Genfit Halts Liver Failure Program After Phase 2 Trial Setback

Genfit, a French pharmaceutical company, has announced the discontinuation of its VS-01 development program for acute-on-chronic liver failure (ACLF) following a serious adverse event in a phase 2 clinical trial. This decision marks a significant setback for the company's liver disease portfolio and has prompted a strategic realignment of its research priorities.

Trial Termination and Safety Concerns

The phase 2 Unveil-IT trial, which was evaluating VS-01 in ACLF patients, was stopped after a participant experienced peritonitis, an inflammation of the abdominal lining. While the independent data monitoring committee concluded that the study could continue with additional monitoring, Genfit opted to terminate the trial entirely. The company cited concerns over the target population's clinical profile and the implications of the safety signal for VS-01's benefit-risk profile in ACLF patients.

In addition to the Unveil-IT trial, Genfit has also halted a related proof-of-concept study focused on ACLF. These decisions come after the company had previously made efforts to address slow enrollment in the VS-01 trials, highlighting the challenges faced in developing treatments for this complex liver condition.

Strategic Pivot and Pipeline Reassessment

Despite the setback in ACLF, Genfit is not abandoning VS-01 entirely. The company will continue preclinical evaluations of the asset for urea cycle disorder (UCD), noting differences in patient populations and drug administration setups between UCD and ACLF. This strategic pivot allows Genfit to potentially salvage value from the VS-01 program while mitigating risks associated with its use in ACLF patients.

Genfit's ACLF pipeline remains active, with four other assets under development. These candidates, which employ different routes of administration and mechanisms of action than VS-01, are expected to be unaffected by the recent safety signal. The company's next data release is scheduled for late 2025, featuring safety results and early efficacy indicators from a study of G1090N in healthy volunteers.

Financial Implications and Future Outlook

The discontinuation of VS-01 in ACLF is expected to have significant financial implications for Genfit. The company projects that the program's termination will substantially reduce its spending, potentially extending its cash runway by at least one year beyond 2028. This financial flexibility may allow Genfit to explore new opportunities, including the possibility of acquiring additional early-stage ACLF assets.

Guggenheim analysts have noted that the freed-up capital could provide Genfit with strategic flexibility to pursue new ventures in the ACLF space. As the company regroups from this setback, industry observers will be closely watching its next moves in the competitive landscape of liver disease therapeutics.