AC Immune SA, a Swiss-based biotech, announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its Alzheimer’s disease treatment called ACI-24.060. The vaccine is an anti-amyloid beta (Abeta) active immunotherapy candidate with the aim of treating serious illnesses in patients with unmet medical needs.
The company was cleared by the FDA for its investigational New Drug application which allows it to expand to its current Phase 1b/2 ABATE study in patients with Alzheimer’s disease and individuals with Down Syndrome. The first individual with Down Syndrome has already been dosed and safety and immunogenicity data for both cohorts are expected to be available in the second half of 2023.
After years of research, this designation by the FDA reinforces the potential of AC Immune’s innovative approach to treating Alzheimer’s disease. Despite the 2% year-to-date drop in AC Immune’s stock, the company remains optimistic about the future results of its research.
With the new FDA fast-track designation, AC Immune is on track to potentially advance its treatment options to patients in the near future.