Ipsen ((GB:0MH6)) announced an update on their ongoing clinical study.
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In a recent clinical study update, Ipsen is investigating the efficacy and safety of Elafibranor in adult Japanese participants with Primary Biliary Cholangitis (PBC). This Phase III, open-label, single-arm study aims to determine if Elafibranor can effectively reduce alkaline phosphatase (ALP) and total bilirubin levels, which are indicators of liver disease. The significance of this study lies in its potential to offer a new treatment option for PBC patients who have an inadequate response or intolerance to the current standard medication, UDCA.
The intervention being tested is Elafibranor, an experimental drug administered as an 80 mg tablet taken orally once daily. It is intended to manage symptoms and slow the progression of PBC, a disease that can lead to severe liver damage and necessitate liver transplantation.
The study is designed as an interventional trial with a single-group assignment. There is no masking involved, and the primary purpose is treatment. Participants will undergo various assessments, including blood sampling and liver function tests, over a period of up to six years.
Key dates for the study include its start date on December 3, 2024, and the last update on August 27, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates on its findings.
The market implications of this study are significant for Ipsen, as positive results could enhance its stock performance and investor confidence. The introduction of Elafibranor as a viable treatment option could also impact the competitive landscape in the PBC treatment market.
The study is ongoing, with further details available on the ClinicalTrials portal.