Closed Loop Medicine Ltd, a TechBio company developing combination prescription drug plus software therapy products that deliver personalised dose optimisation and Pharmanovia, a global pharmaceutical company that commercialises novel medicines and expands the lifecycle of established medicines, have initiated the collaborative OptiZest study (NCT06372470).
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.
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 in treating this common — but often fatal — disease.
Addressing hypertension on a personal level
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 (4).
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.
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.”