27.06.2023 13:36:28
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AC Immune Announces Fast Track Designation For ACI-24.060 To Treat Alzheimer's Disease
(RTTNews) - AC Immune SA (ACIU) has received Fast Track designation from the FDA for its wholly-owned anti-amyloid beta active immunotherapy-candidate, ACI-24.060, for treatment of Alzheimer's disease. This follows FDA clearance of the Investigational New Drug application enabling expansion to the USA of the ongoing Phase 1b/2 ABATE study to include individuals with Down syndrome.
The ABATE study is a Phase 1b/2, multicenter, adaptive, double-blind, randomized, placebo-controlled study to assess the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in adults with Down syndrome.
Shares of AC Immune are up 15% in pre-market trade on Tuesday.
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