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AC Immune ACI-35.030 Phase 1b/2a Trial Interim Data Confirm Consistent Safety and Potent Immunogenicity of pTau Alzheimer’s Vaccine in High-dose Cohort
Observed strong induction of antibodies specific for pathological forms of Tau with ACI-35.030 treatment ACI-35.030 continues to be well tolerated with no
About this update from Ac Immune Sa
[{"type":"text","content":"Observed strong induction of antibodies specific for pathological forms of Tau with ACI-35.030 treatment ACI-35.030 continues to be well tolerated with no clinically relevant safety concerns observed in low-, mid- or high-dose cohorts to date Interim data support plans for further late-stage development LAUSANNE, Switzerland, Feb. 15, 2022 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced new interim 10-week data from the high-dose cohort of a placebo-controlled Phase 1b/2a trial evaluating ACI-35.030, a first-in-class phosphorylated-Tau (pTau) vaccine candidate in participants with early Alzheimer’s disease (AD). The Company previously reported interim data from low-dose and mid-dose cohorts. ACI-35.030, based on AC Immune’s SupraAntigen® platform, is the first AD vaccine candidate designed to generate antibodies targeting pathological pTau in the brain. New interim data from the Phase 1b/2a trial show that the high-dose of ACI-35.030 led to the strong induction of antibodies selective for pTau and its aggregated form, enriched paired helical filaments (ePHF). These data are consistent with those previously announced for the trial’s mid-dose cohort that showed median anti-pTau antibody titers increasing from baseline by two orders of magnitude at week 2 after a first injection. Additional key findings from the high-dose interim analysis include: Results indicate that the induced immune response selectively targets pTau, as shown by an increase in the anti-pTau/anti-Tau IgG ratio over time up to week 10.In this interim data set to week 10, median levels of antibodies reactive with pathological Tau (ePHF) were boosted with both the first and second vaccine injections.Safety data provide further support for ACI-35.030’s favorable safety and tolerability profile, as no clinically relevant safety concerns have been observed to date. As previously announced, the ongoing Phase 1b/2a study has been expanded to include a total of 24 AD participants in the mid-dose sub-cohort. This expansion was designed to generate additional immunogenicity and safety data. Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “These latest interim results add to the robust clinical dataset supporting plans for continued la...