First-in-human study to be undertaken at the Manchester University Hospitals NHS Foundation Trust.
Invizius, a company concentrating on second-generation therapies for autoimmune and inflammatory conditions, has announced that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to begin a clinical trial of its H-Guard priming solution.
The product is an anti-inflammatory and anti-coagulant second-generation regulator that coats the dialysis filter and tubing during the priming processes. It has been developed to suppress complement activation on the extracorporeal circuit’s surfaces by effectively boosting the patient’s own modulator, Factor H, while still allowing infection control.
The first-in-human study will be undertaken at the Manchester University Hospitals NHS Foundation Trust and will be led by Professor Sandip Mitra and co-investigators Dr Leonard Ebah and Dr Duha Ilyas.
The research will investigate the tolerability and safety of H-Guard as a possible solution to serious complement-driven inflammatory complications of haemodialysis (HD).
With this considered, patients from the ongoing ‘Angry Blood’ stratification trial – specifically those who have been identified with elevated complement responses during HD – will be invited to participate in the vital research.
Meanwhile, research from the University Medical Centre Groningen in Holland revealed that patients with elevated complement responses during dialysis are at greater risk of serious cardiovascular complications – a major cause of mortality among individuals living with HD.
Dr Andy Herbert, chief technology officer at Invizius, explained: “It is exciting that scientific research that my colleagues and I have made over a decade ago has translated into a potentially life-changing treatment which is now moving into the clinic. This is the culmination of years of hard work by our dedicated team.”
Richard Boyd, chief executive officer at Invizius, reflected: “The MHRA approval marks a significant milestone for Invizius as we progress into clinical development with our lead product H-Guard.”
He concluded: “We aim to improve the quality of life for the millions of patients worldwide receiving haemodialysis and provide a life-changing solution to address complement-driven complications which result in a poor patient prognosis. We look forward to sharing results in due course.”