The CARBALIVE project

The aim of the CARBALIVE project is to further develop and validate a novel macroporous carbon adsorbent (Yaq-001) capable of removing bacterial endotoxin and other metabolic toxins relevant to the progression of bacterial translocation and endotoxemia in patients with cirrhosis and NAFLD. The consortium represents an established industry-academia partnership investigating the feasibility of this approach, which goes beyond the state of the art associated with current adsorbents in breadth and capacity to target the removal of these bacterial toxins. The outcome will be a new therapeutic strategy for the treatment of cirrhosis and NAFLD patients ready for further development and clinical application.

Specific deliverables

Further develop and manufacture Yaq-001 to the quality required by the MDD, to be used in the clinical trials.
Achieve regulatory and ethical approval to test Yaq-001 in clinical trials.
Undertake 3 multicentre clinical trials to establish the safety and efficacy in patients with liver disease:
- Safety, tolerability and dose finding study of Yaq-001 in patients with cirrhosis [CARBALIVE-SAFETY]
- Randomised controlled clinical trial to determine the safety and efficacy of Yaq-001 in patients with decompensated cirrhosis. [PREVENT-ACLF]
- Randomised controlled clinical trial to determine the safety and efficacy of Yaq-001 in patients with Non alcoholic fatty liver disease. [TREAT-NAFLD]
Disseminate widely the results of these trials and the therapeutic potential of Yaq-001.
Exploit the results of the CARBALIVE to raise commercial interest in the continued development of Yaq-001.

Specific deliverables

Further develop and manufacture Yaq-001 to the quality required by the MDD, to be used in the clinical trials.

Achieve regulatory and ethical approval to test Yaq-001 in clinical trials.

Undertake 3 multicentre clinical trials to establish the safety and efficacy in patients with liver disease:

Safety, tolerability and dose finding study of Yaq-001 in patients with cirrhosis [CARBALIVE-SAFETY]

Randomised controlled clinical trial to determine the safety and efficacy of Yaq-001 in patients with decompensated cirrhosis. [PREVENT-ACLF]

Randomised controlled clinical trial to determine the safety and efficacy of Yaq-001 in patients with Non alcoholic fatty liver disease. [TREAT-NAFLD]

Disseminate widely the results of these trials and the therapeutic potential of Yaq-001.

Exploit the results of the CARBALIVE to raise commercial interest in the continued development of Yaq-001.