Yaqrit Receives NIHR Grant for DIALIVE Liver Support Trials

Yaqrit, a clinical-stage company focused on developing treatments for advanced liver diseases, has announced a significant milestone in its efforts to address severe liver conditions. The company has secured a £2.2 million ($2.85 million) clinical research grant from the National Institute for Health and Care Research (NIHR) to advance the development of DIALIVE (YAQ002), an extracorporeal liver support device. This funding is a critical step in obtaining UKCA and CE mark authorization, bringing the device closer to market availability.

DIALIVE is designed to treat patients suffering from Acute-on-Chronic Liver Failure (ACLF) grade 2 and 3. ACLF is a life-threatening condition in patients with cirrhosis, characterized by multiorgan failure and a high risk of mortality. The device functions by cleansing the blood of disease-causing toxins, particularly those responsible for ACLF-related inflammation, and by replacing damaged albumin with healthy albumin. This innovative approach facilitates liver regeneration, offering a potential lifeline for patients who otherwise face a grim prognosis.

The grant will support the ALIVER 2.0 trial, a pivotal registration study for YAQ002. This trial involves a consortium of 13 UK medical centers, including the Royal Free Hospital, University College London (UCL), Kings College Hospital London, and Queen Elizabeth Hospital Birmingham. Nine other specialized centers will participate in patient recruitment. The trial's co-principal investigators include Prof Banwari Agarwal, Dr Rohit Saha, Prof Jalan, Dr Sameer Patel, and Dr Mansoor Bangash.

Globally, ACLF impacts up to 3.7 million patients with liver cirrhosis annually, with an alarming mortality rate of 40-80% within 28 days, depending on severity. DIALIVE has demonstrated its effectiveness in previous European studies, resolving ACLF more rapidly and frequently than standard treatments over a 10-day period. This success offers a glimmer of hope for patients with advanced liver disease, whose current treatment options are severely limited.

The trial, expected to yield results by the first quarter of 2027, aims to recruit approximately 70 patients experiencing multiple organ failure due to liver disease (ACLF Grade 2 and 3). These patients are at a high risk of death without a liver transplant. During the trial, those randomized to receive YAQ002 will undergo up to seven treatment sessions over a 10-day period. The trial's commencement was marked by an initial meeting at the Institute for Liver and Digestive Health at UCL.

Yaqrit's CEO, Troels Jordansen, emphasized the importance of the NIHR grant in pushing this life-saving technology towards market readiness. The collaboration with NIHR will accelerate Yaqrit's mission to bring effective treatment options to patients with liver failure, creating a positive impact on their survival chances.

ACLF is a severe condition associated with cirrhosis, characterized by systemic inflammation, organ failure, and a high mortality rate. Current treatment outcomes remain poor, with significant mortality within the first 90 days. Yaqrit's development of YAQ002 represents a crucial advancement in addressing this urgent medical need, potentially transforming care for millions of patients worldwide who suffer from advanced liver diseases.