AC Immune's anti-inflammatory therapy has netted a Phase I, first-in-human win in healthy volunteers, setting a positive precedent as the Swiss biopharma company begins dosing patients.
In the early-stage, European study (NCT07463196), AC Immune set out to evaluate ACI-19764's pharmacokinetics (PK), tolerability, safety and pharmacodynamics (PD) in healthy volunteers – with preliminary results revealing that the drug was safe and well tolerated. The drug's profile remained favourable across cohorts receiving both single and multiple increasing doses of up to 20mg per day, AC Immune claims.
Individuals receiving ACI-19764 also experienced no severe adverse events (AEs) linked to the drug, and no patient has yet discontinued treatment.
Alongside its promising safety profile, researchers identified that ACI-19764 was able to penetrate the blood-brain barrier, as evidenced by the presence of the drug in the spinal fluid of dosed participants. This will be welcome news for AC Immune as it looks to explore the therapy's potential in certain neurodegenerative diseases, as central nervous system (CNS) penetration will likely be necessary to provide localised benefit.
Researchers also identified early signs of ACI-19764's target engagement, as the drug triggered a dose-dependent impact on the release of IL-1β. IL-1β is a pro-inflammatory cytokine that operates downstream of the NLRP3 inflammasome, which orally administered ACI-19764 is designed to inhibit. By modulating inflammation in the body, AC Immune theorises that the drug could be used to treat many disorders driven by inflammation such as metabolic and neurological diseases.
Following the positive early signals in healthy volunteers, AC Immune has started dosing its first patients, who all have either type 2 diabetes and/or obesity and are at risk of cardiovascular disease – as defined by high levels of a specific protein associated with inflammation in the body. The biopharma expects to debut full results from the Phase I/Ib study in the first half of 2027.
In a research note, Jefferies analysts tout the early Phase I data as providing "encouraging validation" of ACI-19764's activity due to its ability to penetrate the CNS, initially engage with its target and potentially demonstrate efficacy at a low dose once daily.
However, they note that this programme remains very much in its early stages, meaning relative competitiveness remains unclear, so focus will now shift to initial Phase Ib data.
In a previous conversation with Clinical Trials Arena's sister publication, Pharmaceutical Technology, multiple drug developers in the Alzheimer's space pointed to the promise of modulating neuroinflammation as a disease-modifying approach in the condition.
"AC Immune's anti-inflammatory drug posts early-stage win" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.