Genfit has a drug candidate on its way to clinical testing for a rapidly progressive and potentially fatal complication of chronic liver disease. from acquisition of Versantisit adds another drug that works differently and is in development for the same disease.
Lille, France-based Genfit announced Monday that it has agreed to pay 40 million Swiss francs (about $41.4 million) to buy Versantis, a privately held Swiss biotech company focused on developing drugs for liver disease. In addition to the upfront payment, Versantis shareholders could earn up to 65 million Swiss francs (about $67.3 million) related to the progress of clinical trials and regulatory approval of the lead asset.
Zurich, Switzerland-based Versanis’ primary disease target is acute chronic liver failure (ACLF), a syndrome that can develop in patients whose chronic liver disease has progressed to cirrhosis. In addition to liver failure, this condition can lead to failure of other organs such as the brain, kidneys, heart and lungs. ACLF can rapidly progress to coma and then death. According to Genfit, approximately 137,000 patients are hospitalized with ACLF in the US each year. The condition has no FDA-approved therapies.
Versantis’ most advanced program, VS-01, uses liposomes, which are small, spherical vesicles that can be used as delivery vehicles. The company says its drug clears toxic metabolites from the body by extracting them from the blood and taking them to the abdominal cavity, where they are taken up by liposomes, which are then drained from the body. In a phase 1b study, Versantis reported that its drug was safe and well tolerated by the 12 study participants who did not experience dose-limiting toxicities. A phase 2 trial of 60 patients is due to begin in the fourth quarter of this year. In addition to ACLF, the drug has potential application as a treatment for urea cycle disorder. The FDA has given the drug a rare pediatric disease designation in this indication. In Europe, the drug candidate Versantis has an orphan drug designation.
Genfit’s approach to developing an ACLF therapy involves repurposing nitazoxanide, or NTZ for short. This older drug is used to treat diarrhea and intestinal inflammation caused by parasites. Genfit is looking to apply the drug to liver and fibrotic diseases. The company said a meeting with the FDA is planned to discuss clinical trial plans for NTZ in ACLF following encouraging Phase 1 data that inform potential dose adjustments in patients with cirrhosis and liver impairment.
The acquisition of Versantis is in line with the focus on liver disease that Genfit said it will maintain after the high-profile Phase 3 in 2020. a failure of elafibranor, a drug the biotech was developing for the fatty liver disease nonalcoholic steatohepatitis (NASH). The company abandons NASH drug pursuit but restructures and focuses small molecule development in primary biliary cholangitis, a different rare liver disease. At the end of last year, Genfit licensed the global rights of elafibranor to Ipsen for €120 million upfront. Under the license agreement, Genfit is still responsible for the Phase 3 development of elafibranor until the completion of the double-blind treatment period of this study.
Speaking on a conference call on Monday, Genfit CEO Pascal Prigent said the acquisition of Versantis was a logical extension of the corporate strategy for rare liver diseases that the company launched in late 2020. The Ipsen deal provided Genfit with cash in number to fund acquisitions, with an eye on assets that are in the clinic or close to clinical development. The acquisition of Versantis brings Genfit programs for other liver diseases. VS-02 is in preclinical development for the treatment of chronic hepatic encephalopathy, a disorder of the nervous system caused by advanced chronic liver disease. Versantis is also developing TS-01, a point-of-care diagnostic in development for the home measurement of blood ammonia, the primary cause of hepatic encephalopathy.
“We believe that Versanis’ portfolio of programs gives us exactly what we are looking for,” Prigent said. “Following the acquisition, Genfit will have multiple promising programs in rare liver diseases and will be a global leader in ACLF, a therapeutic area that we believe is important and underserved.”
The acquisition agreement could bring in more money than the sale of an FDA priority review voucher. Under this FDA program, regulatory approval of an orphan drug may result in the award of a voucher that provides fast-track review of another rare disease drug. This program aims to stimulate drug development for rare diseases, and the rare pediatric disease designation given to VS-01 in urea cycle disorder makes it eligible for a voucher if the drug is approved.
A company that receives a voucher can apply it to any of its own drugs, but many companies choose to sell these vouchers, reaching prices of $100 million or more. Under the acquisition agreement, Versantis is entitled to receive one-third of the net proceeds from the voucher sale. If Genfit decides to use the voucher for one of its own programs, Versantis will be entitled to one-third of the fair market value of the voucher.
Genfit expects to close the acquisition of Versantis in the fourth quarter of this year.
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