Research and Development Department, Chiesi Farmaceutici, Parma, Italy.
Expert Rev Clin Immunol. 2012 Feb;8(2):135-49. doi: 10.1586/eci.11.93.
Solanezumab (LY2062430) is a humanized monoclonal antibody that binds to the central region of β-amyloid, a peptide believed to play a key role in the pathogenesis of Alzheimer's disease (AD). Eli Lilly & Co is developing an intravenous formulation of solanezumab for the treatment of mild-to-moderate AD. Acute and subchronic treatment with solanezumab of transgenic mice attenuated or reversed memory deficits with no effects on incidence or severity of cerebral amyloid angiopathy-associated microhemorrhages, a severe side effect associated with bapineuzumab, another monoclonal antibody. Phase II studies in AD patients have shown a good safety profile with encouraging indications on cerebrospinal and plasma biomarkers. The drug is currently being investigated in Phase III trials. While there is a strong hope that solanezumab may represent the first effective passive vaccine for AD treatment, skepticism still exists on the ability of the drug to slow the rate of deterioration in patients with fully established disease.
Solanezumab(LY2062430)是一种人源化单克隆抗体,可与β-淀粉样蛋白的中心区域结合,这种肽被认为在阿尔茨海默病(AD)的发病机制中起关键作用。礼来公司正在开发一种用于治疗轻度至中度 AD 的静脉内制剂。对转基因小鼠进行的 solanezumab 急性和亚慢性治疗减轻或逆转了记忆缺陷,对与 bapineuzumab(另一种单克隆抗体)相关的脑淀粉样血管病相关微出血的发生率或严重程度没有影响,这是一种严重的副作用。AD 患者的 II 期研究显示出良好的安全性,脑脊液和血浆生物标志物有令人鼓舞的迹象。该药物目前正在 III 期试验中进行研究。尽管人们强烈希望 solanezumab 可能成为治疗 AD 的首个有效被动疫苗,但该药是否能减缓已确诊患者疾病恶化的速度仍存在怀疑。