Genfit revs up liver failure strategy with $41M biotech buyout, bagging phase 2-ready candidate

Genfit’s pivot to acute-on-chronic liver failure (ACLF) has led it to the deal table. Having granted Ipsen global rights to its lead candidate late last year, the French biotech is using some of the proceeds to buy Versantis for 40 million Swiss francs ($41 million) upfront to bag a phase 2-ready ACLF drug candidate. 

Lille, France-based Genfit made ACLF a critical pillar of its R&D strategy after clinical data blew away its hopes of becoming a leader in nonalcoholic steatohepatitis. The push into ACLF began with an effort to reposition nitazoxanide, an antiparasitic and antiviral medication, in the indication. While that effort is ongoing, Genfit has decided to bolster its pipeline by buying in assets.

The search for additional candidates has led Genfit to Versantis, a Swiss biotech that has delivered phase 1b data on a treatment designed to reverse ACLF. Genfit is paying 40 million Swiss francs to strike the deal, with a further 65 million Swiss francs potentially following if candidates deliver positive phase 2 data and win approval.

VS-01 is the most advanced candidate covered by the deal. The asset is a liposomal-based therapy that is administered into the abdominal cavity, from where it is designed to extract ACLF metabolites from the blood. After capturing the metabolites, the liposomes are drained from the body.

Versantis generated early evidence of the safety and efficacy of the treatment last year. In the phase 1b trial, 12 subjects received single or multiple consecutive doses of VS-01. The treatment was left in the cavity for two to three hours. Versantis saw dose-dependent ammonia clearance and improvements in hepatic encephalopathy based on psychometric tests.

A 60-subject phase 2 clinical trial is set to start in the fourth quarter and deliver top-line data as early as the first half of 2024. Versantis’ development plan also features filing in the U.S. early next year to enter clinical trials. The Swiss biotech is developing an oral small molecule, VS-02, that is in preclinical development as a treatment for hepatic encephalopathy. Versantis had penciled in an application in 2023 for VS-02 to enter the clinic.

Genfit will advance VS-01 and VS-02 alongside nitazoxanide, which is the subject of an upcoming pre-IND meeting with the FDA. The biotech expects its cash reserves following the takeover to support its work for around two years, giving it a shot at delivering phase 2 data on VS-01 that could dictate the success of the Versantis takeover.