Alzheimer’s vaccine granted Fast Track designation

The US FDA has given Fast Track designation to an active immunotherapy vaccine that “specifically targets the most toxic forms of amyloid beta (Abeta)”.

Anti-Abeta Alzheimer’s vaccine granted Fast Track designation

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

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

The anti-Abeta therapy “specifically targets the most toxic forms of Abeta” according to Dr Andrea Pfeifer, CEO of AC Immune SA. 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,” 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 noted.

Therefore “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 Alzheimer’s and Down’s syndrome-related Alzheimer’s,” Dr Rafii added.

Developing an effective Alzheimer’s vaccine

Given the more predictable onset and progression of symptoms in Down’s syndrome-related Alzheimer’s, AC Immune stated ABATE’s results will offer important data into the ability of ACI-24.060 active immunotherapy to modulate neurodegeneration at its earliest stages and offer these patients a much-needed therapeutic option.

“Despite representing the world’s largest population that is genetically at high risk for Alzheimer’s, individuals with Down’s syndrome are vastly underserved and underrepresented in clinical trials,” Dr Rafii highlighted.

With Fast Track designation, AC Immune SA “remain firmly on track to report additional interim safety and immunogenicity data later this year, and for the crucial interim readout of Abeta-PET imaging data in AD in the first half of next year,” Dr Johannes Streffer, Chief Medical Officer of AC Immune SA responded.

Download EPR’s Issue 3 2023 to read AC Immune’s article on vaccine development: Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review Issue 3 2023