George Medicines showcases new low-dose triple pill for hypertension at ESC Congress 2024

George Medicines has unveiled promising outcomes from two pivotal Phase III trials of its novel, low-dose, triple combination pill for hypertension, GMRx2, during the European Society of Cardiology (ESC) Congress 2024 in London. The trials emphasize the potential of this innovative treatment to reshape hypertension management by improving blood pressure (BP) control and patient adherence.

Hypertension remains a global health challenge. Traditional treatments often fail to achieve optimal BP control, largely due to the use of monotherapy or suboptimal drug combinations. Current triple combination therapies are typically prescribed only when other treatments fail. GMRx2, however, is designed to be more effective from the outset, combining telmisartan, amlodipine, and indapamide in ultra-low, low, and standard-dose formulations.

The first Phase III trial spanned Australia, Czech Republic, New Zealand, Poland, Sri Lanka, UK, and the US. It compared GMRx2, in its standard- and half-dose forms, to dual combinations of its component drugs. The primary efficacy outcome was the reduction in home-measured BP from randomization to week 12. The findings highlighted that GMRx2 outperformed dual therapies, significantly lowering both home- and clinic-measured BP and improving BP control rates. The trial achieved its primary safety and efficacy endpoints, showing that GMRx2 is more effective than dual combinations without increasing adverse event withdrawals. Specifically, the GMRx2 half-dose achieved 63% clinic BP control <140/90mmHg, rising to 74% with the standard-dose, surpassing all dual combinations (53-61%).

The second Phase III trial, conducted in Australia, Nigeria, Sri Lanka, UK, and the US, compared half- and quarter-doses of GMRx2 to a placebo. The trial's primary outcome was the change in home-measured BP from randomization to week 4. Results demonstrated that GMRx2 significantly improved BP control in both dosages without an increase in adverse events.

At the ESC Congress, Professor Anthony Rodgers, Chief Medical Officer of George Medicines, underscored the significance of these findings given the ongoing global hypertension burden. He noted that despite guidelines recommending lower BP targets, many countries still struggle with suboptimal control rates due to ineffective treatment regimens. He emphasized the potential of an effective, low-dose, triple combination with a good safety profile for early hypertension treatment.

Dr. Paul Whelton, Chair of the trials’ steering committee and President of the World Hypertension League, highlighted the global impact of these clinical trial results, affirming GMRx2 as a breakthrough antihypertensive therapy.

Additionally, the ESC Congress presented findings from the first trial in Africa evaluating a low-dose triple combination pill as initial or early therapy for hypertension. Conducted in Nigeria, the VERONICA trial involved black African adults with uncontrolled hypertension. The trial compared a GMRx2-based treatment protocol to standard care over six months. Results showed significant efficacy and safety improvements, with over 80% BP control achieved and maintained throughout the follow-up period. No patients withdrew due to adverse events, and the trial highlighted GMRx2’s good tolerability.

Mark Mallon, CEO of George Medicines, emphasized that these comprehensive data reinforce GMRx2’s potential to transform hypertension management globally. He noted that, subject to regulatory review, GMRx2 could be the first new hypertension treatment approved in over a decade, making a significant impact, especially in low- and middle-income countries.

George Medicines recently submitted a New Drug Application (NDA) for GMRx2 to the US Food and Drug Administration (FDA). The company’s development program builds on earlier research, including the 700-patient TRIUMPH trial in Sri Lanka, which demonstrated the efficacy of a low-dose triple combination pill in achieving target BP goals.

Hypertension affects over one billion adults worldwide. In the US, nearly half of adults have hypertension, with only about a quarter achieving control. The UK faces similar challenges, with many undiagnosed or inadequately treated cases. Effective management is hindered by inadequate therapy, complex medication regimens, and poor adherence. George Medicines aims to address these issues with its innovative treatments, leveraging existing drugs in novel formulations for optimal efficacy and safety.

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