Scottish biotechnology company Invizius has completed the first-in-human Phase 1 clinical trial of its dialysis priming solution, H-Guard.
H-Guard is a second-generation complement regulator with anti-inflammatory and anti-coagulatory properties.
Invizius, a spin-out from the University of Edinburgh, has designed the product to form a coating on the dialysis filter and tubing during the priming process.
The Phase 1 study involved eight patients who were treated at the National Institute for Health and Care Research (NIHR) Manchester Clinical Research Facility (CRF) in the UK.
The trial was held at the NIHR Manchester CRF located at the Manchester Royal Infirmary (MRI), which is part of the Manchester University NHS Foundation Trust.
Invizius secured approval from the UK Medicines and Health Regulatory Agency (MHRA) in August 2023 to start the Phase 1 trial. The first patient was treated in February 2024.
The study was led by Sandip Mitra along with Leonard Ebah and Duha Ilyas as co-investigators.
It assessed the safety of H-Guard in patients subjected to haemodialysis, a population susceptible to immune activation induced by dialysis.
Prior to the treatment, H-Guard is flushed through the dialysis machine, creating a coating on all blood-exposed surfaces.
Patients underwent a single treatment with the H-Guard product, and both pre- and post-treatment evaluations showed its safety and tolerability.
Invizius CEO Magnus Nicolson said: “It has been a pleasure to work with Professor Mitra and his team to demonstrate the safety of H-Guard on dialysis patients.
“This is an important milestone for H-Guard and Invizius, allowing us to progress into a larger efficacy study showing the clinical benefits of controlling complement activation in CRRT and a number of extracorporeal systems.”
The results will support the next phase of development which includes a Phase 2b study for acute kidney injury (AKI).
In the study, the H-Guard coating will be applied to the continuous renal replacement therapy (CRRT) filter used in intensive care units (ICUs).
