Genfit has put the brakes on a late-stage trial of its experimental nonalcoholic steatohepatitis (NASH) drug elafibranor after reporting disappointing results in an interim analysis.
The phase 3 RESOLVE-IT trial was evaluating the drug in adults with NASH and fibrosis, but was unable to meet the primary endpoint of disease resolution without worsening of fibrosis in 1,070 patients tested.
NASH is characterised by a build-up of fat and scarring in the liver, and is highly contested research area at the moment, with a host of drug developers looking to find the first effective treatment for the disease.
So far, the success of those efforts has been mixed, with Genfit’s rival Gilead also reporting disappointing late-stage trials of its ASK1 inhibitor selonsertib. Another potential competitor – Intercept Pharmaceuticals – is still awaiting an FDA review of its obeticholic acid drug Ocaliva in NASH after a number of delays, first in January and then again in May, with the latter due to the ongoing COVID-19 pandemic.
Following the less-than-ideal results, Genfit said it is liaising with the trial investigators to quickly end the trial, adding that it will meet with regulatory agencies to share key findings and upcoming results from second readings of liver biopsies, which will hopefully shed more light on why the drug failed to improve patient outcomes.
Meanwhile, the company has refocused its efforts on developing its two other major programmes, including the development of elafibranor in primary biliary cholangitis (PBC) and the commercial growth of its blood-based NASH diagnostic test NIS4.
The early termination of the RESOLVE-IT trial also supports Genfit’s overall cost-saving efforts, with the cash from the early finish allowing funds to go towards more promising growth drivers for the company.
“We believe the early termination of RESOLVE-IT is the appropriate decision from an ethical and clinical perspective, and this decision will contribute to accelerating cost savings and to focusing our efforts on our two top priorities: the PBC program and NIS4,” said Pascal Prigent, CEO of Genfit.
“We are currently evaluating potential strategic partnerships that could maximise these opportunities and we will present our latest developments and complete corporate strategy at the end of September,” he added.