Elafibranor met its phase 2 primary endpoint of reducing alkaline phosphatase after 12 weeks of treatment in patients with primary biliary cholangitis, according to a press release from Genfit.
Elafibranor is an agonist of the peroxisome proliferator-activated receptor-alpha and peroxisome proliferator-activated receptor-delta that has previously been shown to improve insulin sensitivity, glucose homeostasis and lipid metabolism, and reduce in inflammation.
Results from the randomized control study showed a significant decrease in alkaline phosphatase of –48% in patients treated with 80 mg and –41% in those who received 120 mg daily for 12 weeks compared with a 3% increase among controls who received placebo (P < .001).
Additionally, patients treated with elafibranor showed improvements in gamma-glutamyl transferase levels, total cholesterol, LDL, triglycerides, and pruritus.
Elafibranor was well-tolerated with similar adverse events compared with placebo.
“We believe the strength of evidence on the surrogate endpoint for registration as well as the potential benefits on itching qualify the program to rapidly advance into phase 3 in PBC,” Jean-François Mouney, chairman and CEO of Genfit, said in the release. “This trial strongly supports elafibranor, our dual [peroxisome proliferator-activated receptor] alpha and delta agonist in PBC, to treat a vast majority of target patients while potentially improving their quality of life.”