March 22, 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 latest patient has completed participation in a clinical trial that includes Company integrates precision care product solution. for patients with hypertension.
Closed Loop Medicine develops drug and digital therapeutic combination products centered around dose optimization, to improve outcomes for patients, support clinicians, and enable a movement toward a value-based medicine proposition for healthcare systems by providing precision care on a population health scale.
The clinical trial, called PERSONAL COVID BP, aims to investigate whether a combination product that connects a drug to a smartphone app allows patients to personalize and optimize their therapy regimen to treat hypertension. Importantly, the technology in the study allowed patients protected from COVID-19 to report COVID-19 infection-related symptoms and also to monitor their blood pressure remotely, every day, from home. The company quickly developed its approach to continuing studies through the COVID-19 barrier, redesigning the studies to run remotely and through technology development, also using the uMED decentralized clinical testing platform.
The intervention 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 are used to guide the development of the company’s highly innovative product, which provides precision control of blood pressure on the population health scale. The product will save lives by addressing the number 1 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, DC. It is also published online in the Journal of the American College of Cardiology (JACC).
The trial is partly funded by Innovate UK and was led by the William Harvey Clinical Research Center at Queen Mary University of London, part of the National Institute for Health Research Biomedical Research Center at the Barts NHS Trust in London UK.
Following Closed Loop Medicine Success to Secure a Place on the Association of British HealthTech Industries (ABHI) US Accelerator Program Early in January 2022, the company explored additional clinical options in the US healthcare system to support the development of its new 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 most recent patient dosing and follow-up treatment completed in our interventional clinical study. Our goal is to improve patient outcomes while supporting healthcare systems to better manage patients with long-term conditions through linked remote monitoring and precision drug intervention. The process design allows for more patient participation in the comfort and safety of their own home. I am pleased that we have successfully completed recruitment, despite the limitations of the COVID-19 pandemic. We are pleased to present the results of this important process to our partners at Queen Mary University of London.
Dr David Collier, Lead Process Investigator at Queen Mary University of London, commented:
This is an important study in that it allows patients and physicians to collect real-world data to inform better treatment decisions and monitor patient outcomes. Some of the drugs we use are great for preventing heart attacks and strokes, but often cause unwanted side effects, something that has put this process off. We show through this study that one size does not fit all, but that we can use technology in this combined way to personalize the treatment for the individual. This personalization seems to have the potential to change participants’ relationship to treatment as they see the effect of different treatment levels on their blood pressure while carefully examining for adverse effects. This “personalized dose-response curve” has implications for participants and clinicians and we are excited to confirm their impact on the whole group.
The participants, some over 80 years old, were very attached to their remote application and yet, for daily blood pressure monitoring for three months, were excited that they would have to clear it at the end of the trial “It was like an angel at my shoulder” sot ee Participant “.
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