A company that had been potentially second in line to receive Food and Drug Administration approval for a drug to treat nonalcoholic steatohepatitis is now moving away from developing NASH drugs after the failure of a Phase III clinical trial.
Lille, France-based Genfit said Wednesday it had formally terminated the Phase III RESOLVE-IT trial of elafibranor in patients with NASH and fibrosis. Instead, it will prioritize the drug’s development in primary biliary cholangitis, or PBC, while also developing a noninvasive diagnostic for detecting at-risk NASH, the NIS4.
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Shares of Genfit rose 2.3% on the Nasdaq when markets opened Thursday and were still up by 1.7% in the afternoon.
“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, the technology to support a noninvasive diagnostic program in NASH,” Genfit CEO Pascal Prigent said in a statement. “We are currently evaluating potential strategic partnerships that could maximize these opportunities, and we will present our latest developments and complete corporate strategy at the end of September.”
The company noted that second-line treatment of PBC, a disease in which the bile ducts of the liver are slowly destroyed, represents a market opportunity that is expected to reach $1.5 billion by 2035. Elafibranor has demonstrated what the company called promising results in Phase II development, and it is now planning to start a Phase III trial.
Following a review of interim efficacy data, Genfit said in May that RESOLVE-IT had not met its primary surrogate efficacy endpoint of NASH resolution without worsening of fibrosis.
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The study’s failure leaves only one drug with the chance to reach the market in the near term, Intercept Pharmaceuticals’ obeticholic acid, or OCA. Even still, Intercept hit a speed bump at the end of last month when the FDA turned down its regulatory approval application with a complete response letter – essentially a notice of rejection – that requested additional safety and efficacy data from its Phase III clinical trial.
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