Dialive™ is a patented dual filtration system that can be delivered using a kidney dialysis machine. It includes two specialized filters – one to remove blood-borne products of liver failure, such as cell debris and bacterial toxins, and the other to remove circulating albumin that is damaged and toxic when the liver fails. The damaged albumin is then replaced with fresh albumin. 

ACLF is a condition characterised by systemic inflammation and is associated with single or multiple organ failure. The result is a high short-term risk of death. In ACLF patients, 28-day mortality can be as high as 88.9%i depending on the number of organ failures. The safety and tolerability primary endpoints of the randomized controlled trial were met. There were no significant differences in serious adverse events between the control and study group. In addition, more patients receiving Dialive™ treatment resolved to a “no-ACLF” status than the control arm, and they resolved faster. Improvement in the Dialive™-treated patients was also seen in a panel of biomarkers thought to be associated with systemic inflammation and organ failure in ACLF. These showed statistically significant benefits for patients on Dialive™ compared to the control arm, 10 days after the start of the treatment protocol of three to five sessions of 8 to 12 hours each. The conclusions set forth in this announcement remain subject to finalizing the remaining data analysis, the statistical and clinical study report and, therefore may change.

Professor Rajiv Jalan, Professor of Hepatology at UCL, Scientific Director of EF CLIF, Coordinator of the ALIVER project and an inventor of Dialive™, commented: “I am delighted to share these incredibly promising data which indicate that Dialive has the potential to significantly change the outlook for ACLF patients by reversing the course of their disease. Currently, there are no approved therapies for ACLF and around 40% of patients die within three months of hospital admission. We believe Dialive could potentially be a much-needed solution and Yaqrit is planning to further trials to facilitate the product’s path to regulatory approval. I acknowledge gratefully the support of the EU’s H2020 grant, the huge contribution of all our collaborators and the patients who have been instrumental in the progress the Consortium has made in allowing the development of this treatment that has the potential to save the lives of patients with liver failure.”

Yaqrit Ltd., the Dialive™ intellectual property and commercial rights holder and member of the ALIVER Consortium, intends to carry out a randomized pivotal trial in 2021 across Europe. Plans are also underway to pursue a US regulatory pathway. Full results from the trial will also be submitted for peer reviewed publication in a leading scientific journal.