FDA fast-tracks immunotherapy for Alzheimer’s disease

Neurons in a brain with Alzheimer's disease

AC Immune has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy (vaccine)-candidate, ACI-24.060, for treatment of Alzheimer’s disease (AD).

This follows FDA clearance of the Investigational New Drug (IND) application enabling expansion to the USA of the ongoing Phase Ib/II ABATE study of ACI-24.060 in patients with AD and individuals with Down syndrome (DS).

Dr Andrea Pfeifer, CEO of AC Immune SA, commented: “By inducing a polyclonal response including antibodies against both oligomeric Abeta and pyroglutamate-Abeta, ACI-24.060 targets the same toxic species as disease modifying anti-Abeta monoclonal antibodies that slowed AD progression in Phase III clinical trials.”

ACI-24.060’s Fast Track designation and IND clearance, as well as the expansion of ABATE to include individuals with DS were supported by positive initial interim safety and immunogenicity data from ABATE’s first, low dose AD cohort. Dosing in a second, higher dose AD cohort began earlier this year.

Dr Michael Rafii, Medical Director of the Alzheimer’s Therapeutic Research Institute, Professor of Neurology at the Keck School of Medicine, and the Principal Investigator of the trial commented: “Despite representing the world’s largest population that is genetically at high risk for AD, individuals with DS are vastly underserved and underrepresented in clinical trials. I believe ACI-24.060 holds great promise as a novel therapy that can lower Abeta plaques to delay, or perhaps even prevent, the onset of clinical dementia symptoms in AD and DS-related AD.

“Moreover, I believe the potential safety, efficacy, and logistical advantages of a vaccine over monoclonal antibodies strongly support the development of therapeutics such as ACI-24.060 as the next generation of anti-Abeta therapies.”

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