生物技术公司Tharimmune获得了EMA的批准,用于治疗初级胆道胆炎的候选TH104的第二阶段试验. Biotech firm Tharimmune gains EMA approval for Phase 2 trial of candidate TH104 in treating primary biliary cholangitis.
生物技术公司 Tharimmune 从欧洲药品管理局 （EMA） 获得了关于其候选药物 TH104 的有利见解，该候选药物旨在治疗原发性胆汁性胆管炎 （PBC） 中的中度至重度瘙痒。 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). EMA核可了第二阶段试验,并可能使用混合应用来参考现有安全数据,指出没有必要再进行动物研究。 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 计划很快开始试验，预计将于 2025 年获得顶线结果。 Tharimmune plans to start the trial soon, with topline results expected in 2025.