Novel drug and software combo tackles hypertension with personalised treatment

  • 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.


References

  • Collier D et al. 2024. https://www.ahajournals.org/doi/full/10.1161/JAHA.123.030749
  • Taylor M et al. 2022. https://doi.org/10.1016/S0735-1097(22)02988-6
  •  Collier D et al. 2022. https://doi.org/10.1038/s41371-022-00734-5

More news and updates 

RSSL announces new Biotech Innovation Hub

RSSL, a leading pharmaceutical contract research organisation, has today announced plans to launch its new Innovation Hub, a dedicated platform to help small- and medium-sized biotech organisations de-risk and accelerate the development of cutting-edge products.

Aleta Biotherapeutics and Cancer Research UK announce first patient dosed in ALETA-001 Phase 1/2 clinical trial

The Phase 1/2 clinical trial will evaluate safety, dose, PK/PD, and early efficacy signals of Aleta’s first-in-class biologic CAR T-cell engager, ALETA-001. ALETA-001 entering the clinic is a critical milestone toward treatment availability to improve CAR T-cell patient response when a complete response is not achieved or maintained.

UKHSA announced as first PACE collaboration to help tackle deadly antimicrobial resistance

Strategic partnership to support AMR innovators

PrecisionLife and Metrodora Institute partner to accelerate diagnosis of Long COVID

Rapid development and clinical validation of diagnostics that enable innovative clinical care pathways in complex, chronic diseases; targeted precision medicine clinical trials leveraging a complementary diagnostic approach are expected to readout results as early as this year

Optibrium enables collaborative design in its StarDrop platform

The new Idea Tracker capability further improves the efficiency of drug discovery by supporting project management, idea sharing and molecule design tracking.

BugBiome secures investment for pioneering research in sustainable pest protection

BugBiome raises £310,000 in pre-seed investment from Cambridge Angels and Discovery Park Ventures. Investment enables a £330,000 Engineering Biology Grant from Innovate UK for cutting-edge agri-tech research leveraging the microbiome and engineering biology approaches.

Study reveals POLB 001 could be a $10 billion game changer for cancer patients

Independent Research Confirms >$10bn Market Opportunity for POLB 001 as a Preventative Therapy for Cancer Immunotherapy-Induced Cytokine Release Syndrome (CRS). Former Amryt Pharma team's arrival supports increasing focus upon Rare and Orphan Diseases

Demand for Golden Triangle lab space surges with highest annual volume since 2015

Demand for life sciences space in the ‘Golden Triangle’ surged in 2023, with the 925,000 sq ft of space representing the highest annual volume since 2015, according to the latest figures from Cushman & Wakefield.

New £100 million engineering biology fund

Six new Engineering Biology Mission Hubs and 22 Mission Awards, to transform solutions in areas like vaccine development, textile manufacturing and food production; New investments to unlock potential of engineering biology as part of the wider National Engineering Biology Programme

Pioneer Group’s regeneration plans for Cambridge’s Grafton Centre approved

Pioneer Group, a leading developer and operator of life science and high-tech campuses, has secured planning permission from Cambridge City Council, subject to S106, for the redevelopment of the Grafton Centre in the city.



 

More within