideline recommendations."
Dr. Anthony Rodgers, Chief Medical Officer of George Medicines, added, "These findings, now published in The Lancet, provide robust evidence for the potential of GMRx2 to transform hypertension management. The superior efficacy of this triple combination therapy compared to dual combinations, coupled with its good tolerability, addresses key challenges in current hypertension treatment approaches and directly supports recent guideline recommendations."
Alignment with Current Guidelines
This treatment approach aligns with the recently updated European Society of Cardiology (ESC) guidelines for hypertension management, which recommend lower blood pressure levels to begin treatment among those at raised risk and greater use of combination therapy, starting off with dual low-dose followed by a triple low-dose therapy.
Regulatory Submission
George Medicines announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for GMRx2 in August 2024. If approved, GMRx2 would be the first triple combination approved for the initial treatment of hypertension.
About Hypertension
Globally, more than one billion adults have hypertension. Many patients do not achieve sufficient blood pressure control due to inadequate therapy, incorrect medicine combinations, or poor adherence. Major treatment guidelines recommend fixed-dose combination therapy for most hypertension patients, including first-line treatment.
