AC Immune Reports Positive Phase 1 Data for NLRP3 Inhibitor ACI-19764
ACIU sits 30% above its 52-week low of $2.03.
Summary
AC Immune announced positive preliminary Phase 1 data for its oral NLRP3 inhibitor ACI-19764, showing safety, tolerability, and CSF penetration. A cardiovascular risk cohort is now dosing with initial results expected by year end.
Key Events · Product Development and Regulatory · ACIU
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Positive Phase 1 Data for ACI-19764
Preliminary results show ACI-19764 was safe and well tolerated across single and multiple ascending dose cohorts up to 20mg/day, with a serum half-life greater than 30 hours and confirmed CSF penetration.
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Therapeutic Dose Established
Based on PK data, the therapeutic dose is expected to be ≤10mg once daily, achieving concentrations above the IC90 with dose-dependent inhibition of IL-1beta release.
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Cardiovascular Risk Cohort Dosing Underway
Dosing of patients with cardiovascular disease risk (elevated hsCRP plus type 2 diabetes and/or obesity) has commenced, with initial anti-inflammatory activity results expected by year end.
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Full Results Expected H1 2027
Full results from the Phase 1/1b trial are expected in the first half of 2027.
Analysis · ACIU · Life Sciences
AC Immune's wholly-owned oral NLRP3 inhibitor ACI-19764 showed safety, tolerability, and confirmed brain penetration in a first-in-human Phase 1 study. The therapeutic dose is expected to be ≤10mg once daily, and dosing of a cardiovascular risk cohort is now underway with initial hsCRP results expected by year end. This validates a key wholly-owned program and expands the company's pipeline beyond partnered Alzheimer's assets, potentially supporting future partnering or advancement into Phase 2.
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At the time of this filing, ACIU was trading at $2.64 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $262.6M. The 52-week trading range was $2.03 to $4.00. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.