Pipeline

Promising drug candidates for treatment of Liver Disease

Versantis’ pipeline starts with strong science and aims to improve patients’ outcome and potentially relieve health care systems from the economic burden of liver diseases. 

Our lead program, VS-01-ACLF, is Phase 2a-ready following clinical trial application approval from The Federal Institute for Drugs and Medical Devices (BfArM) in Germany. This product candidate leverages our proprietary scavenging liposomes technology to potentially reverse the multi-organ complications arising from acute-on-chronic liver failure in patients with advanced liver cirrhosis. It is being developed for two acute indications, both of which are rare diseases associated with high unmet medical needs. 

Versantis’ discovery programs aim to widen the company’s footprint in liver diseases and provide a continuum of care from that targeted point-of-care, diagnostic test kit of ammonia levels in blood (TS-01) to the potential treatment of hepatic encephalopathy (VS-02).

VS-01-ACLF

VS-01-ACLF is an innovative liposomal-based therapeutic product candidate in clinical development as a potential first-line therapy for the timely recovery of acute-on-chronic liver failure (ACLF). If approved, it will be the first drug to use the intraperitoneal route to simultaneously support the liver, kidney and brain, the organs that most often fail in cirrhotic patients.

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VS-01-ACLF clears ACLF metabolites from the body by extracting them from the blood into the peritoneal (abdominal) cavity, where they are captured by proprietary scavenging liposomes which are then drained from the body. Versantis’ liposome technology provides a potentially safe and timely recovery of multi-organ complications arising from liver cirrhosis.

VS-01-ACLF was shown to be safe and well tolerated in in a Phase 1b study of 12 patients in cirrhotic patients with ascites (single ascending and multiple doses), with no dose-limiting toxicities or unexpected safety signals. Patients receiving multiple doses of VS-01-ACLF showed activity in selected biomarkers and clinical cognitive tests, which supports the drug’s clinical potential in the target indication of ACLF.

VS-01 received the following regulatory incentives, to enable its clinical development and potentially deliver hope to patients and their families: 

US Food and Drug Administration (FDA)

  • VS-01-UCD has received Rare Pediatric Diseases Designation (RPDD) for the acute treatment of UCD
  • VS-01-ACLF has received Orphan Drug Designation (ODD) in ACLF 

European Medicines Agency (EMA) 

  • Orphan Drug Designation (ODD) in acute liver failure 

VS-01's intellectual property is protected by two patent families approved internationally.

VS-02

VS-02 is an oral, small molecule drug candidate being developed for the chronic management of hepatic encephalopathy (HE), considered an endemic disease worldwide. VS-02 will be developed as a unique colon-active formulation designed to minimize systemic absorption and act where ammonia is primarily produced, while reducing glutamine levels in the brain.

TS-01

TS-01 a unique point-of-care diagnostic device in prototype development for the at-home measurement of ammonia in blood, the primary cause of HE. It has the potential to provide HE patients with an instrument to manage tighter control of their blood-ammonia levels and provide a means to better manage companion therapeutic treatments for their condition.

Scientific Publications