Closed Loop Medicine Demonstrates Application of Novel Drug Plus Software Product for Personalized Treatment of Hypertension

By: Closed Loop Medicine via Business Wire

February 08, 2024 at 04:59 AM EST

Study published in JAHA validates use of proprietary technology to identify personalized dose regimen, leading to improved blood pressure control and exceptionally high adherence in hypertension patients
Findings will guide the Company’s strategy to expand portfolio of differentiated dose-optimized therapies, including within GLP-1 market

Closed Loop Medicine Ltd., a leading TechBio company developing combination prescription drug plus software therapy products that deliver personalized dose optimization, today announced the publication of a peer-reviewed study in the Journal of the American Heart Association (JAHA) (1). The study describes 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 minimizing side effects and supporting medication adherence in participants with primary hypertension. 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.

Hypertension is the leading preventable cause of morbidity and premature death worldwide. Despite being a first-line recommended anti-hypertensive drug, ~20% of patients discontinue amlodipine after a single prescription largely due to unwanted effects, such as peripheral oedema, which is strongly dependent on dose. CLM-HT01 is a single label combination product in development, linking Closed Loop Medicine’s proprietary software as a medical device (SaMD) with amlodipine, designed to support more effective, precise, and affordable disease management solutions to improve outcomes for patients and streamline clinician input.

The study “Personalized antihypertensive treatment optimization with smartphone-enabled remote precision dosing of amlodipine during the COVID-19 pandemic” reinforces the ability to use a digital companion alongside traditional therapeutics to optimize clinical outcomes. This was achieved by adjusting and personalizing 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 minimizing 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 build on preliminary results published in the Journal of the American College of Cardiology (2) and the Journal of Human Hypertension (3).

Dr. Hakim Yadi OBE, CEO & Co-Founder of Closed Loop Medicine, commented: “These findings are invaluable in demonstrating the power of personalizing 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 the most impact, for example to minimize the adverse effects limiting GLP-1 programmes – an area currently seeing huge attention.” He added: “To improve patient outcomes, we need to shift to a world where we treat the individual, not just the disease. Our inventions will work in combination with medicine to deliver personalized, optimized 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.” He added: “We wanted to use personalized 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 minimizing any side-effects. Some participants who had never tolerated full doses of any blood pressure medication got control for the first time.”

Dr. Mike Taylor, Senior Vice President Clinical Development of Closed Loop Medicine, added: “Data generated in this study in hypertension demonstrate significant benefits offered by precision dose titration enabled by a dedicated smart phone app. This novel technology enables clinicians to efficiently personalize and optimize therapy routines for patients, leading to improved health outcomes by finding a better balance between efficacy and unwanted effects. Daily self-monitoring and side effect reporting empowers patients through a more comprehensive understanding of how medication impacts overall wellbeing, whilst providing more peace of mind knowing that a clinician is able to assess changes in real-time and optimize the tolerability and efficacy of said drug treatment.”

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.