AC Immune initiates phase 1 study for Alzheimer’s Disease investigational treatment

AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company, today announced dosing of the first subject in a Phase 1 study of ACI-3024, a first-in-class investigational oral small molecule Tau Morphomer™ inhibitor that will be studied in neurodegenerative diseases that are characterized by the presence of pathological Tau aggregates. This is the first significant advancement in AC Immune’s collaboration with Eli Lilly and Company (NYSE:LLY).

Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “The start of this study is an important milestone for AC Immune in our collaboration with Lilly for patients suffering from debilitating neurodegenerative diseases. It demonstrates the productivity of our proprietary small molecule Morphomer™ discovery platform and further expands our robust clinical pipeline to address neurodegenerative diseases, in particular for therapeutics and diagnostics targeting Tau. Addressing Tau pathology with precision medicine is a key therapeutic strategy for Alzheimer’s disease (AD) and other neurodegenerative diseases.”

ACI-3024 is the primary focus of a license and collaboration agreement between AC Immune and Lilly to research and develop small molecule Tau aggregation inhibitors for the treatment of AD and other neurodegenerative diseases. The collaboration combines AC Immune’s proprietary Morphomer™ discovery platform and early development experience with Lilly’s established clinical development expertise and commercial capabilities in central nervous system disorders. AC Immune will conduct the initial Phase 1 development of the Morphomer™ Tau aggregation inhibitors while Lilly will fund and conduct further clinical development.

The Phase 1 trial is a randomized, placebo controlled, double blind, sequential single and multiple ascending dose study with open label food effect and pharmacodynamics assessment arms to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACI-3024 in healthy volunteers.

Dr. Sonia Poli, Vice President Translational Science and Project Leader of AC Immune SA, commented: “In the complex treatment paradigm for AD, Tau pathology is a potential therapeutic target because Tau spreads with a characteristic spatiotemporal pattern throughout the brain that coincides with both clinical symptoms and disease progression in AD. Slowing the propagation of Tau pathology may slow disease progression and reduce cognitive decline. Anti-Tau therapies already have shown promise in slowing the progression of Tau pathology in animal models.”

About the AC Immune and Eli Lilly and Company Agreement
Lilly will receive worldwide commercialization rights for successful Tau aggregation inhibitors in the area of Alzheimer's disease. AC Immune has retained certain development rights in orphan indications and co-development and co-promotion options in certain indications outside AD.