AC Immune Stock Jumps After Alzheimer's Disease Vaccine Candidate Confirms Favorable Safety, Tolerability Profile

  • AC Immune SA ACIU has completed an 18-month interim assessment of safety and tolerability in the Phase 2 study evaluating ACI-24, its vaccine candidate for mild Alzheimer's disease (AD).
  • No safety concerns or evidence for CNS inflammation or ARIA (amyloid-related imaging abnormalities) were observed, confirming earlier interim results.
  • The company will complete the Phase 2 study with the 24-month analysis based on currently enrolled patients.
  • The company is also advancing an optimized ACI-24 formulation, which demonstrates enhanced and sustained immunogenicity in preclinical studies, particularly against key pathological forms of Abeta such as oligomeric and pyroglutamate Abeta.
  • Pyroglutamate Abeta (pyroGlu-Abeta) is a highly neurotoxic form of Abeta, that is N-terminally truncated and post-translationally modified to form pyroglutamate.
  • In non-human primates, vaccination with the optimized ACI-24 vaccine generated a strong, conformation-specific antibody response against oligomeric and pyroGlu-Abeta.
  • A robust boosting effect was also observed, approximately 8-fold vs. 4-fold increase, respectively, between the 3rd and 5th injections.
  • The company plans to file an Investigational New Drug (IND) application for the optimized ACI-24 formulation by year-end, followed by clinical development in Down syndrome-related AD, with Phase 2 as early as 2022/2023.
  • Price Action: ACIU shares are up 24.2% at $7.91 during the premarket session on the last check Wednesday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsHealth CareSmall CapFDAGeneralAlzheimer's diseaseBriefsPhase 2 Trial
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!