Tharimmune, Inc. ((THAR)) announced an update on their ongoing clinical study.
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Tharimmune, Inc. (THAR) has announced a new clinical study titled ‘Evaluation of TH104 for Moderate to Severe Pruritus in Primary Biliary Cholangitis: a Double-blind, Randomized, Placebo-controlled, Phase 2a Study.’ The study aims to assess the effectiveness of TH104 in treating pruritus associated with primary biliary cholangitis (PBC), a condition characterized by chronic itching. This study is significant as it addresses a common and challenging symptom for PBC patients, potentially improving their quality of life.
The study is testing an intervention involving a drug called Nalmefene, delivered as a TH-104 mucoadhesive buccal strip, against a placebo. The purpose of this intervention is to alleviate moderate to severe pruritus in PBC patients.
This is an interventional study with a randomized allocation and a parallel intervention model. It employs triple masking, meaning that participants, care providers, and investigators are blinded to the treatment allocation. The primary purpose of the study is treatment-focused.
The study is set to begin on December 3, 2024, with an estimated completion date yet to be determined. The latest update was submitted on September 2, 2025, indicating the study is still in the planning stages and not yet recruiting participants.
For investors, this study update could have significant implications for Tharimmune’s stock performance. Successful results could enhance investor confidence and position Tharimmune as a leader in PBC treatment. However, the competitive landscape should be considered, as other companies are also exploring treatments for PBC-related pruritus.
The study is ongoing, with further details available on the ClinicalTrials portal.