ACI-19764

August 20, 2026: AC Immune SA (NASDAQ: ACIU) reported positive preliminary Phase 1/1b first-in-human data for ACI-19764, an oral NLRP3 inflammasome inhibitor. In healthy volunteers, the drug was safe and well tolerated across single-ascending and multiple-ascending dose cohorts, with no serious adverse events or treatment withdrawals reported to date. Doses up to 20 mg/day were studied in SAD, serum half-life was greater than 30 hours, and cerebrospinal fluid exposure confirmed brain penetration.

The company said daily doses of 10 mg or less achieved PK concentrations above IC90, supporting an expected therapeutic dose of 10 mg once daily or below. A blinded whole-blood assay showed dose-dependent inhibition of IL-1β release.

A Phase 1b cardiovascular-risk cohort is now being dosed to assess anti-inflammatory activity via hsCRP in patients with elevated hsCRP plus type 2 diabetes and/or obesity; recruitment is ongoing. Initial Phase 1b results are expected before year-end, and full Phase 1/1b results are expected in H1 2027.