Ipsen ((GB:0MH6)), Ipsen (($CC:IPN.CUR)) announced an update on their ongoing clinical study.
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Study Overview: Ipsen is conducting a Phase III clinical trial titled A Phase III, Open-label, Single Arm Study to Investigate the Efficacy and Safety of Elafibranor 80 mg in Adult Japanese Participants With Primary Biliary Cholangitis (PBC). The study aims to evaluate the safety and efficacy of elafibranor in reducing alkaline phosphatase and bilirubin levels in patients with PBC, a progressive liver disease that can lead to cirrhosis and potentially require liver transplantation.
Intervention/Treatment: The study tests elafibranor, an 80 mg oral drug, administered daily to participants. Elafibranor is intended to manage PBC by lowering harmful liver enzyme levels.
Study Design: This interventional study follows a single-group assignment model with no masking, focusing on treatment as its primary purpose. All participants receive the experimental drug, elafibranor, to assess its effects.
Study Timeline: The study began on January 16, 2025, with primary completion and estimated completion dates yet to be announced. The latest update was submitted on July 31, 2025, indicating ongoing recruitment and progress.
Market Implications: The study’s progress could influence Ipsen’s stock performance positively if elafibranor proves effective, potentially positioning the company as a leader in PBC treatment. This development may also impact investor sentiment, especially if competitors lack similar advancements in their pipelines.
The study is currently ongoing, with further details available on the ClinicalTrials portal.