Rare Daily Staff

French biotech Genfit has entered into an exclusivity agreement with a view to acquire all the share capital and voting rights of Versantis, a private Swiss-based clinical stage biotechnology company focused on addressing the growing unmet medical needs in liver diseases.

The deal includes an initial upfront payment of $41.4 million (CHF40 million), up to $67.3 million (CHF65 million) of potential additional payments contingent upon positive phase 2 results for Versantis’ lead candidates VS-01 and VS-02 and regulatory approval of VS-01, and one-third of the net proceeds from the potential sale of a Priority Review Voucher, if awarded by the U.S. Food and Drug Administration upon marketing approval of VS-01.

Genfit says the acquisition of Versantis fits perfectly within the company’s strategic vision of becoming a global leader in ACLF (acute-on-chronic liver failure) and consolidates its position in ACLF via the integration of a clinically advanced asset presenting a solid scientific rationale supported by encouraging phase 1b and preclinical data. Genfit will also further expand its pipeline in other liver diseases characterized by high unmet medical needs with additional product candidates developed by Versantis. In addition, Genfit’s know-how in ACLF will broaden, with the integration of Versantis’ team of experts, joining forces to accelerate both research and development.

ACLF is an underserved medical condition associated with short-term mortality (23 percent to 74 percent mortality at 28 days, depending on severity grade) and a significant cost of care. No drugs have been approved in this indication so far and incidence is growing at epidemic rates due to an aging population and a higher prevalence of diabetes, obesity, NASH, as well as alcohol and drug-induced liver injury. From a patient perspective, the ACLF syndrome is characterized by an abrupt life-threatening worsening of a pre-existing advanced chronic liver disease resulting in liver and extrahepatic organ failure (brain, kidneys, cardiovascular and respiratory). The cascade of multiple organ failures, including the development of a neuropsychiatric condition called hepatic encephalopathy (HE), together, lead to major complications in patients with ACLF, who can rapidly progress into coma and death. Every year, an estimated 137,000 patients are hospitalized in the United States with ACLF with very few therapeutic options.

Versantis’ main asset, VS-01, is a first-in-class innovative liposomal-based therapeutic product candidate currently in clinical development as a potential first-line therapy for the timely recovery of ACLF and urea cycle disorders (UCD). If approved, it would 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. VS-01 operates to clear toxic metabolites from the body following paracentesis, 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. A planned 60-patient randomized and controlled phase 2 proof-of-concept trial of VS-01 in ACLF is expected to launch in the fourth quarter 2022. Efficacy and safety interim data are expected as early as the first half of 2024. The FDA granted VS-01 with the Orphan Drug designation in ACLF and in UCD and with the Rare Pediatric Diseases designation for the acute treatment of UCD. The European Medicines Agency also granted VS-01 with ODD in acute liver failure.

VS-02 is a pre-clinical oral, small molecule drug candidate being developed for the chronic management of HE, considered an endemic disease worldwide. HE is a nervous system disorder brought on by advanced chronic liver disease. VS-02 will be developed as a unique colon-active formulation designed to minimize systemic absorption of ammonia and act where ammonia is primarily produced, while reducing glutamine levels in the brain.

The deal should be completed during the fourth quarter 2022, following completion of the consultation of Genfit ‘s employees representative bodies.

In parallel, Genfit continues the development of its other program evaluating NTZ in ACLF, with a pre-IND meeting scheduled with the FDA in the coming weeks, following encouraging phase 1 data.

“Versantis has an exciting portfolio that is complementary to Genfit’s,” said Pascal Prigent, CEO of Genfit. “We believe that significant synergies exist and that this acquisition will accelerate the development of several promising drug candidates in areas of high unmet needs.”

Photo: Pascal Prigent, CEO of Genfit

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