Closed Loop Medicine wraps DTx trial for hypertension treatment

Closed Loop Medicine, a company that develops solutions combining single prescription drugs with digital therapeutics (DTx), has announced the final patient has completed their participation in a study evaluating its integrated precision care treatment for patients with hypertension.

The clinical trial, named Personal COVID BP, set out to investigate if the combination product linking a dug to a smartphone application could be helpful in empowering patients to personalize and optimize their hypertension treatment regimen. To learn more about the solution and the study, Outsourcing-Pharma connected with Hakim Yadi, CEO of Closed Loop Medicine.

OSP: Could you please tell us a bit about Closed Loop Medicine—who you are, what you do, key capabilities, and what sets you apart from other companies doing similar work?​

HY: Closed Loop Medicine is a new breed of healthcare company, combining the worlds of traditional drug-based therapeutics with the emerging world of software as a medical device and digital therapy into single prescription products. We believe that the best way to deliver meaningful outcomes to patients is through integrated care that brings together the often siloed modalities of traditional therapeutics and companion care services, such as coaching wellness and behavioral medicine.

At the heart of our approach to personalized integrated care is to use the insights we gather through technology to optimize and personalize the dose of the medication. One size does not fit all when it comes to medicine.

OSP: Please tell us how Closed Loop came to work with the William Harvey Clinical Research Centre—have you worked with the team at that center in the past?​

HY: Closed Loop Medicine has had a long relationship with the William Harvey Research Institute at Queen Mary University London, which is internationally recognized as a center of excellence for cardiovascular research Our relationship began through one of our co-founders who was working closely with clinicians to identify those drugs and diseases where our combination approach would enable better-tailored care for patients. From these early interactions, we were fortunate enough to partner with the William Harvey Clinical Research Center and secure a substantial Innovate UK grant to support our work in the personalization of hypertension care management through precision dosing.

OSP: Please tell us a bit about recent developments in digital therapeutics, and how past advancements have helped lead up to this innovative clinical trial.​

HY: The world of digital health has seen a huge uplift in utilization and importance, in light of our need to decentralize care in response to the COVID-19 pandemic. One area that has seen a significant focus has been on the decentralization of clinical trials using electronic medical records and multi-center study sites to enable more rapid and meaningful recruitment to clinical studies.

One element of this innovative study was to leverage the capabilities of decentralized clinical trials through a partnership with uMed. uMed became a valuable tool in supporting patient recruitment into this innovative clinical study led by Queen Mary University of London.

OSP: How did the collaborators come up with the concept for the Personal COVID BP trial?​

HY: Our aim is to use an innovative combination approach linking known drugs and our unique software as a medical device to be able to inform a precision dosing approach that optimizes the patient’s therapeutic window, finding that fine balance between efficacy and side effects at an individualized level.

Through our partnership at Queen Mary University London, we found a shared belief in the need for better personalization both to improve outcomes and improve adherence to a clinical regimen. It was a highly creative and collaborative endeavor in designing the study and in delivering, especially during such turbulent times as the whole study was completed during the COVID-19 pandemic.

OSP: Could you please share some insight as to how the smartphone app works and how patients interact with it?​

HY: During the study, the clinical trial participants were provided access to an app that allowed them to capture data on their drug regimen, any changes made to that regimen during the course of the study, their daily blood pressure, and importantly any side effects they might have experienced whilst taking the drug.

The development route that we are taking for a commercialized product will be a single prescription combination drug plus software as a medical device integrated product, enabling the patient to easily access the software as a medical device app as part of receiving their medication prescription.

OSP: Please tell us about what the collaborators might have expected or hoped to determine in the course of the Personal COVID BP study.​

HY: The aim of the study was to determine if a novel combination approach would support patients in better optimizing their care and helping them achieve blood pressure management control without the burden of unwanted side effects. As the study was delivered during COVID, we wanted to support the collection of real-world data and real-time insights on the association between high blood pressure and COVID-19, given the early reports of comorbidity between these two diseases.

OSP: Were there any surprising or otherwise notable findings you can tell us about?​

HY: Some of the most interesting preliminary results have recently been published at the American College of Cardiology conference in Washington held in April where we co-presented with Queen Mary University London our findings, demonstrating that one size does not fit all and a degree of personalization can lead to better outcomes for patients in terms of finding the sweet spot between efficacy and side-effects ensuring maintenance of blood pressure control.

One of the most interesting qualitative findings from the study through interviews with patients and feedback on the clinical trial has been that the varied process of working closely with their own data and clinicians to understand the benefits of altering dose, has enabled patients to feel far more empowered and confident about the value of the drug they are taking. Unlike taking a suit off the peg, this has been a bespoke ‘Savile Row’ experience for them.

OSP: Can you share any lessons this study might offer to researchers, pharma companies, care providers, or others in general?​

HY: Our belief is that the future of care lies in the convergence of data - between patient-reported outcomes, drug therapy, and medical devices, closing the loop to provide the digital delivery of a tailored, dose-optimized care regimen. The challenge with traditional models of care is that both the products, the services, and the data that lies across them are deeply siloed.

If we are to really move towards value and outcomes-based models of care delivery, we will have to be able to capture longitudinal integrated care insights. At Closed Loop Medicine we’ve developed the processes, systems, and expertise to enable healthcare innovators to do just this.