(BFM Stock Exchange) – Lille Biotech falls on the Paris Stock Exchange after stopping a clinical program evaluating VS -01 in acute liver insufficiency on Chronicle, due to a case of peritonitis.

Genfit prefers to stop the costs that he has inserted. The Biotechnologies Society said on Friday September 19 after the end of the Paris market, the stopping of its VS-01 program in ACLF (acute liver insufficiency on Chronicle).

Genfit made this decision following a case of peritonitis which occurred in the UNVEIL-IT study, therefore evaluating its potential treatment VS-01 in patients with ACLF Grade 1, 2 or 3A and ascites.

Biotech could however continue its program subject to additional data and surveillance. But Genfit considered that the benefit/risk profile was not acceptable in a population of very fragile patients exposed to a critical infectious risk, reports Oddo BHF.

By consistency, the company also ends its study of proof of concept in hepatic encephalopathy associated with ACLF, adds the design office.

A refocusing in the UREA Cycle Disorder

Genfit does not put the VS-01 program at Rebus. The company will redirect it in the treatment of UCD (UREA CYCLE DISORDER), a genetic disease characterized by an acute hyperammonieic crisis (HAC).

“Pathology, patients and the administration scheme of the candidate-drug will be very different from those of ACLF. There is an important medical need in this indication and, on the basis of ammonia clearance data, we believe that VS-01 has the potential to be a useful therapeutic option for children with this disease,” explains Genfit.

The so -called group also remains fully committed to the treatment of ACLF and associated pathologies such as acute liver decompensation (DA) or liver encephalopathy (EH), with four other differentiated programs.

“The first milestone is expected by the end of 2025 with early tolerance data and biomarkers for G1090N. On another strategic axis, Genfit also targets IB phase results before the end of the year for GNS561 in cholangiocarcinoma, an orphan indication in oncology”, specifies the design office.

A clinical disappointment

However, the cessation of VS-01 in the ACLF “constitutes a clinical disappointment” for Oddo BHF, “insofar as it was one of the most advanced clinical programs of the company”.

“This reduces short-term visibility in this indication of high medical need. Nevertheless, the choice is consistent: it avoids investing more in an asset which would most certainly have encountered regulatory and marketing challenges,” he continues.

However, Genfit explains that this judgment will allow him to substantially reduce his operating expenses. “This will offer us strategic flexibility, either to prolong at least one year our cash forecasts compared to previous forecasts, or beyond 2028, or to explore new mechanistic approaches through business development initiatives to fill the multiple urgent gaps in the management of the ACLF”, adds the company.

But for the time being, disappointment is palpable. On the Paris Stock Exchange, the Genfit action further fell 8.7% around 4:10 p.m. on Monday, September 22.

In its note published before the opening of the Parisian market, the design office expected a negative reaction to the market, due to the loss of an advanced clinical catalyst and the perception of a pipeline (drugs under development).

“The results of G1090N and GNS561 expected at the end of the year will therefore be important to restore credit to the second clinical history of Genfit”, estimate the analysts of Oddo BHF which maintains their recommendation to outperformance, but lower their course objective to 9 euros due to the withdrawal of VS-01 in the ACLF of their model.