Clinical Trials

AC Immune is pursuing clinical development with ACI-24.060, an optimized formulation of ACI-24, which is intended to prime, boost and maintain a strong antibody response against key pathological Abeta species (including oligomeric and pyroglutamate Abeta; Vukicevic M. et al., Brain Communications, 2022).

This Phase 1b/2 study, ABATE, will evaluate the active immunotherapy candidate in early Alzheimer’s disease and the target population will consist of both patients with Alzheimer’s disease and people living with Down syndrome, with evidence of presence of brain amyloid pathology.

ABATE is a multicenter adaptive, double-blind, placebo-controlled study that will assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060.

Key outcome measures for the study will include assessments of safety, immunogenicity, pharmacodynamics, Abeta-PET imaging, and target engagement.

http://www.clinicaltrials.gov/study/NCT05462106

View our Expanded Access Policy for ACI-24.060

Our wholly owned candidate ACI-7104.056 is an optimized formulation designed to induce a-syn-specific antibodies recognizing aggregated a-syn species that are toxic to neurons.

Building on the strong Phase 1 data of the predecessor active immunotherapy (Volc D. et al., Lancet Neurol., 2020), ACI-7104.056 has advanced into an adaptive, biomarker-based Phase 2 study in early Parkinson’s disease.

This Phase 2 study has two parts: in the first part, we utilize biomarker-based interim analyses to tailor the dosing regimen and monitor the disease-specific biomarkers.

In part two, the goal is to generate clinical proof-of-concept in early Parkinson’s disease and to monitor the progression of motor and non-motor symptoms, as well as digital, imaging, and fluid biomarkers.

Our anti-Tau monoclonal antibody, semorinemab, is designed to slow the spreading of Tau pathology, which correlates with clinical symptoms and disease progression in Alzheimer’s disease.

A Phase 2 trial (TAURIEL) demonstrated safety, tolerability and target engagement but a lack of clinical effect in prodromal-to-mild Alzheimer’s disease (Teng E. et al., CTAD 2020).

LAURIET, a Phase 2 study, was evaluating semorinemab in mild-to-moderate Alzheimer’s disease. Top-line data showed a statistically significant reduction on one of two co-primary endpoints, ADAS-Cog11, providing the first positive cognitive results for an anti-Tau antibody therapy in Alzheimer’s disease. The second co-primary endpoint, ADCS-ADL, and secondary endpoints were not met. Semorinemab was well tolerated with no unanticipated safety signals.

The primary completion was accomplished in 2021 and further analyses are ongoing.

The Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study was evaluating the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of semorinemab in 260 patients with mild-to-moderate Alzheimer’s disease. The primary objectives were to assess cognitive function and functional capacities.

http://www.clinicaltrials.gov/ct2/show/NCT03828747

In collaboration with our partner, Eli Lilly & Co., we are researching and developing small molecule Tau aggregation inhibitors with plans to evaluate candidates in Alzheimer’s disease and NeuroOrphan indications.

In 2020, a Phase 1 clinical study in healthy volunteers was completed. It showed a dose-dependent exposure and brain penetration, achieving the desired levels of ACI-3024 in the CSF.

In addition to Alzheimer’s disease, the program is planned to be expanded to NeuroOrphan indications and candidates will be further evaluated for efficacy in models of rare Tauopathies.

Continued candidate characterization across the research program has also identified new and highly differentiated candidates with excellent cerebrospinal fluid exposure and selectivity for pathological aggregated Tau. These will be assessed for their further development in Tau-dependent neurodegenerative diseases.

Our next-generation PET tracer has shown significant potential to reliably detect and map deposits of the pathological form of a-synuclein protein in the brain and was advanced into clinical development in 2021.

Supported by the Michael J. Fox Foundation for Parkinson’s Research, a First-in-Human study and an investigator-initiated study were begun in 2021 and evaluate the imaging tracer’s characteristics as a diagnostic tool in patients with Parkinson’s disease, multiple system atrophy (MSA) and other a-synucleinopathies.