Invizius has announced in a press release that the first two patients have been treated with its H-Guard priming solution in the company’s first-in-human Phase 1 clinical study at the National Institute for Health and Care Research (NIHR) Manchester clinical research facility (CRF).
The study, which is investigating the safety and tolerability of Invisius’s lead product, H-Guard, in patients receiving haemodialysis who are vulnerable to dialysis-induced immune activation. Immune activation, Invisius states, occurs when a patient’s blood comes into contact with foreign surfaces in the dialysis circuit. This can then lead to excessive inflammation, coagulation, vascular and organ damage, and other deleterious outcomes. The purpose of H-Guard is to prevent this from occurring; it is flushed through the dialysis machine prior to the treatment beginning, with the aim of preventing serious complications by “attenuating the patient’s immune response to the dialysis procedure”.
Following the treatment of these first two patients, the UK Medicnes and Healthcare products Regulatory Agency (MHRA) approved continuation of the study, based off the safety and performance data from these patients. Moving forward, the trial will now recruit up to a further eight patients to the study, which is being led by Sandip Mitra (Manchester Royal Infirmary, Manchester, UK) and co-investigators Leonard Ebah (Manchester Royal Infirmary, Manchester, UK) and Duha Ilyas (Manchester Royal Infirmary, Manchester, UK). Mitra said of the trial that “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.”
Commenting on this news, Invizius chief executive officer, Richard Boyd, 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”.
