Genfit (Nasdaq and Euronext: GNFT), a Lille and Paris, France, and Cambridge, MA, USA-based late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, is to acquire Versantis, a Swiss clinical stage biotechnology company focused on addressing the medical needs in liver diseases.
The deal includes an initial consideration of CHF40m due at closing, with contingent consideration of up to CHF65m upon positive Phase 2 results for VS-01 and VS-02 and regulatory approval of VS-01. In addition, Versantis is eligible to receive 1/3 of the net proceeds resulting from the potential sale of the Pediatric Review Voucher of VS-01’s pediatric application by Genfit to a third party, or 1/3 of the fair market value of this Voucher if Genfit opts to apply it to one of its own programs. Genfit will finance the base acquisition consideration from its current cash and cash equivalents.
With this acquisition, Genfit consolidates its position in ACLF (acute-on-chronic liver failure) via the integration of a clinically advanced asset presenting a solid scientific rationale supported by encouraging Phase 1b and preclinical data. The company 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, Gentit’s know-how in ACLF will broaden, with the integration of Versantis’ team of experts, joining forces to accelerate both research and development.
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 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 US Food and Drug Administration (FDA) granted VS-01 with the Orphan Drug Designation (ODD) in ACLF and in UCD and with the Rare Pediatric Diseases Designation (RPDD) for the acute treatment of UCD. The European Medicines Agency (EMA) 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.
Genfit will also be able to develop TS-01, a point-of-care diagnostic device in prototype development for the at-home measurement of ammonia in the blood, the primary cause of HE.
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.
FinSMEs
19/09/2022