Alzheimer’s Disease Immunotherapy Receives Fast Track Designation

AC Immune SA today announced that it had received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy (vaccine)-candidate, ACI-24.060, for the treatment of Alzheimer’s disease (AD).

Confirmed on June 27, 2023, this news follows FDA clearance of the Investigational New Drug (IND) application enabling expansion to the USA of the ongoing Phase 1b/2 ABATE study of ACI-24.060 in patients with AD and individuals with Down syndrome (DS).

Furthermore, the first individual with DS has been dosed in ABATE.

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 clinical trial, commented in a press release, “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 applaud AC Immune for seeking to address the urgent needs of this population and 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.”

Alzheimer's vaccine candidates are not FDA-approved as of June 27, 2023.