With patient recruitment now underway, the trial will investigate whether patients with hypertension can improve blood pressure control at home while receiving a personalized dose of Zestril (lisinopril).
According to both companies, the proof-of-concept study marks a significant milestone in Closed Loop Medicine and Pharmanovia’s co-development partnership.
This initiative focuses on developing and launching a combination drug and software therapy for hypertension in the UK, with plans for a global rollout and expansion into other therapeutic areas.
Dr. Hakim Yadi, CEO & co-founder of 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.”
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 per 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 optimization technology and Pharmanovia’s established medicine brands, the companies aim to support patients and healthcare professionals through the development of an ‘innovative’ intervention.
Dr. James Burt, CEO of Pharmanovia, added: “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 personalize treatments for patients and seek to optimize 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.”
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 control blood pressure, minimize side effects, and support medication adherence in participants.
Dr. Serge Engamba, chief investigator of OptiZest, 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.”
