- Trial to assess intensive care liver support system across 13 UK centers, led by UCL, Royal Free, Kings College and Queen Elizabeth Birmingham
- Rapid co-primary endpoints measured over 10 and 28 days; readout Q1 2027
- Aims to resolve life-threatening condition and impact survival
LONDON, March 21, 2025 (GLOBE NEWSWIRE) -- Yaqrit, a late clinical-stage company developing life-saving treatments for advanced liver diseases, announced today a major £2.2 million ($2.85 million) clinical research grant that will fund the development of its extracorporeal liver support device, DIALIVE (YAQ002) for advanced liver disease patients and move the device closer to UKCA and CE mark for marketing authorization. The device treats patients with Acute-on-Chronic Liver Failure (ACLF) grade 2 and 3, a life-threatening condition affecting patients with cirrhosis characterized by multiorgan failure and high risk of mortality.
The grant covers the clinical and development costs of ALIVER 2.0, the randomized pivotal registration trial of Yaqrit’s YAQ002. The grant is from the UK’s largest funder of health R&D, the National Institute for Health and Care Research (NIHR), under their Invention for Innovation program (Award: NIHR206537).
“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.”
Leading the study as co-principal investigators are Prof Banwari Agarwal and Dr Rohit Saha at the Royal Free Hospital, together with Prof 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 other UK clinical centers specializing in the treatment of ACLF will also be involved in the recruitment of patients.
Globally, ACLF affects up to 3.7 million patients with liver cirrhosis each year, including around 1.9 million grade 2 and 3 patients. Depending on severity, about 40-80% of patients die within 28 days. YAQ002 works by removing disease-causing toxins from patients’ blood, notably the ACLF-signatures of inflammatory mediators, and by exchanging dysfunctional albumin for fresh albumin. The device has already proved to be a safe and rapid way of resolving liver failure by allowing liver regeneration to occur. In a successful earlier Europe-wide study, ACLF was resolved approximately twice as frequently and significantly more rapidly during the 10-day treatment period in YAQ002-treated patients as in those on standard-of-care treatments.
“This is extremely important news for patients within the UK and beyond with advanced liver disease whose current treatment options are severely limited,” said Rajiv Jalan, co-principal investigator, Professor of Hepatology from UCL Institute for Liver & Digestive Health and Yaqrit’s Founder. “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.”
Results of the trial are expected in Q1 2027, following formal ethical clearance and a patient recruitment period of around 18 months. The trial will recruit about 70 of the sickest patients -- those with multiple organ failure following liver disease (ACLF Grade 2 and Grade 3) -- who have a high risk (up to 80%) of dying unless they receive a liver transplant. Following enrollment, during a 10-day treatment period, those patients randomized to receive YAQ002 will receive up to 7 sessions of treatment.
The kick-off meeting and first Investigator’s meeting were held on the 12th March 2025 at the Institute for Liver and Digestive Health, UCL. YAQ002 is being developed by Yaqrit’s subsidiary Cytox Life-Sciences.