AC Immune reported that ACI-19764 reached the cerebrospinal fluid surrounding the brain and suppressed the inflammatory signal IL-1β in a dose-dependent manner in a blood assay
AC Immune reported that ACI-19764 reached the cerebrospinal fluid surrounding the brain and suppressed the inflammatory signal IL-1β in a dose-dependent manner in a blood assay
On August 20, AC Immune published interim data from the first cohorts of a study of ACI-19764 in healthy volunteers. The company assessed whether the drug reached the central nervous system, whether it achieved the target concentration there, and whether exposure was associated with a biochemical response in the blood. Enrollment has also begun in a separate cohort of people with elevated levels of the inflammatory marker hsCRP and type 2 diabetes and/or obesity.
ACI-19764 is an orally administered small molecule. AC Immune is developing it as an inhibitor of the NLRP3 inflammasome, an intracellular immune complex involved in producing inflammatory signals, including IL-1β.
In its August 20 press release, the company reported results from single-dose and multiple-dose cohorts. Cerebrospinal fluid surrounds the brain and spinal cord, so detecting ACI-19764 in this fluid shows that the drug reached the central nervous system.
The company also compared the concentration achieved with the IC90, which is the concentration of a substance that inhibits 90% of a specified response in a laboratory assay. Daily doses of up to 10 mg produced concentrations above the IC90. In whole-blood samples, IL-1β release decreased as the dose increased.
These measurements address separate questions: whether the drug reached the central nervous system, whether its concentration was sufficient to meet the laboratory target, and whether IL-1β release in the blood decreased with increasing doses.
The original protocol in the NCT07463196 registry entry includes 78 healthy volunteers. In the multiple-dose part of the study, participants take capsules daily for 14 days. The specified measurements include the drug concentration in cerebrospinal fluid and IL-1β release in whole blood.
The next cohort includes people who have elevated hsCRP, a high-sensitivity measure of C-reactive protein and a marker of inflammation in the blood, as well as cardiovascular risk associated with type 2 diabetes and/or obesity. The company plans to measure hsCRP in this group and expects the first results by the end of 2026.