A New Dawn for Haemodialysis: Invizius Receives MHRA Approval for Ground-breaking H-Guard® Clinical Study

The Biotech Giant’s Innovation, H-Guard®, Seeks to Mitigate Complement-Driven Complications in Haemodialysis Patients

Key Takeaways

  • The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval to Invizius Limited for a first-in-human clinical trial of H-Guard®.
  • H-Guard® has been developed to address serious inflammatory complications associated with haemodialysis.
  • The study is set to be conducted at Manchester University Hospitals NHS Foundation Trust.
  • The goal of the research is to improve the quality of life for millions of haemodialysis patients worldwide.
  • H-Guard® is a promising product that has the potential to revolutionize treatments for both chronic and acute kidney failure, along with other extra-corporeal treatments.

About Invizius Limited

Invizius Limited is a forward-thinking biotechnology company that specializes in the development of second-generation therapies aimed at mitigating a variety of complement-driven autoimmune and inflammatory disorders. Born out of over a decade of research by Dr. Andy Herbert, Invizius’ proprietary approach leverages a unique mechanism of action to enhance the body’s own complement regulators. The goal is to effectively downregulate autoimmune responses while still preserving antimicrobial protection. The company’s groundbreaking product, H-Guard®, is designed to combat serious complement-driven complications related to haemodialysis.

The Dawn of H-Guard®: A Promising Step Forward

In a significant stride toward improving the quality of life for millions of haemodialysis patients worldwide, Invizius has received approval from the MHRA to begin the first-in-human clinical trial of H-Guard®. This groundbreaking product will be evaluated for its safety and efficacy to address serious complement-driven complications of haemodialysis. As Richard Boyd, CEO of Invizius, expressed, “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.”

How H-Guard® Works

H-Guard® functions as a potent anti-inflammatory and anti-coagulant second-generation complement regulator. It works by coating the dialysis filter and tubing during the priming process. This process suppresses complement activation on the surfaces of the extracorporeal circuit by recruiting and enhancing the patient’s own natural complement modulator, Factor H, while still maintaining effective infection control.

Dr. Andy Herbert, Chief Technology Officer of Invizius, shared his excitement about the breakthrough: “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.”

Implications and Future Prospects

The results of this first-in-human study of H-Guard® will lay the groundwork for its future clinical development in treating patients with both chronic and acute kidney failure. Moreover, it may prove beneficial in other extra-corporeal treatments, such as ECMO and cardiopulmonary bypass.

As Invizius steps into a new chapter with this study, the potential implications for haemodialysis treatment are vast and exciting. With the committed effort of their dedicated team and the promising potential of H-Guard®, Invizius is carving a path toward revolutionizing the management of complement-driven complications, thereby paving the way for a better quality of life for haemodialysis patients globally.

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