525-patient trial intends to assess ‘complement activation’ during HD in patients with end-stage renal failure

Invizius – a company focusing on second-generation therapies for autoimmune conditions – has announced that the 300th patient has been recruited to its ‘angry blood’ study.

The novel kinetic research has been designed to identify patients with elevated complement responses during haemodialysis (HD), also known as ‘angry blood’. It has also been developed to establish those individuals who may have a greater risk of serious cardiovascular complications – the major cause of mortality among HD patients.

The 525-patient trial intends to assess ‘complement activation’ during HD in patients with end-stage renal failure and its wider link to the patient’s risk of serious complications during dialysis.

Meanwhile, dialysis patients from partnering institutions such as Royal Preston Hospital, Salford Royal NHS Foundation Trust and Liverpool Royal Infirmary, will be participating in the ongoing study. This network will allow Invizius to stratify the patient population in preparation for the upcoming first-in-human study of its H-Guard priming solution.

Subject to approvals by the Medicines and Healthcare Products Regulatory Agency (MHRA), this research will begin later in 2023.

Dr Andy Herbert, chief technology officer at Invizius, elaborated: “We are only halfway through our ‘angry blood’ study but the kinetic data on complement and immune activation we are obtaining is providing valuable insights into the problems faced by a number of dialysis patients.”

He added: “Complement activation is one of the fastest and most powerful biological responses known and collecting kinetic samples at this scale has never been attempted before. Therefore, we are getting a unique insight into what is happening to patients with ‘angry blood’ and how H-Guard may operate in the clinic.”

Richard Boyd, chief executive officer at Invizius, concluded: “We are delighted with the progress of this unique, smart clinical study which will allow us to identify patients for our first-in-human clinical study of H-Guard. H-Guard has the potential to address the serious complement-driven complications of haemodialysis. By stratifying patients and treating those most at risk, we can ensure H-Guard’s efficacy while reducing cost- and time-to-market.”

‘Angry blood’ typically occurs in over 20% of patients undergoing HD, making them more susceptible to heart disease, risk of stroke, damage to blood vessels and a very poor patient prognosis.