Invizius Receives MHRA Approval to Commence First-in-Human Clinical Study of H-Guard® Priming Solution

• H-Guard® will be evaluated for its safety and efficacy to address serious complement driven complications of haemodialysis

GLASGOW, Scotland, Aug. 1, 2023 /PRNewswire/ -- Invizius Limited ("Invizius"), a biotechnology company developing second generation therapies for a range of complement-driven autoimmune and inflammatory disorders, is pleased to announce that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to commence its First-in-Human clinical study of lead product, H-Guard. The study will be conducted at the Manchester University Hospitals NHS Foundation Trust (MFT) and will be led by Professor Sandip Mitra and Co-investigators Dr Leonard Ebah and Dr Duha Ilyas.

The study will investigate the safety and tolerability of H-Guard as a potential solution to address serious complement-driven inflammatory complications of haemodialysis (HD). Patients from the ongoing 'Angry Blood' stratification study who have been identified with elevated complement responses during HD will be contacted and invited to participate in the trial. According to independent research from the University Medical Centre Groningen (Netherlands) patients with elevated complement responses during dialysis are at greater risk of serious cardiovascular complications which is the major cause of mortality in HD patients[1].

Richard Boyd, Chief Executive Officer 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."

Dr Andy Herbert, Chief Technology Officer, 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 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.

About Invizius

Invizius is developing a portfolio of second generation complement therapies to address a range of autoimmune and inflammatory diseases. Invizius' proprietary approach was born out of over ten years of research by Dr Andy Herbert into how pathogenic microbes evade the human complement system. The novel mechanism of action enhances the activity of the body's own complement regulators to effectively downregulate autoimmune responses while maintaining antimicrobial protection. The approach of regulating, rather than inhibiting, complement should confer higher patient safety and effectiveness compared to first generation complement therapies. The lead product, H-Guard, addresses serious complement-driven complications of haemodialysis, and enables additional indications in other extra-corporeal treatments (ECMO, cardiopulmonary bypass). A second development targets fibrotic complications of peritoneal dialysis, and the company intends to expand development to treat other complement-driven diseases and disorders.

The company is working with Key Opinion Leaders from University of Manchester NHS Trust, Karolinska Institutet, University of Heidelberg, University Medical Centre Groningen, University of Oxford, and University of Strathclyde. It is backed by Mercia, Downing, Calculus, and Solvay, a corporate VC. Other investors include Edinburgh University's Old College Capital fund, Scottish Enterprise, and well-known life science investor, Dr Jonathan Milner.

 For more information on Invizius, please visit: www.invizius.com

[1] Poppelaars F, et al. Intradialytic Complement Activation Precedes the Development of Cardiovascular Events in Hemodialysis Patients. Front Immunol. 2018 Sep 13;9:2070