Versantis first drug enters clinical trials

In 2015, Versantis was established as a spin-off of ETH Zurich with the goal of reinventing the diagnosis, prevention, and treatment of patients with liver diseases. The company’s lead candidate, VS-01 has the potential to target the liver deficiencies associated with the higher unmet need and cost of care, such as acute hepatic encephalopathy (acute HE), acute-on-chronic liver failure (ACLF), or urea cycle disorders (UCDs). The versatile mechanism of action of VS-01 can simultaneously support multiple affected organ functions (liver, kidneys, brain), encourage liver regeneration, and save patients’ lives.

Last week, Versantis initiated its first clinical study at the Goethe University Hospital Frankfurt am Main. VS-01, is being investigated in this Phase 1b clinical trial for the acute treatment of decompensated cirrhosis. The site was trained on the protocol and is now actively screening to enroll patients. Following recent approvals by both the German regulatory authorities (BfArM) and by the hospital’s independent Ethics Committee, Versantis, has initiated a Phase 1b study with VS-01. This open-label phase 1b, multi-cohort, single ascending dose and multiple-dose study is being conducted at Goethe University Hospital with the primary objective to characterize the safety, tolerability, and pharmacokinetics of VS-01 in patients with decompensated liver cirrhosis and covert hepatic encephalopathy.

The company expects to complete the Phase 1b study and advance VS-01 to the subsequent Phase 2 trials by spring 2020. According to the company, this clinical initiation marks a new era for the entire team.

(Press release/RAN)