Today, the UK biotech company Closed Loop Medicine announced the publication of a peer-reviewed study in the Journal of the American Heart Association.
Founded in 2017, Closed Loop is developing combination prescription drug plus software therapy products that deliver personalised dose optimisation. The company has raised £17 million in funding.
Hypertension is the leading preventable cause of morbidity and premature death worldwide. Despite being a first-line recommended anti-hypertensive drug, ~20 percent of patients discontinue amlodipine after a single prescription largely due to unwanted effects, such as peripheral oedema, which is strongly dependent on dose.
The study describes the results of the PERSONAL-CovidBP clinical trial, demonstrating the capabilities of the company’s integrated precision care solution, CLM-HT01, to successfully control blood pressure (BP) whilst minimising side effects and supporting medication adherence in participants with primary hypertension.
Specifically, the research looked at the use of smartphone-enabled remote precision dosing of amlodipine during the COVID-19 pandemic.
It reinforces the ability to use a digital companion alongside traditional therapeutics to optimise clinical outcomes. This was achieved by adjusting and personalising drug dosing using information recorded by participants into a dedicated smartphone app and transmitted securely to a clinician.
Clinically significant reductions in BP were rapidly observed, with the majority of participants achieving BP control and minimising side effects, including those previously intolerant of conventional amlodipine doses. High adherence rates were reported (both app usage and medication), and patient retention was exceptionally high with no discontinuations due to drug intolerance.
The findings will be applied to drive further development of CLM-HT01 and the company’s extended pipeline of combination products in other therapeutic areas, aiming to deliver precision dosing at population scale.
Dr Hakim Yadi OBE, CEO and co-founder of Closed Loop Medicine, commented:
“These findings are invaluable in demonstrating the power of personalising the dose of existing therapeutics in areas as widely impactful as hypertension.
We now want to take these learnings and apply them more broadly where we feel they will have a huge impact, for example, to minimise the adverse effects limiting GLP-1 programmes – an area currently seeing huge attention.
To improve patient outcomes, we need to shift to a world where we treat the individual, not only the disease. Our inventions will work in combination with medicine to deliver personalised, optimised dosing; improving human health.”
Dr David Collier, the lead trial investigator from Queen Mary University of London, said:
“We are incredibly pleased to have the final results from the PERSONAL-CovidBP trial published in the JAHA, a leading open access scientific journal.
We wanted to use personalised dosing of amlodipine, and had worked with our patients to develop a digital platform to allow this.
Working remotely due to COVID we still managed to recruit, triage (selected participants according to home blood pressure),and then treat patients with this novel approach.
Often starting with very small doses, empowering participants to share both wanted and unwanted effects of medication helped us to work together to reduce blood pressure while minimising any side-effects. Some participants who had never tolerated full doses of any blood pressure medication got control for the first time.”
PERSONAL-CovidBP was part-funded by Innovate UK and 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.
Lead image: Closed Loop Medicine. Photo: uncredited.