George Medicines has completed enrolment of patients in Phase III trial of three-in-one, low and ultra-low dose combination pill GMRx2 for the treatment of hypertension as first-line therapy.
The company’s lead pipeline candidate GMRx2 comprises telmisartan, amlodipine and indapamide, which are common hypertension therapeutics.
The active-controlled study is designed to compare GMRx2’s safety and efficacy against dual combinations of the same components.
It enrolled more than 1,300 patients across seven countries including Australia, the UK, and the US.
George Medicines chief operating officer Dr Karl Roberts said: “The progress of this Phase III programme is a huge testament to the dedication of the team and our partners working to bring GMRx2 to patients.
“There is an ambitious vision behind this combination candidate, to improve blood pressure control for patients globally, more quickly and without the tolerability and adherence challenges associated with currently available treatment options.
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“Ahead of the programme’s data readout anticipated later this year, we’re continuing our discussions with potential commercial partners for GMRx2 who share our belief in its potential and recognise the opportunity we have to transform how hypertension can be treated.”
In addition to the active sites, George Medicines is actively enrolling patients further in Europe, Africa and South Asia along with Imperial College London’s Imperial Clinical Trials Unit (ICTU) and RemediumOne in Sri Lanka.
A second trial in Phase III programme is also underway comparing patent-protected GMRx2 against placebo. It enrolled 250 patients from Sri Lanka, Nigeria, and the UK.
Both the trials are anticipated to announce topline safety and efficacy data in the fourth quarter of this year.