Pharma Focus Europe

George Medicines Concludes Recruitment for Initial Phase III Trial Assessing Innovative Single-pill Triple Combination Candidate GMRx2 in Hypertension

Thursday, July 13, 2023

George Medicines, a company specializing in late-stage drug development and focused on revolutionizing the management of cardiometabolic disease, has announced the successful completion of patient enrollment in its Phase III active-controlled trial. The trial aims to assess the safety and efficacy of GMRx2, the company's primary candidate, as a treatment for hypertension, including its potential as a first-line therapy.

The trial has enrolled over 1,300 patients across seven countries, including the United States, United Kingdom, and Australia. It compares GMRx2, a proprietary single-pill combination of telmisartan, amlodipine, and indapamide (three highly regarded existing treatments), with dual combinations of the same components.

George Medicines is dedicated to extending and enhancing the lives of millions of individuals suffering from non-communicable cardiometabolic diseases, such as hypertension and diabetes, which are the leading causes of death and disability worldwide. The company's patent-protected single-pill, multi-mechanism combinations of low and ultra-low doses of existing treatments have the potential to mitigate the impact of these diseases on patients, families, healthcare systems, and economies globally.

Globally, over one billion people have hypertension, but less than 20% have their condition under control. Existing antihypertensive medications are only moderately effective in reducing blood pressure, even at high doses, and many patients require multiple medications to achieve adequate control.

GMRx2 is formulated in novel, patent-protected low and ultra-low doses, providing a convenient solution for targeted blood pressure control across different patient groups. Its multiple mechanisms, at low doses, work synergistically and additively, potentially offering effectiveness across a wide range of patients and suitability for earlier stages of treatment. This approach eliminates the need for traditional stepwise testing and titration of multiple medications. Furthermore, the once-daily dosing regimen with a single pill improves medication adherence.

Dr. Karl Roberts, Chief Operating Officer of George Medicines, expressed his appreciation for the progress made in the Phase III program. He highlighted the company's ambitious vision to enhance global blood pressure control quickly and address the tolerability and adherence challenges associated with existing treatment options. As the program's data readout is expected later this year, George Medicines continues discussions with potential commercial partners who share their belief in the candidate's potential and recognize the opportunity to revolutionize the treatment of hypertension.

Additionally, George Medicines has recently expanded its second trial of GMRx2, a placebo-controlled study involving 250 patients, to include the United Kingdom, Nigeria, and Sri Lanka. The trial, already active in the United States and Australia, is now actively recruiting patients across Europe, Africa, and South Asia through collaborations with the Imperial Clinical Trials Unit (ICTU) at Imperial College London, RemediumOne in Sri Lanka, and global clinical research organization George Clinical.

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