智通财经APP讯，英硅智能(03696)发布公告，本公司与深圳衡泰生物科技有限公司(衡泰生物)共同开发的创新口服NLRP3抑制剂ISM8969/HT-001已获得中国国家药品监督管理局(NMPA)新药临床试验批准，用于治疗帕金森病。继于2026年6月宣布在澳洲I期研究中进行的首例人体给药后，此项批准标志着中国和澳洲两地平行临床评估的正式开展。
本次临床试验旨在评估ISM8969/HT-001在健康参与者群体中的安全性、耐受性、药代动力学(PK)和药效动力学(PD)特征，以及其在帕金森病患者中的初步疗效，为其后续临床开发奠定基础。
在临床前评估研究中，ISM8969/HT-001展现出均衡的成药性特征，包括良好的体外活性与安全性、优异的体内PK/PD特征，以及在多个小鼠疾病模型中对炎症的疗效，这些模型涵盖急性炎症性疾病和慢性疾病。与其他临床进展较快但具外周限制性的NLRP3抑制剂相比，ISM8969/HT-001能够穿透血脑屏障并进入中枢神经系统，因此有望用于治疗与神经炎症相关的疾病。
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