ACI-19764 / AC Immune - LARVOL DELTA

A Study Investigating the Safety, Absorption, Elimination, and the Effect on the Immune System of ACI-19764 in Healthy Participants (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: AC Immune SA

New P1 trial

ACI-19764-2501: A Single-Center, Double-Blind, Randomized, Placebo Controlled Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses of ACI-19764 in Healthy Participants (clinicaltrialsregister.eu) - P1 | N=78 | Recruiting | Sponsor: AC Immune S.A.

New P1 trial

AC Immune SA…announced that the first participant has been dosed in a Phase 1 clinical trial of ACI-19764, an orally administered small molecule inhibitor of the NLRP3 inflammasome (GlobeNewswire) - "Initial data from the Phase 1 trial are expected in the second half of 2026."

P1 data • Trial status • Immunology • Inflammation

AC Immune Reports Third Quarter 2025 Financial Results and Provides a Corporate Update (GlobeNewswire) - "IND/CTA filing for small molecule NLRP3 inhibitor ACI-19764 and the start of IND-enabling studies for Morphomer-Tau aggregation inhibitor both expected by year-end...'We are now moving towards multiple value-inflection points. Further interim results from Part 1 of the VacSYn trial of ACI-7104.056, our wholly owned anti-alpha-synuclein active immunotherapy for Parkinson’s disease, are expected this quarter.'...'This technology also powers our ACI-24.060 anti-Abeta active immunotherapy program, for which additional results are expected in H1 next year.'...TDP-43-PET tracer: Initial Phase 1 readout in genetic frontotemporal dementia (FTD): Q4 2025....ACI-15916 a-syn-PET tracer: Phase 1 readout in Parkinson’s disease (PD): Q4 2025."

Clinical data • IND • Alzheimer's Disease • Frontotemporal Lobar Degeneration • Parkinson's Disease

AC Immune Reports Second Quarter 2025 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Three active immunotherapies for precision prevention of neurodegeneration progressing through Phase 2 clinical development; ACI-7104.056 anti-alpha-synuclein active immunotherapy in Parkinson’s disease produced strong immunogenicity and favorable safety profile in interim results from the ongoing Phase 2 VacSYn...with further data to come in H2 2025; Third Alzheimer’s disease cohort (AD3) in the Phase 2 ABATE trial of anti-Abeta ACI-24.060 to reach 12 months of treatment in December 2025, with interim results expected early 2026....'We also expect to file an IND for ACI-19764 this year.'"

Clinical data • IND • Alzheimer's Disease • Parkinson's Disease

AC Immune Reports Full Year 2024 Financial Results and Provides a Corporate Update (GlobeNewswire) - "ACI-19764 small molecule NLRP3 inhibitor is undergoing in vivo proof of concept with results expected in 2025 anticipated to enable investigational new drug (IND) application. Our Morphomer Tau and Morphomer a-syn small molecule aggregation inhibitors have made steady progress with selection of lead candidates expected in 2025."

Pipeline update • Preclinical • CNS Disorders