Genfit accelerates phase 2 liver failure trial enrollment

Genfit faces slowing patient enrollment in a significant clinical trial and has modified the study protocol to meet its goals. The biotechnology company acquired the drug VS-01, the subject of the study, from its 2022 purchase of Versantis for 40 million Swiss francs ($47 million). In 2023, Genfit commenced the enrollment of 60 patients in the initial targeted study of the liposomal-based treatment. However, recruitment has lagged behind expectations, prompting Genfit to revise the study protocol.

The company stated that the revised protocol takes into account the logistics of patient care and the multiple comorbidities of individuals with acute on-chronic liver failure (ACLF). Genfit expressed confidence that these changes would address initial obstacles and allow the company to stick to its timeline, aiming to have preliminary results by the end of the year. Achieving this timeline is crucial as it ensures that Genfit will have data before its cash reserves run out, which is projected to last until at least the start of the fourth quarter of the following year. ODDO BHF analysts noted that while specific details of the changes are unclear, the objective is to expedite patient recruitment.

The modifications include altering the inclusion and exclusion criteria for the study registered on ClinicalTrials.gov in July. Initially, patients could only participate within 96 hours of ACLF onset, but this has been extended to 168 hours. Additionally, the previous criterion requiring a certain body mass index has been replaced by a more flexible range of acceptable weights. Genfit also removed some exclusion criteria, which had previously disqualified patients without underlying cirrhosis and those with certain forms of tuberculosis. These changes to time-based restrictions and other criteria aim to widen the pool of eligible patients.

Further, in August, Genfit updated the ClinicalTrials.gov listing again, adding an additional trial site—Cedars Sinai Medical Center in Los Angeles, making it one of five centers in the U.S. The first U.S. site was added in February, and the remaining sites are located within the European Union.