Yu Sifan, Li Dijie, Zhang Ning, Ni Shuaijian, Sun Meiheng, Wang Luyao, Xiao Huan, Liu Dingdong, Liu Jin, Yu Yuanyuan, Zhang Zongkang, Yeung Samuel Tin Yui, Zhang Shu, Lu Aiping, Zhang Zhenlin, Zhang Baoting, Zhang Ge
Law Sau Fai Institute for Advancing Translational Medicine in Bone and Joint Diseases, School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tsai, Hong Kong 999077, China.
Institute of Integrated Bioinfomedicine and Translational Science, School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tsai, Hong Kong 999077, China.
Acta Pharm Sin B. 2022 May;12(5):2150-2170. doi: 10.1016/j.apsb.2022.01.012. Epub 2022 Jan 21.
Sclerostin, a protein secreted from osteocytes, negatively regulates the WNT signaling pathway by binding to the LRP5/6 co-receptors and further inhibits bone formation and promotes bone resorption. Sclerostin contributes to musculoskeletal system-related diseases, making it a promising therapeutic target for the treatment of WNT-related bone diseases. Additionally, emerging evidence indicates that sclerostin contributes to the development of cancers, obesity, and diabetes, suggesting that it may be a promising therapeutic target for these diseases. Notably, cardiovascular diseases are related to the protective role of sclerostin. In this review, we summarize three distinct types of inhibitors targeting sclerostin, monoclonal antibodies, aptamers, and small-molecule inhibitors, from which monoclonal antibodies have been developed. As the first-in-class sclerostin inhibitor approved by the U.S. FDA, the monoclonal antibody romosozumab has demonstrated excellent effectiveness in the treatment of postmenopausal osteoporosis; however, it conferred high cardiovascular risk in clinical trials. Furthermore, romosozumab could only be administered by injection, which may cause compliance issues for patients who prefer oral therapy. Considering these above safety and compliance concerns, we therefore present relevant discussion and offer perspectives on the development of next-generation sclerostin inhibitors by following several ways, such as concomitant medication, artificial intelligence-based strategy, druggable modification, and bispecific inhibitors strategy.
硬化素是一种由骨细胞分泌的蛋白质,它通过与低密度脂蛋白受体相关蛋白5/6(LRP5/6)共受体结合来负向调节WNT信号通路,进而抑制骨形成并促进骨吸收。硬化素与肌肉骨骼系统相关疾病有关,这使其成为治疗WNT相关骨疾病的一个有前景的治疗靶点。此外,新出现的证据表明硬化素与癌症、肥胖症和糖尿病的发生发展有关,这表明它可能是这些疾病的一个有前景的治疗靶点。值得注意的是,心血管疾病与硬化素的保护作用有关。在这篇综述中,我们总结了三种针对硬化素的不同类型抑制剂,即单克隆抗体、适配体和小分子抑制剂,其中单克隆抗体已得到开发。作为美国食品药品监督管理局(FDA)批准的首个同类首创硬化素抑制剂,单克隆抗体罗莫佐单抗在治疗绝经后骨质疏松症方面已显示出卓越的疗效;然而,它在临床试验中带来了较高的心血管风险。此外,罗莫佐单抗只能通过注射给药,这可能会给倾向于口服治疗的患者带来依从性问题。考虑到上述安全性和依从性问题,我们因此通过几种方式,如联合用药、基于人工智能的策略、可成药修饰和双特异性抑制剂策略,对下一代硬化素抑制剂的开发进行了相关讨论并提供了观点。