Genfit (Nasdaq and Euronext: Genfit) A Lille, as well as Paris, France, and Cambridge, MA, USA-based biopharmaceutical company in its late stage that is committed to improving people’s lives suffering from chronic liver disease. The company is planning to acquire Versantis; a Swiss-based clinical-stage biotechnology firm focused on addressing the medical requirements of liver diseases.
The agreement comprises an initial amount of CHF40m due at the close and the possibility of contingent consideration of up to CHF65m after successful Phase 2 findings for both VS-01 as well as the VS-02 as well as regulatory approval for the VS-01. Additionally, Versantis is eligible to get 1/3 of net profits resulting from the possible purchase of the pediatric review voucher in the VS-01’s pediatric program through Genfit to a third party and 1/3 of the market price of the Voucher if Genfit decides to use this Voucher to any of their programs. Genfit will pay the initial purchase cost using its funds in cash or cash equivalents.
Through this acquisition, Genfit strengthens its leadership position within ACLF (acute-on-chronic liver dysfunction) by integrating an innovative clinical asset with an established scientific basis supported by positive preliminary data from Phase 1b. Genfit will also develop its pipeline for other liver diseases with significant unmet medical requirements with the addition of additional product candidates created by Versantis. Additionally, Gentit’s expertise in ACLF will expand thanks to the incorporation of the Versantis group of experts. The two teams will work together to accelerate the development and research.
Versant is a principal asset; VS-01 is the first-in-class, innovative therapeutic drug candidate based on liposomal currently under development for clinical trials as a possible first-line treatment to help speed up the recovery process of ACLF as well as UCD. If approved, it’ll be the first medicine that utilizes the intraperitoneal route to aid kidneys, the liver and the brain, the organs most commonly affected in patients with the cirrhotic disease.
VS-01 removes toxic metabolites from the body after paracentesis by removing them from the bloodstream into the peritoneal (abdominal) cavity, where they are sucked up by the scavenging liposomes that are made by the company, which are then removed from the body. A 60-patient, randomized, and controlled Phase 2 proof-of-concept study for VS-01 within ACLF is scheduled to begin within the last quarter of 2022.
The safety and efficacy interim data could be available as early as the first or second quarter of 2024. It is expected to be available in the first half of 2024. US Food and Drug Administration (FDA) granted VS-01 in conjunction with an Orphan drug designation (ODD) for ACLF as well as in UCD and also with a Rare Pediatric Diseases Designation (RPDD) to treat acute cases of UCD. In addition, the European Medicines Agency (EMA) also granted VS-01, which has ODD for acute liver failure.
The VS-02 drug is a preclinical small molecule oral drug candidate developed to manage the chronic effects of HE, known as a widespread disease. The nervous system is affected by HE, a condition caused by advanced chronic liver diseases. VS-02 is planned to be an exclusive colon-active formula created to limit systemic ammonia absorption, work in the areas where ammonia is produced most, and reduce neuronal glutamine concentrations.
Genfit can also create the TS-01, a point-of-care diagnostic device in the prototype stage for home-based measurement of ammonia levels in the blood, which is the main reason for HE.
Parallel to this, GENFIT continues the development of its other program to study NTZ in ACLF in ACLF, with an initial meeting with the FDA within the coming weeks, following the positive results from the Phase 1 study.