VERSANTIS initiated its first clinical study site which will trial VS-01 in patients: Goethe University Hospital Frankfurt. This 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 now initiated a Phase 1b study with VS-01, a lifesaving multi-organ support therapy able to enhance the clearance of ammonia and other toxins from the body. This open-label phase 1b, multi-cohort, single ascending dose and multiple dose study is being conducted at Goethe University Hospital in Frankfurt am Main, Germany, with the primary objective to characterize the safety, tolerability, and pharmacokinetics of VS-01 in patients with decompensated liver cirrhosis and covert hepatic encephalopathy.
Only 4 years after incorporation, this clinical initiation marks a new era for VERSANTIS. The Company expects to complete this Phase 1b study and advance VS-01 to the subsequent Phase 2 trials by spring 2020.