AC Immune Phase 1 Data Highlights
AC Immune SA (NASDAQ: ACIU) reported that its oral NLRP3 inflammasome inhibitor ACI‑19764 was safe and well tolerated in single and multiple ascending‑dose cohorts of healthy volunteers in Europe. No serious adverse events or treatment withdrawals were observed. Pharmacokinetic assessment showed a serum half‑life exceeding 30 hours and confirmed brain penetration via cerebrospinal fluid exposure. Daily doses of 10 mg or less produced plasma concentrations above the IC90, and blinded whole‑blood assay data demonstrated dose‑dependent inhibition of IL‑1β release. Based on these data, the anticipated therapeutic dose is 10 mg or less once daily; the single ascending‑dose cohort evaluated doses up to 20 mg per day.
The Phase 1 programme has now begun dosing a Phase 1b cohort of patients at cardiovascular‑disease risk, defined by elevated high‑sensitivity C‑reactive protein and the presence of type 2 diabetes or obesity. Initial results from this cohort are expected by the end of the calendar year, with complete Phase 1/1b results slated for the first half of 2027.
In vitro, ACI‑19764 displayed high potency, inhibiting IL‑1β production in human macrophages and whole blood with an IC50 ranging from 2 nM to 20.5 nM. The drug targets the NLRP3 inflammasome to reduce chronic inflammation implicated in multiple inflammatory, metabolic, and neurological disorders.
Following the announcement, AC Immune shares rose 3.9 % in pre‑market trading.