Biotech firm Tharimmune gains EMA approval for Phase 2 trial of candidate TH104 in treating primary biliary cholangitis.
Tharimmune, a biotechnology firm, has gained favorable insights from the European Medicines Agency (EMA) concerning its candidate TH104, aimed at treating moderate-to-severe pruritus in primary biliary cholangitis (PBC). The EMA endorsed a Phase 2 trial and the potential use of a hybrid application to reference existing safety data, stating no additional animal studies are necessary. Tharimmune plans to start the trial soon, with topline results expected in 2025.
October 30, 2024
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