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Drug Development.

Jiong Shi1, Yun Xu2, Shenyu Zhao3

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SHR-1707, an antibody targeting amyloid-beta, is being evaluated for long-term efficacy and safety in Alzheimer's patients. This Phase 2 trial will assess its impact on amyloid deposition and cognitive function over 78 weeks.

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Area of Science:

  • Neurology
  • Immunology
  • Pharmacology

Background:

  • SHR-1707 is a humanized IgG1 monoclonal antibody targeting amyloid-beta (Aβ) with demonstrated in vitro affinity for Aβ species and in vivo efficacy in an Alzheimer's disease (AD) mouse model.
  • Phase 1 studies indicated SHR-1707 is safe and well-tolerated in healthy adults and elderly subjects.
  • A Phase 1b trial showed SHR-1707 was generally well-tolerated in patients with mild cognitive impairment (MCI) due to AD or mild AD, reducing amyloid in a dose-dependent manner.

Purpose of the Study:

  • To investigate the long-term efficacy and safety of SHR-1707 in patients with MCI due to AD or mild AD.
  • To evaluate the effect of SHR-1707 on cerebral Aβ deposition over 78 weeks.
  • To assess the safety and tolerability of SHR-1707 during an extended treatment period.

Main Methods:

  • A randomized, double-blind, placebo-controlled Phase 2 study (NCT06199037) involving patients aged 50-85 with MCI due to AD or mild AD.
  • Participants were randomized (2:1) to receive intravenous SHR-1707 (10 mg/kg Q2W) or placebo for 26 weeks, stratified by ApoE ε4 status.
  • An open-label extension allowed continued treatment with SHR-1707 for 52 weeks, with primary endpoint being change in cerebral Aβ deposition via PET imaging at Week 26.

Main Results:

  • The study is currently ongoing in China.
  • Topline results are anticipated in the second quarter of 2025.

Conclusions:

  • The ongoing Phase 2 study aims to provide crucial data on the long-term therapeutic potential of SHR-1707.
  • Findings will elucidate the sustained impact of SHR-1707 on amyloid pathology and clinical outcomes in AD patients.