Slow enrollment in a key clinical trial has driven Genfit to rework the protocol to try to keep the study on track. The biotech said the changes reflect the comorbidities of people with acute on-chronic liver failure (ACLF) and the logistics of caring for the patients.
Genfit acquired the drug being studied, VS-01, when it paid 40 million Swiss francs ($47 million) to buy Versantis in 2022. The following year, the biotech began enrolling 60 patients for the first targeted study of the liposomal-based candidate.
However, the initial uptake of recruitment was below expectations, Genfit said, leading the biotech to make changes intended to kickstart enrollment.
“We have modified our protocol to better account for the logistics of the care for these patients, as well as their many comorbidities,” Genfit said in a statement Thursday. “We feel that the latest version of the protocol addresses the initial challenges and should allow us to maintain our timeline of having preliminary results before the end of the year.”
Hitting the timeline would ensure Genfit has data well in advance of the end of its cash runway, which is scheduled to extend to at least the start of the fourth quarter of next year. In a note to clients, ODDO BHF analysts said they “do not know the details (patient selection criteria depending on their comorbidities) of this change but the aim is clear: speed up patient recruitment in this study.”
Genfit changed the inclusion/exclusion criteria for the study on ClinicalTrials.gov in July, including by allowing patients to participate up to 168 hours after the onset of ACLF. The older criteria set the limit at 96 hours. At the time, Genfit dropped a requirement for patients to be below a certain body mass index and replaced it with a need for them to fall within a range of acceptable weights.
The biotech also removed some exclusion criteria, eliminating barriers that previously prevented people without underlying cirrhosis and with certain forms of tuberculosis from enrolling. As with the inclusion criteria, Genfit made changes to time-based restrictions that could increase the pool of eligible patients.
Genfit updated the ClinicalTrials.gov listing again in August, although that revision only added one trial site, the Cedars Sinai Medical Center in Los Angeles, to the list of centers enrolling patients in the study. The site is one of five centers in the U.S. Genfit added the first U.S. site in February. The remaining sites are in the European Union.