Yaqrit secures NIHR grant for pivotal trials of its liver support device, DIALIVE, for patients with
- 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.
Contact Company
Troels Jordansen
Email: Troels@Yaqrit.com
Tel: +31 6 1834 5326
Contact Investors
Mary-Ann Chang
Email: Mary-Ann@Yaqrit.com
Tel: +44 7483 284 853
About Yaqrit
Yaqrit is a clinical-stage company discovering and developing innovative treatments for patients with advanced liver disease at high risk of hospitalization and death. Yaqrit's pipeline includes three novel 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. More information is available at www.Yaqrit.com
About Decompensated Cirrhosis
In over 10 million patients worldwide per year, liver cirrhosis progresses from an asymptomatic (compensated) form to the decompensated form at which point the liver can no longer undertake its usual functions. As a result, levels of ammonia 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 because of 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.
About Acute-on-Chronic Liver Failure
Acute-on-Chronic Liver Failure (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.
About NIHR
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
- Funding high quality, timely research that benefits the NHS, public health and social care;
- Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
- Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
- Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
- Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
- Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK international development funding from the UK government.
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