AC Immune Positive Early Data for Anti-Inflammatory Drug Strengthens Pipeline Clinical Momentum

AC Immune SA announced favorable interim Phase 1 clinical trial results for ACI-19764, an orally administered drug designed to target the NLRP3 inflammasome.

The clinical-stage biopharmaceutical company primarily focuses on developing targeted therapies for neurodegenerative diseases.

The European study evaluated the drug's safety, tolerability, and pharmacokinetics in healthy volunteers.

Early findings indicate ACI-19764 remained safe and well-tolerated across single and multiple ascending dose cohorts.

The company tested doses up to 20mg daily, noting a serum half-life exceeding 30 hours. Researchers observed no serious adverse events or treatment discontinuations during the period.

Brain Penetration and Efficacy Signals

The study demonstrated clear evidence of brain penetration through cerebrospinal fluid exposure.

Doses of 10mg daily or lower achieved pharmacokinetic concentrations exceeding the IC90 threshold. Additionally, blinded review of whole blood assays confirmed the drug successfully inhibited IL-1beta release in a dose-dependent manner.

ACI-19764 is designed to block pro-inflammatory factors and reduce chronic inflammation, which drives disease progression across multiple metabolic, inflammatory, and neurological conditions.

Phase 1b Expansion and Future Milestones

Following these positive safety results, the trial advanced to Phase 1b cohorts. Medical professionals have begun dosing patients with cardiovascular disease risk.

These participants exhibit elevated high-sensitivity C-reactive protein levels, accompanied by obesity or type 2 diabetes.

Patient enrollment remains ongoing, and the company expects to release preliminary findings from this group by year-end.

Supported by robust preclinical toxicology data, the ACI-19764 program is expected to generate additional clinical updates in the first half of 2027.

"The first-in-human data for ACI-19764 are encouraging, representing not only a significant milestone for this program but also broader clinical momentum for our wholly owned pipeline... We are now prepared to deliver key clinical evidence of anti-inflammatory activity in the coming months," said Martin Zügel, Interim CEO of AC Immune.

"We believe ACI-19764 has the potential to be a potent NLRP3 inhibitor, and we look forward to further exploring its therapeutic potential," Zügel added.

ACIU stock movement: AC Immune shares fell 4.26% to $2.47 at the time of the data release on Thursday.