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 is conducting a Phase III 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 the efficacy and safety of Elafibranor, a promising drug, in preventing disease progression and improving symptoms in PBC patients.
The intervention involves administering Elafibranor, an experimental drug, at a dose of 80 mg daily, compared to a placebo. This treatment is intended to prevent clinical outcome events indicating disease worsening, such as the need for liver transplant or death, while also evaluating the drug’s impact on symptoms like itching and tiredness.
The study is interventional, employing a randomized, parallel assignment model with triple masking (participant, investigator, outcomes assessor) to ensure unbiased results. Its primary purpose is treatment-focused, aiming to establish Elafibranor’s long-term efficacy and safety.
Key dates for this study include its start on August 31, 2023, with an estimated primary completion and last update expected by July 29, 2025. These timelines are crucial for tracking the study’s progress and anticipating results.
This clinical update could positively influence Ipsen’s stock performance and investor sentiment, as successful outcomes may position Elafibranor as a leading treatment for PBC. In a competitive pharmaceutical landscape, advancements in PBC treatment could enhance Ipsen’s market standing.
The study is ongoing, with further details available on the ClinicalTrials portal.