Invizius completes first-in-human dialysis trial to quell ‘angry blood’

Invizius has completed a first-in-human study of its approach to taming the immune system’s overreaction to dialysis—with the goal of addressing the complications that can come with “angry blood.”

While you would normally want a zealous white blood cell to attack any newcomers to the body, to protect it against infections and the like, heightened inflammation can take its toll during hemodialysis. 

As the living blood makes its way through the machine, every surface is a surface that triggers the foreign-body response: From the cells' point of view, none of it should be there.

Enter Invizius’ H-Guard priming solution, which is run through the machine before each procedure. It coats the insides with a layer of proteins that effectively camouflage the dialysis hardware from the immune system—stealing a trick from certain bacteria that are capable of evading white blood cells, without triggering the cascading inflammatory reactions known as the complement system.

Late last month, the Scotland-based company—and former Fierce 15 winner—announced that its first eight patients had been successfully treated in a phase 1 study. Analyses before and after dialysis showed that the blood filtration process worked as expected.

Its next step will be to perform a phase 2b trial of hospitalized patients with acute kidney injuries, looking to see if H-Guard can lower the amount of time spent in the ICU or reduce renal damage from the immune system’s reactions to dialysis.

“This is an important milestone for H-Guard and Invizius, allowing us to progress into a larger efficacy study showing the clinical benefits of controlling complement activation in [continuous renal replacement therapy] and a number of extracorporeal systems,” CEO Magnus Nicolson said in a statement. The priming solution is also being studied preclinically for use during heart bypass procedures and in other life support systems.

A previous biomarker analysis study by the company screened blood samples from over 350 participants that undergo routine hemodialysis and found that patients can be categorized by their immune reactions to the procedure. 

While chronic, low-grade inflammation is common among dialysis patients, those with the strongest responses can carry higher risks of developing serious complications—such as blood clots, organ damage or a wide range of other conditions—and may benefit the most from the addition of a product like H-Guard. 

Dubbed “angry blood,” Invizius estimates that about one-in-five dialysis patients may be susceptible to the overreactions, out of the more than 3 million people worldwide who undergo the procedure multiple times per week.

According to Invizius, the results of the biomarker study won “best abstract” last month at the annual meeting of the European Renal Association in Stockholm, as presented by Duha Ilyas, a clinical research fellow at the Manchester Royal Infirmary, part of the Manchester University NHS Foundation Trust and the site of the first-in-human trial.

“This is the largest kinetic analysis of complement activation in routine haemodialysis (HD) ever undertaken in [the U.K.],” said study leader Sandip Mitra, a professor of renal medicine at the Manchester NHS trust. “Our results indicate patient-specific complement activation associated with inflammatory response during routine haemodialysis. Reduction in complement activation in HD may yield significant clinical outcome benefits.”

The company previously raised £5.3 million in a 2021 series A round, joined by Mercia, Downing Ventures, Old College Capital, Scottish Enterprise, Solvay Ventures and Calculus Capital.