Invizius Treats First Patients in First-In-Human Phase 1 Clinical Study of Lead Dialysis Product H-Guard®

• First patients treated with H-Guard® at the National Institute for Health and Care Research Manchester Clinical Research Facility
• MHRA approves continuation of Invizius’s first-in-human clinical study following a prearranged two-patient safety and performance review
• Study is investigating safety and tolerability of H-Guard®, a second generation complement regulator, to address serious immune system-driven complications of dialysis

Glasgow, Scotland, 7 February 2024 – Invizius Limited (“Invizius”), a biotechnology company developing breakthrough treatments for patients on dialysis, is pleased to announce that the first two patients have been treated at the National Institute for Health and Care Research (NIHR) Manchester Clinical Research Facility (CRF) with lead product, H-Guard® Priming Solution, in the Company’s first-in-human Phase 1 clinical study.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved continuation of the study, following the submission of safety and performance data from the first two patients. Up to eight more patients will be recruited to the CRF, the only UK site to participate in the study. The study is being conducted at the NIHR Manchester CRF 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 lead 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 prior to commencing treatment and aims to prevent serious complications by attenuating the patient’s immune response to the dialysis procedure.

Richard Boyd, Chief Executive Officer of Invizius, said: “The treatment of the first patients with our lead product, H-Guard, is a major milestone for Invizius as we enter clinical development with our first-in-human Phase 1 study at the Manchester Clinical Research Facility. We are pleased to have received MHRA approval to continue the study after a prearranged, two-patient safety and performance review, and we are excited by the potential of H-Guard to improve the treatment paradigm of patients on dialysis.”

Professor Sandip Mitra, Consultant Nephrologist and Professor of Renal Medicine at Manchester University NHS Foundation Trust, commented: “Our aim is to improve the outcomes of patients on dialysis. We are continuing this study to seek more safety and performance data necessary to demonstrate H-Guard’s potential and to direct future clinical applications and testing.”

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.