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US showcase for novel app+drug hypertension treatment

24/03/2022

Data from a clinical trial on a new hypertension drug produced by Cambridge company Closed Loop Medicine will be presented to a scientific summit in Washington DC in early April.

The Babraham Research Campus company says the last high blood pressure patient has completed testing in the PERSONAL COVID BP trial.

The research aimed to investigate whether a combination product that links a drug to a smart phone app could enable patients to personalise and optimise their therapy regimen to treat the condition.

Importantly, the technology in the study allowed patients shielding from COVID-19 to report infection-related symptoms as well as control their blood pressure remotely, on a daily basis, from home. 

Closed Loop Medicine rapidly evolved its approach to continue monitoring 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 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 – high blood pressure – which, even in the pre-vaccination year of COVID-19 in 2020, killed more people than cancer or COVID-19.

Preliminary data from the study will be presented at the ACC 71st Annual Scientific Session, April 2-4, live in Washington and will also be published online in the Journal of the American College of Cardiology.

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 Medicine’s success in securing a place on the Association of British HealthTech Industries 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, CEO & co-founder of Closed Loop Medicine said: “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, added: “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. One participant commented: ‘It was like an angel at my shoulder.’”

Published on: 22.03.22

Article sourced from www.businessweekly.co.uk