Disclosures: Schettenberg reports consulting for Boehringer Ingelheim, Bristol Myers Squibb, Echosens, Galmed, Genfit, Gilead Sciences, Intercept Pharmaceuticals, Madrigal, Nordic Bioscience, Novartis, Pfizer, Roche, Sanofi and Zydus, and receiving research funding from Gilead. Kowdley reports serving as consultant to or on advisory boards for Conatus, CymaBay, Gilead, Intercept, La Jolla, Merck and Novartis. He also reports receiving research support from Genfit, Gilead, High Tide, Intercept, NGM Biopharma and Novartis and serving as a speaker for AbbVie, Gilead Sciences and Intercept.
February 11, 2021
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Elafibranor safe, effective in patients with PBC

Disclosures: Schettenberg reports consulting for Boehringer Ingelheim, Bristol Myers Squibb, Echosens, Galmed, Genfit, Gilead Sciences, Intercept Pharmaceuticals, Madrigal, Nordic Bioscience, Novartis, Pfizer, Roche, Sanofi and Zydus, and receiving research funding from Gilead. Kowdley reports serving as consultant to or on advisory boards for Conatus, CymaBay, Gilead, Intercept, La Jolla, Merck and Novartis. He also reports receiving research support from Genfit, Gilead, High Tide, Intercept, NGM Biopharma and Novartis and serving as a speaker for AbbVie, Gilead Sciences and Intercept.
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Patients with primary biliary cholangitis treated with elafibranor experienced lowered alkaline phosphatase after 12 weeks, according to study results.

“These promising findings along with existing safety data derived from past clinical trials suggest elafibranor is a promising development candidate as a potential novel treatment for patients with PBC,” Jörn M. Schattenberg, MD, from University Medical Centre Mainz in Germany, said in a press release. “Regulatory authorities know the disease well and there remains an important unmet need to be addressed as many patients at present remain without a long-term therapeutic option.”

Researchers conducted a double-blind trial comprising 45 patients with PBC who had incomplete response to ursodeoxycholic acid. They randomly assigned patients to receive 80 mg or 120 mg of elafibranor (Genfit) or placebo. The primary outcome of the study was the relative change of alkaline phosphatase at 12 weeks.

In the placebo group, patients achieved a relative change in alkaline phosphatase of +3.2±14.8%. Patients in the 80 mg (–48.3±14.8%) and 120 mg (–40.6±17.4%) elfribanor groups achieved greater changes in ALP (both P < .001 vs. placebo).

In the 80 mg group, 67% of patients achieved a composite endpoint of alkaline phosphatase at least 1.67-fold less than the upper limit of normal, a decrease of alkaline phosphatase greater than 15% and total bilirubin below the upper limit of normal. In the 120 mg, 79% achieved these endpoints compared with just 6.7% of patients in the placebo group.

Patients treated with elafibranor also experienced decreased levels of gamma glutamyl transferase, Igm, 5’ -nucleotidase and hsCRP.

In their safety analysis, researchers found that all non-serious adverse events that were potentially drug related were either mild or moderate.

“These encouraging phase 2 data are particularly exciting as they highlight a favorable trend in pruritus, which is a debilitating symptom of PBC and one that significantly affects patients’ quality of life,” Kris V. Kowdley, MD, from the Liver Institute Northwest in Seattle, said in the release. “These data suggest that elafibranor is a promising drug candidate, and I’m eager to see whether this trend becomes more significant following longer-term administration, while maintaining the favorable safety/tolerability profile we have seen in the phase 2 trial.”