Single-Pill Triple Combination Sustains Year-Long Blood Pressure Control in Phase 3 Study Extension
In treatment-naïve patients, single-pill triple combination therapy sustained mean BP near 120/78 mmHg for 52 weeks with 96% study completion and good tolerability.
In treatment-naïve patients, single-pill triple combination therapy sustained mean BP near 120/78 mmHg for 52 weeks with 96% study completion and good tolerability.
London, UK, and Boston, MA – George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease, presented long-term efficacy and safety data from a 52-week open-label extension of its pivotal Phase 3 study in treatment-naïve patients with hypertension. In this 52-week follow-up period of 50 subjects, treatment with GMRx2 (US tradename WIDAPLIKTM), demonstrated sustained blood pressure (BP) control out to one year, with good tolerability and low treatment discontinuation.
The data were presented in a moderated poster session, “Change is in the Air! New Discoveries in Hypertension Treatment”, at the American Heart Association’s (AHA) Scientific Sessions 2025, taking place in New Orleans, USA.
WIDAPLIK is an innovative single pill combination of three medicines: telmisartan, amlodipine and indapamide, for the treatment of hypertension, developed in three doses, including two doses that are lower than those currently available in single pill combinations. By leveraging a multi-mechanism approach and lower doses, WIDAPLIK is formulated to deliver the blood pressure-lowering benefits of a triple combination therapy early in the treatment pathway, with the known safety profiles of existing antihypertensive medicines.
To evaluate the long-term efficacy and safety of WIDAPLIK-based treatment when used in usual clinical care, 50 participants from Sri Lanka and Nigeria sites of the placebo-controlled GMRx2_PCT study (NCT04518306), were enrolled into an open-label extension phase with GMRx2 treatment to one year. A total of 48 (96%) participants completed the study.
- Mean home and in-clinic blood pressures following 4-weeks of the core double blind study period entering into the open-label extension were 121/78 mmHg and 126/79 mmHg, respectively.
- Following 52-week open label dosing, mean home BP was maintained at 120/78 mmHg, as was in-clinic BP of 122/77 mmHg.
- Home BP control (<130/80 mmHg) was 56%, and clinic BP control (<140/90 mmHg) was 88% at the end of the open-label extension
- Tolerability was good, with no participants discontinuing treatment due to an adverse event.
Dr. Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University, New Orleans, Louisiana, and Past President of the World Hypertension League, who presented the data at Scientific Sessions 2025, said: “These data reinforce the value of single pill triple combination therapy to effectively manage hypertension in the long term. With globally recognized treatment guidelines acknowledging the preferred use of single pill combinations, and the addition of triple combination antihypertensives to the WHO’s Model List of Essential Medicines, there is growing global recognition of their potential to improve blood pressure control and help patients to stay on therapy.”
Mark Mallon, Chief Executive Officer of George Medicines, said: “We are proud that the long-term data from our Phase 3 program of GMRx2 have been shared at AHA Scientific Sessions, one of the most prestigious global forums for cardiovascular science. These results reinforce the potential of GMRx2 to transform hypertension treatment by offering a single-pill combination, in lower doses than are currently available, enabling more patients to achieve sustained blood pressure control.”
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