Invizius has announced that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to commence its first-in-human clinical study of its lead product, H-Guard. The study will be conducted at the Manchester University Hospitals NHS Foundation Trust (MFT) and will be led by Sandip Mitra (Manchester University NHS Foundation Trust, Manchester, UK) and co-investigators Leonard Ebah (Manchester University NHS Foundation Trust) and Dr Duha Ilyas (Manchester Royal Infirmary, Manchester).
The study will investigate the safety and tolerability of H-Guard as a potential solution to address serious complement-driven inflammatory complications of haemodialysis. Patients from the ongoing ‘Angry Blood’ stratification study who have been identified with elevated complement responses during haemodialysis will be contacted and invited to participate in the trial. According to independent research from the University Medical Centre Groningen (Groningen, The Netherlands) patients with elevated complement responses during dialysis are at greater risk of serious cardiovascular complications which is the major cause of mortality in haemodialysis patients.
Richard Boyd, CEO of Invizius, said: “The MHRA approval marks a significant milestone for Invizius as we progress into clinical development with our lead product H-Guard. We aim to improve quality of life for the millions of patients worldwide receiving haemodialysis and provide a life-changing solution to address complement-driven complications which results in a poor patient prognosis. We look forward to sharing results in due course.”
Andy Herbert, chief technology officer at the company, added: “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.”
H-Guard is described in a press release as “a highly potent anti-inflammatory and anti-coagulant 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”.
Results from the first-in-human study will enable future clinical development of H-Guard in patients with chronic and acute kidney failure, and in other extra-corporeal treatments, such as ECMO and cardiopulmonary bypass, the company states.