George Medicines has reported outcomes from two Phase III clinical trials of GMRx2, a hypertension treatment.
GMRx2 is a new triple combination pill that combines telmisartan, amlodipine, and indapamide in ultra-low and low-dose formulations.
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The first Phase III trial involved patients from the Czech Republic, Australia, New Zealand, Poland, Sri Lanka, the UK, and the US.
It tested GMRx2’s standard- and half-dose forms against dual combinations of its constituent drugs.
The trial’s primary aim was to assess its efficacy in reducing home-measured blood pressure from randomisation to week 12.
The results showed that the trial met all primary safety and efficacy endpoints.
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By GlobalDataGMRx2 demonstrated to outperform dual therapy in lowering both home- and clinic-measured blood pressure and in improving control rates.
The trial also demonstrated that the candidate’s half-dose achieved a 63% clinic blood pressure control rate, which increased to 74% with the standard dose.
Notably, the primary outcome showed GMRx2’s superiority over each of the three dual combinations for home systolic blood pressure reduction, with all endpoints meeting the statistical significance threshold.
Furthermore, the trial confirmed good tolerability, with no increase in treatment withdrawals due to adverse events.
The second Phase III trial, conducted across Nigeria, Australia, Sri Lanka, the UK, and the US, compared GMRx2’s half- and quarter-doses against a placebo.
Its focus was on the change in home-measured blood pressure from randomisation to week four.
GMRx2 demonstrated significant improvements in both home- and clinic-measured blood pressure and control rates at both dosage levels, without compromising tolerability in this trial.
These findings were presented at a Hot Line session of the European Society of Cardiology (ESC) Annual Meeting in the UK.
George Medicines chief medical officer professor Anthony Rodgers said: “The clinical and public health significance of these findings is considerable, given the continuing global disease burden of hypertension.
“Control rates are suboptimal in all countries, even where access and affordability are not major factors, principally due to continued use of low-efficacy regimens. With evidence increasingly showing the value of lower blood pressure targets, the potential of an effective, low-dose, triple combination with a good safety profile for the early treatment of hypertension should not be underestimated.”
