Completed Cancer Digestion, Kidneys & Other Organs

Proof of Concept clinical trial for Akaza Biosciences’ Resatorvid in Acute on Chronic Liver failure patients

Funder InnovateUK (part of UKRI)
Recipient organisation Akaza Bioscience
Funding £2.7M
Period Mar 2019 — Aug 2021

In plain English

AI plain-English summary

Every year, roughly one in three patients who arrive at hospital with acute-on-chronic liver failure (ACLF) will die within 28 days. ACLF is a sudden, severe worsening of existing chronic liver disease, often triggered by an infection or bleeding, that rapidly leads to organ failure. There are currently no approved treatments—doctors can only treat the trigger and provide supportive care. This trial tests Resatorvid, a drug originally developed for sepsis, as the first targeted therapy for ACLF. Resatorvid works by blocking a specific immune receptor that drives the runaway inflammation responsible for organ damage in ACLF. Akaza Biosciences is now moving the drug into a Phase 2 proof-of-concept trial in ACLF patients. If the trial succeeds, Resatorvid could become the first licensed treatment for ACLF, potentially securing Orphan Drug Designation and reaching the market by 2022. That would give clinicians a tool to directly interrupt the disease process, rather than simply managing its consequences.

View original technical description
Acute-on-chronic liver failure (ACLF) is a syndrome characterized by acute deterioration of existing chronic liver disease, progressing to organ failure and associated with a high mortality. It usually results after a precipitating event such as trauma, surgery, variceal bleeding, or infection that may directly exaggerate liver injury. There are no approved treatments for the condition. Management of ACLF focuses on rapid treatment of the precipitating event when this can be identified and the delivery of supportive care. The 28-day mortality in patients presenting with ACLF has been estimated to be approximately 34%. RESATORVID is a new first in class therapeutic approach with previous promising efficacy and safety in sepsis clinical trials. It has a unique way of working, and there is good evidence to suggest it will provide the first ever effective and targeted treatment for ACLF patients. Akaza Biosciences Ltd intend to progress Resatorvid into a Phase 2 clinical proof-of-concept trial in ACLF patients. Success would lead to an Orphan Drug Designation and eventual registration, and market availability in 2022\.

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Related Research

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Extra-corporeal liver cross-circulation in the treatment of acute-on-chronic liver failure: a safety and feasibility study
Novel treatment of acute on chronic liver failure using synergistic action of g-csf and tak-242
Macrophage Therapy for Acute Liver Failure
Evaluation of DIALIVE, a novel Liver Dialysis Device for the treatment of patients with Acute on Chronic Liver Failure Grade 3
Development of DIALIVE, a novel Liver Dialysis Device for the treatment of patients with Acute on Chronic Liver Failure (ACLF)

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