Dataset from A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth
factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important
breakthrough in the treatment of chronic pain and is under clinical investigation for the
treatment of pain associated with osteoarthritis or other chronic pain conditions.

The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and
2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in subjects
with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide efficacy
benefits with a favorable safety profile when administered intravenously in previous Phase 3
clinical trials. The 5 mg dose is expected to provide added efficacy benefit over the 2.5 mg
dose based on data from previous studies.

他尼珠单抗（Tanezumab）是一种可结合并抑制神经生长因子（nerve growth factor, NGF）活性的单克隆抗体（monoclonal antibody）。神经生长因子抑制剂（Nerve Growth Factor Inhibitor, NGFI）类药物有望为慢性疼痛治疗带来重要突破，目前正针对骨关节炎或其他慢性疼痛相关病症的疼痛开展临床研究。
本研究的主要研究目标为证实：针对膝或髋关节骨关节炎受试者，每8周皮下注射（subcutaneously, SC）2.5mg与5mg剂量的他尼珠单抗，在治疗第24周时的疗效优于安慰剂。既往3期临床试验显示，采用静脉给药方式给予2.5mg剂量时，该药物可在带来疗效获益的同时具备良好的安全性特征。基于既往研究数据，5mg剂量预计可较2.5mg剂量提供额外的疗效增益。