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The study will assess the firm's intensive care liver support system across 13 U.K. centers.
April 1, 2025
By: Michael Barbella
Managing Editor
Yaqrit has been awarded a £2.2 million ($2.85 million) clinical research grant that will fund development of its extracorporeal liver support device (DIALIVE) for treating patients with Acute-on-Chronic Liver Failure (ACLF) grade 2 and 3.
The grant covers the clinical and development costs of ALIVER 2.0, the randomized pivotal registration trial of DIALIVE (YAQ002). The grant is from the United Kingdom’s largest funder of health R&D, the National Institute for Health and Care Research (NIHR), under the Invention for Innovation program.
“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,” Yaqrit CEO Troels Jordansen said. “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 Royal Free Hospital; Prof. Jalan at University College London (UCL); Dr. Sameer Patel at Kings College Hospital London; and Dr. Mansoor Bangash at Queen Elizabeth Hospital, Birmingham. Nine other U.K. clinical centers specializing ACLF treatment will also recruit patients.
Globally, ACLF affects up to 3.7 million patients annually with liver cirrhosis, including roughly 1.9 million grade 2 and 3 patients. Depending on severity, about 40% to 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 treatments.
“This is extremely important news for patients within the U.K. and beyond with advanced liver disease whose current treatment options are severely limited,” said Yaqrit Founder Rajiv Jalan, co-principal investigator and professor of Hepatology at the UCL Institute for Liver & Digestive Health. “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 seven treatment sessions.
Annually, in more than 10 million patients worldwide, liver cirrhosis progresses from an asymptomatic (compensated) form to the decompensated form at which point the liver can no longer undertake its usual functions. Thus, ammonia levels in the blood can increase and have a toxic impact on the brain, causing hepatic encephalopathy. Patients with decompensated cirrhosis also become highly susceptible to bacterial infections due to immune dysfunction. Multiple organ failure becomes more common. These factors lead to increased morbidity with median survival falling from more than 12 years for compensated cirrhosis to about two years for decompensated cirrhosis.
ACLF is a life-threatening syndrome affecting patients with cirrhosis, characterized by intense systematic inflammation, organ failure, and high short-term mortality. Globally, around 35% of 10.6 million patients with acutely decompensated cirrhosis have ACLF, rising to 65% among South Asia populations. Current outcomes for patients remain poor, with 58% mortality in the first 90 days.
Yaqrit is a clinical-stage company discovering and developing treatments for patients with advanced liver disease at high risk of hospitalization and death. Yaqrit’s pipeline includes three therapeutics at phase 2-3 of development and two medical devices providing acute and chronic treatments for advanced cirrhosis and acute-on-chronic liver failure where there is an urgent need for more effective treatments.
The National Institute for Health and Care Research (NIHR) aims to improve the health of U.K. residents. NIHR is funded by the Department of Health and Social Care and its work in low and middle income countries is principally funded through U.K. international development funding from the U.K. government.
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