A major £2.2 million ($2.85 million) clinical research grant has been awarded to Yaqrit to fund pivotal trials of its extracorporeal liver support device, DIALIVE (YAQ002), bringing new hope to patients with life-threatening liver failure.
The grant from the UK's National Institute for Health and Care Research (NIHR) will cover clinical and development costs for ALIVER 2.0, the randomized pivotal registration trial aimed at moving the device closer to UKCA and CE mark authorization. The device is designed to treat patients with Acute-on-Chronic Liver Failure (ACLF) grade 2 and 3, a condition characterized by multiorgan failure and high mortality risk.
"The NIHR grant financing for YAQ002 enables Yaqrit to take this life-saving technology forward towards the market, as part of our mission to create value by helping patients with liver failure," said Troels Jordansen, Chief Executive Officer of Yaqrit. "The prestige and resources of NIHR will accelerate Yaqrit's development of YAQ002 bringing new hope to thousands of advanced liver patients who desperately need an effective treatment for ACLF."
Collaborative Research Across Leading UK Centers
The study will be led by co-principal investigators Professor Banwari Agarwal and Dr. Rohit Saha at the Royal Free Hospital, together with Professor Rajiv Jalan at University College London (UCL), Dr. Sameer Patel at Kings College Hospital London, and Dr. Mansoor Bangash at the Queen Elizabeth Hospital, Birmingham. Nine additional UK clinical centers specializing in ACLF treatment will participate in patient recruitment.
The trial's kick-off meeting and first Investigator's meeting were held on March 12, 2025, at the Institute for Liver and Digestive Health, UCL. DIALIVE is being developed by Yaqrit's subsidiary Cytox Life-Sciences.
Addressing a Critical Unmet Need
ACLF affects up to 3.7 million patients with liver cirrhosis globally each year, including approximately 1.9 million grade 2 and 3 patients. The condition carries a devastating mortality rate of 40-80% within 28 days, depending on severity.
Professor Rajiv Jalan, co-principal investigator, Professor of Hepatology from UCL Institute for Liver & Digestive Health and Yaqrit's Founder, emphasized the significance of this development: "This is extremely important news for patients within the UK and beyond with advanced liver disease whose current treatment options are severely limited. Our goal is to demonstrate that we can resolve ACLF more often and/or faster than standard of care, and thereby impact both patients' time in hospital and chances of survival."
Innovative Mechanism of Action
The DIALIVE device works by removing disease-causing toxins from patients' blood, particularly the inflammatory mediators characteristic of ACLF, while simultaneously exchanging dysfunctional albumin for fresh albumin. This approach has already demonstrated promising results in earlier studies.
In a previous Europe-wide clinical trial, ACLF was resolved approximately twice as frequently and significantly more rapidly during the 10-day treatment period in DIALIVE-treated patients compared to those receiving standard-of-care treatments. The device has proven to be a safe and effective way of resolving liver failure by facilitating liver regeneration.
Trial Design and Timeline
The ALIVER 2.0 trial will recruit approximately 70 of the most severely affected patients—those with multiple organ failure following liver disease (ACLF Grade 2 and Grade 3)—who face up to an 80% risk of mortality without liver transplantation.
Following enrollment and a patient recruitment period of around 18 months, patients randomized to receive DIALIVE treatment will undergo up to seven treatment sessions during a 10-day period. The trial will assess rapid co-primary endpoints measured over 10 and 28 days, with results expected in Q1 2027.
Historical Context and Development
The technology behind DIALIVE was invented by Professor Jalan and Professor Nathan Davies, based in the Liver Failure Group at UCL's Institute for Liver and Digestive Health. UCL and Royal Free Hospital researchers first identified acute-on-chronic liver failure as a distinct clinical entity in 2001, leading to the development of DIALIVE. The intellectual property was patented by UCL in 2009 and licensed to Yaqrit, a UCL spinout company.
Potential Impact on Patient Care
For patients with decompensated cirrhosis, median survival falls from more than 12 years for compensated cirrhosis to about two years for the decompensated form. When ACLF develops, the prognosis becomes even more dire, with 58% mortality in the first 90 days.
If successful, the DIALIVE device could transform the treatment landscape for these patients, offering a viable alternative to liver transplantation and potentially reducing mortality rates, hospital stays, and healthcare costs associated with this devastating condition.
