Tharimmune, Inc. announced on December 16, 2024, its plans for initiating a Phase 2 study evaluating TH104 in patients suffering from moderate-to-severe pruritus associated with primary biliary cholangitis (PBC). PBC is a rare and chronic liver disease.
The launch of this clinical trial is expected in 2025 and follows favorable results from Tharimmune's Phase 1 study with TH104. The decision also incorporates recent positive regulatory feedback received from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Progress on manufacturing clinical study supply has also been made, supporting the readiness for the Phase 2 trial. This advancement represents a significant step forward in the clinical development of TH104 for its initial indication.
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