Ipsen S.A. (IPN.PA), a biopharmaceutical company, on Thursday released new late-breaking data strengthening evidence for IQIRVO in treating primary biliary cholangitis, fatigue, and pruritis. The data from the two Phase 3 ELATIVE real-world studies was presented at the European Association for the Study of the Liver (EASL) congress.
Primary biliary cholangitis (PBC) is a rare, autoimmune liver disease where a build-up of bile and toxins causes irreversible fibrosis of the liver, chronic inflammation, and destruction of the bile ducts. The disease can be diagnosed by measuring levels of alkaline phosphatase (ALP), which increases in the blood, leading to symptoms like fatigue.
IQIRVO (elafibranor) is an oral, once-daily peroxisome proliferator-activated receptor (PPAR) agonist that acts by improving cholestasis and reducing bile toxicity. The drug received accelerated approval from the U.S. FDA for the treatment of PCB in 2024, and is also approved in the UK, Canada, Australia, Brazil, and 13 other countries.
Data from the Phase 3 ELATIVE studies indicated a clinically meaningful improvement in moderate-to-severe fatigue observed in 67% of patients. 72% of patients also showed a decrease by 15% or more in ALP levels, and 59% reported normalization of ALP levels at 52 weeks. Additionally, the global Phase 4 ELFINITY study showed a sustained regulation of ALP levels in routine clinical use, with a significant biochemical response achieved in 55% of patients within 3 months.
IPN.PA is currently trading on Euronext Paris at €156.70, down 0.89%
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