Ipsen ((GB:0MH6)), Ipsen (($CC:IPN.CUR)) announced an update on their ongoing clinical study.
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In a significant advancement for the treatment of Primary Biliary Cholangitis (PBC), Ipsen has initiated a Phase III clinical study titled ‘A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)’. The study aims to assess whether Elafibranor can effectively prevent disease progression and improve clinical outcomes in PBC patients, a condition that can lead to liver transplant or death if untreated.
The intervention under investigation is Elafibranor, an experimental drug administered as an 80 mg tablet daily. It is designed to halt disease progression and improve symptoms such as itching and fatigue in PBC patients. The study will compare this treatment to a placebo over a period of up to 3.5 years.
This interventional study employs a randomized, parallel assignment model with triple masking (participant, investigator, outcomes assessor) to ensure unbiased results. The primary purpose is treatment-focused, aiming to establish the long-term efficacy and safety of Elafibranor.
The study began on August 31, 2023, with primary completion and estimated completion dates set for the future. The last update was submitted on July 29, 2025, indicating ongoing recruitment and data collection.
The implications of this study for Ipsen’s market performance are notable. Success in this trial could enhance Ipsen’s portfolio in the competitive PBC treatment market, potentially boosting investor confidence and stock value. The study’s progress is crucial, given the competitive landscape with other pharmaceutical companies also targeting liver diseases.
The study is currently ongoing, with further details accessible on the ClinicalTrials portal.