Swiss pharmaceutical company Versantis has reported positive data from the first-in-human trial of VS-01 in decompensated liver cirrhosis.
The Phase IB clinical trial tested the safety and tolerability of i.p.-administered VS-01 on top of standard of care in cirrhotic patients with ascites and mild hepatic encephalopathy following single and multiple intraperitoneal administrations.
Overall, the study included 12 patients, of which nine were treated with single ascending dose part (three doses) and three subjects in the multiple dose (daily treatment for four days) part of the study.
The results of the study show that VS-01, a liposomal-based intra-peritoneal fluid, was safe and well tolerated. The study reported no adverse events.
The patients who were administered with multiple doses of VS-01 showed improvements in selected biomarkers and clinical cognitive tests, indicating clinical potentiality of VS-01.
VS-01 therapy aims to reverse Acute-on-Chronic Liver Failure (ACLF) by enhancing the clearance of ammonia and other toxic metabolites from the body.
A Phase IIA study is planned to assess its efficacy against ACLF.
Goethe University Hospital Frankfurt’s Dr Jonel Trebicka, who led the research, said: “The data show that VS-01 is safe and well tolerated in cirrhotic patients with ascites and covert (mild) hepatic encephalopathy, so very promising.
“We were able to administer VS-01 using standard hospital equipment via the therapeutic paracentesis catheter, which we believe can easily be incorporated into standard of care for patients.
“There are very few treatments available for these patients and VS-01 is complementary to those, so we are excited to continue the trial and hopefully generate the data supporting this ground-breaking clinical approach.”