Genfit SA discontinues lead programme
Lille-based Genfit SA has discontinued Phase II development of its lead drug candidate VS-02, a liposomal ammonia scavenger designed to prevent organ failure in acute chronic liver failure (ACLF). The company will reprioritize its (preclinical) pipeline, including VS-02, which will be further developed in the area of urea cycle disorder (UCD).
Lille-headquartered Genfit SA has discontinued clinical development of its liposomal ammonia scavenger VS-01, developed by Swiss Versantis AG, which Genfit acquired in 2022. Genfit discontinues development in acute-on-chronic liver failure (ACLF) and reprioritizes it on UCD (Urea Cycle Disorder).
The specialist for liver disorders said it wants to accelerate the development of its four assets – G1090N, SRT-015, CLM-022 and VS-02-HE – currently under development in ACLF, which are all based on different mechanisms of action and use different routes of administration.
VC-01 is a liposomal formulation.
In previous studies involving patients with decompensated liver cirrhosis, single and multiple intraperitoneal administrations of VS-01 led to reductions in blood metabolites associated with ammonia-triggered organ failure in ACLF. The objective was the rapid elimination of ammonia and other toxic metabolites to mitigate liver, kidney, and brain dysfunction by injecting liposomally formulated VS-01 into the peritoneal cavity.
Genfit SA‘s decision to terminate VC-01 development in ACLF follows the occurrence of a peritonitis case reported as a Serious Adverse Event (SAE) in the open-label Phase II study UNVEIL-IT evaluating VS-01 in patients with ACLF grades 1, 2, or 3a and ascites, and subsequent review and feedback from the independent Data Monitoring Committee (iDMC). The committee concluded that the trial could continue but required additional data and monitoring. Despite the possibility to move ahead with the study, GENFIT decided – after considering the target population’s clinical profile as well as the implications of this type of safety signal for the benefit/risk ratio of VS-01 in this indication – to discontinue both UNVEIL-IT and the proof-of-concept study evaluating VS-01 in patients with Hepatic Encephalopathy (HE) grades 2 to 4 in the presence of Acute Decompensation (AD) or ACLF grade 1 and ascites.
Discontinuation of Genfit’s lead programme will require significant restructuring to substantially reduce operating expenses.
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