瑞士Opterion公司在第一次人体试验中寻求欧盟批准新的非葡萄糖透析药物。 Swiss firm Opterion seeks EU approval for new non-glucose dialysis drug in first human trial.

瑞士生物制药公司Opterion Health AG向EMA提交了一份临床试验申请,要求对OPT101进行首次人体试验,该药物是用于腹腔透析中晚期慢性病患者的非葡萄糖治疗. Opterion Health AG, a Swiss biopharmaceutical company, has submitted a Clinical Trial Application to the EMA for a first-in-human study of OPT101, a non-glucose-based treatment for advanced chronic kidney disease patients on peritoneal dialysis. 计划中的 1 期 SPARC 试验旨在评估 OPT101 的安全性、耐受性和药代动力学，OPT101 是一种新型渗透剂，代表了三十多年来腹膜透析领域的首次重大创新。 The planned Phase 1 SPARC trial aims to assess the safety, tolerability, and pharmacokinetics of OPT101, a novel osmotic agent representing the first significant innovation in peritoneal dialysis in over three decades. 该疗法旨在解决目前基于葡萄糖的解决方案的局限性,这些解决方案可能造成代谢问题和并发症。 The therapy is designed to address limitations of current glucose-based solutions, which can cause metabolic issues and complications. 该公司还任命了两名行业领导人担任董事会董事,加强了对为选择有限的病人提供新治疗选择的重视。 The company also appointed two industry leaders to its board, reinforcing its focus on advancing new treatment options for patients with limited alternatives.