Remote cellular-enabled blood pressure monitoring provides novel and secure way of collecting real world data (RWD) in decentralised global phase III pivotal study.
Unique remote device monitoring (RDM) capabilities of Medisanté’s medical IoT platform (M+ Hub) enhance George Medicines’ clinical trial management system.
Seamless decentralised data collection of blood pressure measurements over a secure private cellular network reduces patient burden of site visits.
Gilles Lunzenfichter, CEO of Medisanté, to participate in panel event at American Telemedicine Association’s (ATA) Telehealth Awareness Week, 21 September.
London (UK) and Lucerne (Switzerland), 15 September 2022 – George Medicines, a late-stage drug development company focused on providing innovative and accessible medicines for the world’s leading causes of death, and Medisanté, a Swiss-based global innovator in medical IoT (Internet of Things) are collaborating on a novel way of collecting real world data (RWD) in decentralised clinical trials (DCT).
George Medicines’ pivotal Phase III trial, investigating the Company’s proprietary single-pill triple combination candidate, GMRx2, as a first-line treatment for hypertension, is enrolling 1,500 patients across sites in seven countries, including the US, UK and Australia. Through Medisanté’s technology platform and cellular-enabled devices, trial patients are able to provide blood pressure measurements remotely, rather than maintaining a diary at home, reducing the need for multiple study centre site visits.
IoT devices are increasingly being used in clinical research as trial sponsors explore new ways to automate the remote collection of physiological readings in a way that requires no device configuration or diary keeping by the patients. In the GMRx2 trial, Medisanté enables, in near real time, the automated transmission of blood pressure readings – taken at home by the patients – into George Medicines’ clinical trial management system.
Stefan König, CEO of George Medicines, said: “Telemedicine is the leading decentralisation approach in clinical trials today and one that can help us to improve how we study the effects of our medicines on patients. Our fundamental goal in this trial is to gather high quality, accurate data that will enable us to determine the impact our single-pill, triple combination candidate has on reducing patients’ blood pressure. Using Medisanté’s technology to gather that data, and at the same time relieve the burden on patients from multiple visits to the clinic for a simple blood pressure measurement they can do at home, that is a significant win for this trial and for the patients who volunteer to help us.”
Gilles Lunzenfichter, CEO of Medisanté, said: “We are delighted that Medisanté can be the trusted and global IoT partner for George Medicines’ clinical trial. Our cellular-enabled devices, which are designed for virtual care, deliver a seamless and secure device experience for patients, while allowing investigators to onboard patients regardless of their social determinants of health. Providing the technology to support 1,500 trial patients and their investigators across seven countries is a further validation of our medical IoT strategy. We are committed to deliver seamless device interoperability to George Medicines and to minimise the devices’ total cost of ownership as the company scales its trial.”
George Medicines’ mission is to extend and improve the lives of the millions of people suffering from non-communicable diseases (NCDs), the world’s leading causes of death and disability, such as hypertension, diabetes and other common cardiometabolic disorders. Its innovative, single-pill, multi-mechanism combinations of best-in-class, existing treatments in ultra-low doses, have the potential to reduce the impact of NCDs on patients, families, health systems and economies.
GMRx2 is George Medicines’ most advanced candidate in late-stage development. A single-pill, triple combination for the first-line treatment of hypertension, GMRx2 contains telmisartan, amlodipine and indapamide – three best-in-class, existing treatments. Patients are currently being recruited for the pivotal Phase III trial across more than 30 participating sites with results expected to support regulatory filings for approval. The trial is designed to evaluate the safety and efficacy of GMRx2 compared to dual combinations of the same components.
Gilles Lunzenfichter, CEO of Medisanté, will participate in the American Telemedicine Association’s (ATA) Telehealth Awareness Week panel, Leveraging IoT and Telehealth in DCTs for recruitment and retention of diverse participants, on Wednesday 21 September 2022, 2pm to 3pm Eastern Time. Learn more, or register for the event, here.
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Stefan König, Chief Executive Officer
Consilium Strategic Communications
David Daley, Lindsey Neville, Isabelle Abdou
Tel: +44 (0) 203 709 5700
Gilles Lunzenfichter CEO and Co-Founder
About George Medicines
George Medicines is a late-stage drug development company focused on improving the management of non-communicable diseases (NCDs) with patented, innovative, multi-mechanism combinations of existing medicines given at ultra-low doses.
Combining best-in-class molecules from existing medicines in novel low-dose formulations, George Medicines is developing innovative and proprietary treatments that are more efficacious, safer and accessible than currently available treatment options. These single-pill, multi-mechanism combinations offer the potential to bring significant improvements in clinical outcomes and therapy adherence in patients with NCDs, including hypertension, diabetes and other common cardiometabolic disorders, each of which remain the leading causes of premature death and disability worldwide.
The Company is building a strong and diversified pipeline of patented, single-pill, multi-mechanism combination therapies. Its lead candidate, GMRx2, is in Phase III development for the initial treatment of hypertension and under investigation for the prevention of recurrent intracerebral haemorrhage (the most severe type of stroke).
George Medicines is a spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia’s leading life sciences venture capital firm, supported by the Australian Government. For more information, please visit www.george-medicines.com.
About Medisanté Group AG
Medisanté is headquartered in Switzerland and is part of the PariSanté Campus digital health ecosystem. It enables the hospital at home with global medical IoT. By connecting/managing in one cloud a broad range of devices/gateways via a private cellular network, it redefines device interoperability and monitoring for technical teams and delivers medical IoT data as a Service to care teams in the virtual care platform of their choice. Medisanté keeps the device experience seamless and secure at scale for care teams and patients by leveraging global cloud and IoT technologies for non-identifiable device data while leaving the data sovereignty over sensitive patient data to compliant virtual care platforms. Medisanté Hub (M+ Hub) is the only medical IoT platform that delivers remote device monitoring (RDM) across vendor, platform, and country silos and makes no compromise on privacy or inclusion. It allows care teams to scale virtual care while minimizing the devices’ total cost of ownership (TCO). For more information, please visit https://www.medisante-group.com/.