Invizius’s Pioneering Dialysis Product H-Guard® Completes First In-Human Clinical Study

• Study demonstrated safety and tolerability of H-Guard®, a second generation complement regulator, designed to address serious immune system-driven complications of dialysis.
• Encouraging biomarker data positions H-Guard for upcoming Acute Kidney Injury (AKI) trial focused on reducing complement mediated renal tubule cell damage during Continuous Renal Replacement Therapy (CRRT).

22 May 2024 – Invizius Limited (“Invizius”), a biotechnology company developing breakthrough treatments for patients on dialysis, is pleased to announce that eight patients have been successfully treated at the National Institute for Health and Care Research (NIHR) Manchester Clinical Research Facility (CRF) with pioneering product, H-Guard® Priming Solution, in the company’s first-in-human Phase 1 clinical study.

The study was conducted at the NIHR Manchester CRF located at the Manchester Royal Infirmary (MRI), part of the Manchester University NHS Foundation Trust, and is led by Professor Sandip Mitra and co-investigators, Dr Leonard Ebah and Dr Duha Ilyas.

The study is investigating the safety and tolerability of the pioneering product, H-Guard®, in patients undergoing haemodialysis (HD) who are vulnerable to dialysis-induced immune activation. Immune activation occurs when a patient’s blood comes into contact with foreign surfaces in the dialysis circuit, which can result in excessive inflammation, coagulation, vascular and organ damage and other adverse consequences. H-Guard is flushed through the dialysis machine; coating all blood exposed surfaces, prior to commencing treatment. The aim is to prevent serious complications by attenuating the patient’s immune response to the dialysis procedure.

The successful trial involved a single treatment with H-Guard® with pre and post treatment evaluations demonstrating the safety and tolerability of the H-Guard® product.  Dialysis, the removal of toxins from the blood by filtration, worked as normal when the product was attached to the filter.  The next step in the trials is the design of a Phase2b study for Acute Kidney Injury (AKI) where the Continuous Renal Replacement Therapy (CRRT) filter in an Intensive Care Unit (ICU) is coated with H-Guard®. This study aims to demonstrate a reduction in complement mediated renal tubule damage resulting in less time spent in the ICU and prevention of Chronic Kidney Disease (CKD) developing.

Dr Magnus Nicolson, Chief Executive Officer of Invizius, 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.”

Professor Sandip Mitra, Consultant Nephrologist and Professor of Renal Medicine at Manchester University NHS Foundation Trust, commented: “As our aim is to improve the outcomes of patients on dialysis, we are very encouraged by the results of the H-Guard® trial. This week at the ERA in Stockholm, Dr Ilyas Duha will be presenting data from Invizius sponsored trial CompAct-HD. This is the largest kinetic analysis of complement activation in routine haemodialysis (HD) ever undertaken in UK. Our results indicate patient specific complement activation associated with inflammatory response during routine haemodialysis. Reduction in complement activation in HD may yield significant clinical outcome benefits.”

H-Guard® is a potent anti-inflammatory and anti-coagulatory, second generation, complement regulator which coats the dialysis filter and tubing during the priming process. This is designed to suppress complement activation on the extracorporeal circuit’s surfaces by recruiting and enhancing the patient’s own, natural complement modulator, Factor H, whilst still allowing effective infection control.

Invizius collaborated with the clinical trial organisation, TCRSolutions who managed the trial on their behalf. 

Invizius will be present at the 61^st ERA Congress taking place in Stockholm May 23-26, 2024.