I'm LongbridgeAI, I can summarize articles.AC Immune reported favorable interim Phase 1 results for ACI-19764, an oral NLRP3 inhibitor. The drug demonstrated strong safety, brain penetration, and dose-dependent inhibition of IL-1beta in healthy volunteers. Consequently, the trial advanced to a Phase 1b cohort targeting patients with cardiovascular risk factors. Initial findings for this group are expected before year-end, with further updates anticipated in H1 2027.
AC Immune SA (NASDAQ:ACIU) reported 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 conditions.
The European study evaluates the drug’s safety, tolerability, and pharmacokinetics in healthy volunteers.
Early findings indicate that ACI-19764 remains safe and well-tolerated across single and multiple ascending dose groups.
The company tested doses up to 20mg daily, noting a serum half-life exceeding 30 hours. Researchers observed no serious adverse events or treatment withdrawals during this period.
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Brain Penetration And Efficacy Signals
The study showed clear evidence of brain penetration through cerebrospinal fluid exposure.
Daily doses of 10mg or less reached pharmacokinetic concentrations above the IC90 threshold. Furthermore, a blinded review of whole blood assays confirmed that the drug successfully inhibited IL-1beta release in a dose-dependent manner.
ACI-19764 aims to block pro-inflammatory factors and lower chronic inflammation, which drives disease progression across multiple metabolic, inflammatory, and neurological disorders.
Phase 1b Expansion and Future Milestones
Following these positive safety outcomes, the trial advanced to a Phase 1b cohort. Medical professionals have started dosing patients at risk for cardiovascular disease.
These participants exhibit elevated high-sensitivity C-reactive protein levels, alongside obesity or type 2 diabetes.
Patient recruitment remains active, and the company anticipates releasing initial findings for this group before the year ends.
Backed by robust preclinical toxicity data, the ACI-19764 program expects to yield additional clinical updates in the first half of 2027.
“These first-in-human data for ACI-19764 are encouraging, and represent not only an important milestone for this program, but also the wider clinical momentum of our wholly-owned programs…we are now poised to deliver key clinical evidence of anti-inflammatory activity (hsCRP inhibition) in the coming months.” Martin Zügel, interim CEO of AC Immune, commented.
We believe ACI-19764 has the potential to be a powerful NLRP3 inhibitor, and we look forward to further exploring its therapeutic potential,” Zügel further added.
ACIU Price Action: AC Immune shares were down 4.26% at $2.47 at the time of publication on Thursday, according to Benzinga Pro data.
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