Closed Loop Medicine and Pharmanovia have announced the initiation of their OptiZest study, ID: NCT06372470, and first patient recruitment.

OptiZest will investigate whether patients with hypertension can improve blood pressure control at home while receiving a personalised dose of Zestril (lisinopril). The study demonstrates an important stage in Closed Loop Medicine and Pharmanovia’s co-development partnership to progress the development and launch of a drug plus software combination version of a first-line anti-hypertensive in the UK, before phased global roll-out and additional therapeutic areas are added.

Hypertension is a leading preventable cause of morbidity and premature death worldwide, impacting over 1 in 4 men and 1 in 5 women, and costing the NHS alone over £2.1 billion/year. Medication and lifestyle interventions have been shown to significantly reduce associated health risks and improve quality of life, however, poor drug tolerability and treatment-related side effects significantly impact adherence and overall disease management.

By combining Closed Loop Medicine’s proprietary Software-as-a-Medical Device (SaMD) dose optimisation technology and Pharmanovia’s established medicine brands, the companies aim to support patients and healthcare professionals through the development of an innovative intervention. The partnership is initially focused on addressing the clinical need in hypertension, which builds on recent trial data demonstrating the ability of Closed Loop Medicine’s SaMD platform to successfully control blood pressure, minimise side effects, and support medication adherence in participants, when linked with another first-line anti-hypertensive.

Dr. Serge Engamba, Chief Investigator of OptiZest, GP, Clinical Research Lead at North Norfolk Primary Care and Deputy Specialty Lead at NIHR CRN East of England, commented: “Persistent high blood pressure can increase your risk of a number of serious and potentially life-threatening health conditions, such as heart attacks, strokes, kidney disease and even dementia. It is therefore crucial that doctors and patients work together to achieve optimal management of this condition. This pioneering research study offers an unprecedented opportunity to understand how effectively we can do this using innovative technologies and well-known medicines.”

Dr. Hakim Yadi PhD OBE, CEO & Co-Founder, Closed Loop Medicine, said: “Our dedication to advancing the quality of patient care is exemplified through our partnership with Pharmanovia and the initiation of the OptiZest study. This not only represents a milestone in hypertension management, but also underscores our broader mission to support healthcare systems in improving patient outcomes across diverse therapeutic areas.”

Dr. James Burt, CEO of Pharmanovia, said: “OptiZest speaks to the heart of what we’re trying to do at Pharmanovia, which is to advance healthcare by innovating established medicines; enabling clinicians to efficiently personalise treatments for patients and seek to optimise the balance between efficacy and unwanted side effects. Starting by delivering much needed innovation to hypertension management, this study sets the stage for development and launch of one of the first drug and software combination products for hypertension.”

OptiZest is co-funded by both companies and led by Dr. Serge Engamba, GP and Clinical Research Lead at North Norfolk Primary Care. The study is also being supported by the National Institute for Health and Care Research.