GENFIT: Positive Phase 2 Results in Study of Elafibranor in Biliary Cholangitis

• Elafibranor successfully meets primary endpoint with high statistical significance of p<0.001
  * Substantial reductions in alkaline phosphatase in patients receiving elafibranor; 52% (80 mg) and 44% (120 mg) when compared to placebo
  * Significant response rate on composite endpoint used for regulatory approval, with 67% (80 mg) and 79% (120 mg) responders vs 6.7% for placebo (p</=0.001)
  * Potential for improved efficacy and tolerability compared to existing second-line PBC therapy, supports advancement to the next stage of development
  GENFIT(Euronext: GNFT – ISIN: FR0004163111), a biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver diseases, in particular those of metabolic origin, and hepatobiliary diseases, today announced positive results from its Phase 2 study of elafibranor in patients with primary biliary cholangitis (PBC), a chronic liver disease.
  This trial was a multicenter (US and Europe), double-blind, randomized, placebo- controlled, 12-week treatment, Phase 2 study to evaluate the efficacy and safety of elafibranor (80 mg and 120 mg once-daily) in adult patients with PBC who had an inadequate response to ursodeoxycholic acid (UDCA).
  The primary endpoint of “Change at week 12 in serum alkaline phosphatase (ALP) from baseline” was met. Both elafibranor doses demonstrated significant decrease in mean ALP:  -48% for 80 mg -41% for 120 mg with +3% increase for placebo leading to highly significant treatment effect versus placebo: -52% for 80 mg (p<0.001) and -44% for 120 mg (p<0.001).
  A key secondary endpoint was the responder rate for patients achieving the composite endpoint of serum ALP <1.67xULN, an ALP decrease >15%, and total bilirubin (TB) <ULN. On this endpoint, elafibranor achieved the substantially higher response rates of 67% for 80 mg and 79% for 120 mg  as compared to 6.7% for placebo (p=0.001 and p<0.001, respectively). ALP is an established surrogate marker of disease progression in PBC, and this composite endpoint has been previously used for regulatory approval.
  Alongside substantial reductions in ALP, in both elafibranor-treated groups, patients showed improvement in other PBC markers such as gamma-glutamyl transferase and metabolic markers such as total cholesterol, low-density lipoprotein-C, and triglycerides. Improvement in pruritus was observed and will be confirmed in a study of longer duration. Treatment with elafibranor was generally well-tolerated, with similar adverse events across the treatment and placebo groups.

https://www.marketscreener.com/GENFIT-16311755/news/GENFIT-Positive-Phase-2-Results-from-Study-of-Elafibranor-in-Primary-Biliary-Cholangitis-27712770/