After selling failed NASH drug to Ipsen, French startup nabs a liver disease player in small buyout

19 Sep 2022
endpts.com
Small molecular drugPriority ReviewAcquisition
About two years after Genfit recorded a company-altering flop in NASH, the French biotech’s new vision appears to be coming into sharper focus.
In a small-time buyout, Genfit acquired the Swiss startup Versantis for CHF40 million upfront, or roughly $41.4 million, the companies announced early Monday morning. The deal, which includes another CHF65 million ($67.3 million) in milestones, helps position Genfit better in a separate but related rare liver disease: acute-on-chronic liver failure, or ACLF.
Additionally, should Versantis’ lead program be awarded a priority review voucher from the FDA, Genfit would be entitled to one third of the funds from its sale — or a third of a market value equivalent if Versantis applies it to its own pipeline.
Though Genfit CEO Pascal Prigent alluded to “significant synergies” in an early morning press release, a company spokesperson told Endpoints News in an email that there are no layoffs planned post-merger.
Monday’s deal comes as Genfit fully moves past its NASH failure. Late last year, the biotech shipped off the snakebit drug to Ipsen, which fronted about $136 million and promised more than $575 million in potential milestones. The drug, elafibranor, had failed a highly anticipated Phase III NASH trial back in May 2020.
Ipsen fronts $136M to bag Genfit's once-failed NASH drug, betting on its potential in rare liver condition
Following that, the biotech slashed its workforce by about 40% and promised to try testing elafibranor in primary biliary cholangitis, an autoimmune disease affecting the bile ducts, as well as commercializing a diagnostic tool for NASH. The Ipsen deal rendered the former moot, however.
Meanwhile, Versantis’ lead candidate, VS-01, is central to Monday’s acquisition. A Phase II study is expected to launch in the fourth quarter, with Versantis describing it as a “proof-of-concept” and intending to enroll 60 patients. The first efficacy and safety data are expected as early as 2024’s first half, Versantis said.
Due to the FDA’s bestowal of a rare pediatric disease designation upon it, the program could win Versantis a PRV if it’s approved.
After selling failed NASH drug to Ipsen, French startup nabs a liver disease player in small buyout
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Source: Endpts
The program itself is designed to help patients whose only current recourse is a liver transplant. Versantis’ platform works not by delivering drugs, but by draining toxins using liposomes — an “undelivery system,” former CEO and current CSO Vincent Forster once told Endpoints. A solution containing “microscavengers” is injected into a patient’s abdomen, soaks up ammonia and other toxins and is then drained.
Swiss biotech raises $16M to test 'undelivery mechanism' for rare liver disease
Versantis’ follow-up program, VS-02, is an oral small molecule designed to work similarly by minimizing ammonia absorption in patients with hepatic encephalopathy (HE). Genfit also gets its hands on TS-01, a diagnostic device that aims to measure ammonia levels in HE patients.
The deal is expected to close in the fourth quarter.
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