GENFIT Shifts Focus: Discontinuation of VS-01 in ACLF

GENFIT’s Strategic Shift in Focus

GENFIT, a leading biopharmaceutical company in the realm of liver disease treatment, has announced a significant pivot in its clinical development strategy. This change comes as the company decides to discontinue its VS-01 program in the treatment of Acute-on-Chronic Liver Failure (ACLF) and instead concentrate its efforts on Urea Cycle Disorder (UCD).

Key Developments in the Clinical Trials

The decision was influenced by the emergence of a Serious Adverse Event (SAE) during the UNVEIL-IT® clinical trial of VS-01, where a case of peritonitis was reported among participants. Following a thorough review from the independent Data Monitoring Committee (iDMC), it was determined that while the study could technically continue, it necessitated increased data and monitoring. However, after weighing the safety concerns against the benefit-to-risk ratio for patients with ACLF, GENFIT opted to cease both the UNVEIL-IT® trial and the exploratory study examining VS-01’s effectiveness in patients suffering from Hepatic Encephalopathy (HE).

Gratitude to Participants

In light of this decision, GENFIT expressed its profound gratitude to all the patients, families, and dedicated investigators who participated in the trials, recognizing their essential contributions to the research process.

Focus on Urea Cycle Disorder

Despite stepping back from the ACLF indication, GENFIT remains committed to advancing the preclinical evaluation of VS-01 for Urea Cycle Disorder. This particular condition is critically important, with many patients experiencing life-threatening hyperammonemic crises. GENFIT believes that VS-01 has the potential to address the unmet medical needs of children afflicted with this disorder, providing a new glimmer of hope through promising ammonia clearance data.

Continued Commitment to ACLF

While GENFIT pivots towards UCD, its dedication to tackling ACLF and closely related conditions remains unwavering. Given the significant medical need and lack of approved therapies in this area, the company is intensifying its efforts with other assets in its pipeline. These assets are designed to target various aspects of ACLF and explore diverse therapeutic mechanisms.

Innovative Research Directions

The clinical landscape for ACLF treatment is evolving, and GENFIT is aiming to accelerate the development of four distinct candidates, which are designed with various mechanisms of action and routes of administration. The company anticipates delivering data on safety and early efficacy from its G1090N program by the year's end, fostering optimism for unveiling effective therapies.

Cholangiocarcinoma Trials

Additionally, GENFIT is on track to unveil Phase 1b results for GNS561 in the treatment of cholangiocarcinoma, a rare cancer type associated with significant mortality rates. The novel GNS561 is being assessed alongside a MEK inhibitor for patients with KRAS mutations, reinforcing GENFIT’s commitment to advancing treatment options for serious conditions.

Financial Outlook Post-Discontinuation

The recent discontinuation of the VS-01 program is expected to markedly reduce GENFIT’s operational expenses. This strategic decision affords the company enhanced flexibility to extend its financial runway significantly, potentially beyond 2028. The resources freed from this program could also serve as a foundation for exploring innovative business development initiatives directed at addressing the urgent needs within ACLF care.

About GENFIT

GENFIT stands as a pioneering force in liver disease research and development. Committed to addressing rare and life-threatening liver conditions, the company boasts over 20 years of scientific expertise. With several programs in its R&D pipeline, GENFIT targets a spectrum of illnesses, including ACLF and cholangiocarcinoma.

Genetic Conditions and Treatments

Targeting ailments like UCD and organic acidemia, GENFIT’s dedication shines through in its ongoing development of high-impact therapeutics. Their innovative approach from early development stages to advanced commercialization has been showcased through the successful launch of Iqirvo® (elafibranor), approved across multiple regions for Primary Biliary Cholangitis.

Frequently Asked Questions

What are the main changes in GENFIT's development strategy?

GENFIT has decided to discontinue its VS-01 program for ACLF and will focus on developing VS-01 for Urea Cycle Disorder (UCD).

Why was the VS-01 ACLF program discontinued?

The discontinuation was prompted by a Serious Adverse Event during clinical trials, leading to a reevaluation of the program’s risk-benefit ratio.

What is the significance of Urea Cycle Disorder in GENFIT's strategy?

Urea Cycle Disorder represents a significant unmet medical need, particularly in children experiencing hyperammonemic crises, making it a priority for GENFIT's research efforts.

What other conditions is GENFIT targeting?

GENFIT continues to focus on ACLF, cholangiocarcinoma, and other life-threatening liver diseases with various therapeutic candidates in development.

How will this strategic shift impact GENFIT's financial position?

The reduction in operational expenses following the discontinuation of the VS-01 program is expected to extend GENFIT's financial runway and allow for new business initiatives.

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