The UK MHRA has given its approval for the continuation of the trial upon receiving the first two patients' safety and performance data
Invizius starts Phase 1 clinical study of its H-Guard dialysis product. (Credit: Thomas G. from Pixabay)
Invizius, a biotechnology company engaged in developing treatments for dialysis patients, has reported the treatment of the first two patients in the first-in-human (FIH) Phase 1 trial of its lead dialysis product, H-Guard Priming Solution.
H-Guard is a second-generation complement regulator that coats the dialysis filter and tubing during priming. It is said to have strong anti-inflammatory and anticoagulatory properties.
The patients were treated at the National Institute for Health and Care Research (NIHR) Manchester Clinical Research Facility (CRF) in the UK.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has given its approval for the continuation of the trial upon receiving the first two patients’ safety and performance data.
This trial is assessing the safety and tolerability of H-Guard for use in patients receiving haemodialysis (HD) who may be at risk for immune activation from dialysis.
H-Guard is administered through the dialysis machine before treatment begins. This is aimed at reducing the patient’s immune response to the dialysis procedure and thereby preventing potential serious complications.
Invizius CEO 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.”
H-Guard is intended to enhance and recruit the patient’s natural complement modulator, Factor H.
According to Invizius, this reduces complement activation on the extracorporeal circuit surfaces while maintaining efficient infection management.
Moreover, the solution facilitates potential applications in other extracorporeal treatments, such as extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass.
Invizius is also developing a second product to extend the period that patients can sustain home-based, peritoneal dialysis.