On 15 February, AC Immune, a clinical-stage biopharmaceutical company focused on neurodegenerative diseases, announced new interim data from its Phase Ib/IIa trial evaluating ACI-35.030 in early Alzheimer’s disease (AD). The Phase Ib/IIa study is a randomised, multicenter, double-blind and placebo-controlled clinical trial evaluating the safety, tolerability and immunogenicity of different dosages of ACI-35.030 and JACI-35.054 in people with early AD. ACI-35.030 is a vaccine designed to stimulate the generation of antibodies to pTau, which should bind to pathological Tau proteins in the brain and target them for clearance by the immune system.
The new findings, focused on the high-dose cohort of ACI-35.030, showed that at 10 weeks, the treatment led to a strong induction of antibodies selective for pTau and its aggregated form. These results were consistent with those previously announced for the trial’s mid-dose. ACI-35.030 continues to be well tolerated with no clinically relevant safety concerns observed with all doses. The study had already been expanded to include a total of 24 people with AD in the mid-dose cohort to generate additional data on immunogenicity and safety.