- Study aims to validate development of a novel combination product that links a drug to a smart phone app, enabling patients to personalise and optimise their therapy regimen to treat hypertension and prevent heart attacks and stroke
- The trial, called PERSONAL COVID BP, was part-funded by Innovate UK and run by the William Harvey Clinical Research Centre at Queen Mary University of London
- Last of 200 patients with hypertension has completed the 14 weeks’ treatment phase as well as the required 2-4 weeks’ follow up period
- Full results from the study are expected in Q2 2022, and will be presented at the American College of Cardiology (ACC) for presentation at the ACC Annual Scientific Session in April 2022 in Washington D.C.
Cambridge and London, UK, 22 March 2022: Closed Loop Medicine Ltd, a leader in the development of single prescription drug plus digital therapy (DTx) combination products to enable precision dosing and care, announced today that the last patient has completed participation in a clinical trial investigating the Company’s integrated precision care product solution for patients with hypertension.
Closed Loop Medicine is developing drug and digital therapeutic combination products centred around dose optimization, to improve outcomes for patients, support clinicians, and enable a move towards a value-based medicine proposition for health systems by delivering precision care at a population health scale.
The clinical trial, called PERSONAL COVID BP, aimed to investigate whether a combination product that links a drug to a smart phone app can enable patients to personalize and optimise their therapy regimen to treat hypertension. Importantly, the technology in the study allowed patients shielding from COVID-19 to report COVID-19 infection related symptoms as well as control their blood pressure remotely, on a daily basis, from home. The Company rapidly evolved its approach to continue studies through the COVID-19 lockdown, by re-designing studies to run remotely and through technology development, including using the uMED decentralised clinical trial platform.
The interventional arm of the study exceeded its recruitment target of 200 patients, with patients receiving drug therapy while using an app to monitor blood pressure and any potential side effects. The data from this study is being used to drive the development of the Company’s highly innovative product that will deliver precision control of blood pressure at population health scale. The product will save lives by addressing the number one killer in the western world (1), high blood pressure – which, even in the pre-vaccination year of COVID-19 in 2020, killed more people than cancer or COVID-19 (2).
Preliminary data from this study will be presented at the ACC 71st Annual Scientific Session, April 2-4, live in Washington, D.C. It will also be published online in the Journal of the American College of Cardiology (JACC).
The trial is part-funded by Innovate UK and was run by the William Harvey Clinical Research Centre at Queen Mary University of London, part of the National Institute for Health Research Biomedical Research Centre at Barts NHS Trust in London UK.
Following Closed Loop Medical’s success in securing a place on the Association of British HealthTech Industries (ABHI) US Accelerator programme earlier in January 2022, the Company is exploring additional clinical opportunities within the US healthcare system to support the development of its novel precision care product for patients with hypertension.
Dr Hakim Yadi OBE, CEO & Co-Founder of Closed Loop Medicine commented: “This represents a key milestone for the company, the last patient dosed and follow-up treatment completed in our interventional clinical study. Our aim is to improve patient outcomes while supporting health systems to better manage patients with long-term conditions through linked remote monitoring and precision drug intervention. The trial design allowed greater patient participation from the comfort and safety of their own home. I am delighted that we were able to successfully complete recruitment, despite the constraints of the COVID-19 pandemic. We look forward to presenting the results of this important trial alongside our partners at Queen Mary University of London.”
Dr David Collier, the lead trial investigator from Queen Mary University of London, commented: “This is an important study in that it allows patients and physicians to collect real-world data to help better inform treatment decisions and monitor patient outcomes. Some of the drugs we use are great at preventing heart attacks and strokes, but frequently cause unwanted side-effects, something this trial sets out to address. We are demonstrating through this study that one size does not fit all, but that by using technology in this combined way, we can personalise treatment for the individual. This personalisation seems to have potential to change participants relationship to treatment, as they see the effect of different levels of treatment on their blood pressure whilst carefully checking for unwanted effects. This “personalised dose-response curve” has a meaning for participants and clinicians and we’re excited to confirm its impact on the whole group.”
“Participants, some over 80 years of age became very attached to their remote app and despite it prompting for daily blood pressure recording for three months were upset that they had to delete it at the end of the trial “It was like an angel at my shoulder” said one participant”.