VS-01 safe, well tolerated in patients with decompensated cirrhosis

Versantis announced positive results from a phase 1b clinical trial of VS-01 in patients with decompensated cirrhosis.

“We are very encouraged by the compelling results from this phase 1b trial, which prove the excellent tolerability profile of VS-01 in a cirrhotic patient population,” Vincent Foster, CEO and co-Founder of Versantis, said in the release. “We look forward to the continued development of this therapy in a phase 2a study starting early 2022 and hope to soon provide a meaningful new treatment option to patients suffering from acute liver diseases, whom today still face great unmet medical need.”

According to a press release, VS-01 was safe and well tolerated in this first-in-human, single ascending and multiple dose study. The study was led by Jonel Trebicka, MD, PhD, professor at the Goethe University Hospital Frankfurt.

Trebicka and colleagues assessed the safety and tolerability of VS-01 in cirrhotic patients with ascites and mild hepatic encephalopathy. The researchers successfully treated 12 patients; nine in single ascending dose part (three doses) and three in the multiple dose part (daily treatment for 4 days).

There were no serious adverse events reported and none of the patients discontinued due to an adverse event. Patients who received multiple doses of VS-01 demonstrated improvements in selected biomarkers and clinical cognitive tests, according to the release.

The data support the advancement into a phase 2a proof of concept study of VS-01 in patients with acute on chronic liver failure.