Medicines posts positive results for triple-combo blood pressure drug on heels of FDA submission
With a positive readout for its three-in-one hypertension drug, London-based George Medicines is one step closer to the market on its quest to tackle widespread conditions like high blood pressure, diabetes and other common cardiometabolic disorders.
Early Saturday, George Medicines revealed that its hypertension candidate GMRx2 met all primary safety and efficacy outcomes in a phase 3 study. The trial pitted the triplet drug candidate against dual combinations of GMRx2's long-approved components—telmisartan, amlodipine and indapamide.
George Medicines’ hypertension prospect specifically comes in bespoke triple-quarter (ultrlow dose), triple half-dose (low-dose) and triple standard-dose formats.
The positive data drop comes after George Medicines submitted its combination pill for a potential FDA approval earlier this month. The company presented the latest results on GMRx2 at the European Society of Cardiology (ESC) annual meeting in London on Saturday.
In George Medicines’ phase 3 study—which looked at patients with high blood pressure in Australia, the Czech Republic, New Zealand, Poland, Sri Lanka, the U.K. and the U.S.—GMRx2 at standard- and half-dose forms proved more effective than dual therapy with the candidate’s constituent drugs, the company said in a release.
The primary outcome of the study looked at the superiority of GMRx2 versus each of the three dual combinations for systolic blood pressure reduction.
Digging deeper into the numbers, a half dose of George Medicines’ pill achieved a 63% rate of clinical blood pressure control, while the standard dose's result came in at 74%. By comparison, all three dual combinations of the pill’s drug components at standard doses chalked up results ranging from 53% to 61% on hypertension control metrics, George Medicines said.
Meanwhile, in a second phase 3 trial run in Australia, Nigeria, Sri Lanka, the U.K. and the U.S., half- and quarter-doses of GMRx2 “significantly improved” home- and clinic-measured blood pressure control compared with placebo, the company added.
“The clinical and public health significance of these findings is considerable, given the continuing global disease burden of hypertension,” Anthony Rodgers, Ph.D., George Medicines’ chief medical officer, said in a statement. “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.”
In its release, George Medicines said that most people treated for hypertension fail to achieve sustained blood pressure control, in large part due to “continued use of low efficacy regimens such as monotherapy.”
While there are triple combination medicines for hypertension available today, they’re restricted to patients who are still not achieving adequate blood pressure control following therapy with the three separate drugs or two of the components, the company explained.
Back at the start of August, George Medicines said it filed a new drug application for GMRx2 with the FDA.
George Medicines, based in the U.K., is endeavoring to develop “innovative, single-pill, multi-mechanism combinations of best-in-class approved treatments” for common and debilitating diseases like hypertension, diabetes and other cardiometabolic disorders, according to its website. The late-stage company is a spinout from the George Institute for Global Health—a research organization focused on tackling global health inequity.
