We are analyzing https://link.springer.com/article/10.1007/s00228-021-03149-2.

Title:
A phase I study assessing the safety, tolerability, immunogenicity, and low-density lipoprotein cholesterol-lowering activity of immunotherapeutics targeting PCSK9 | European Journal of Clinical Pharmacology
Description:
Purpose AT04A and AT06A are two AFFITOPE® peptide vaccine candidates being developed for the treatment of hypercholesterolemia by inducing proprotein convertase subtilisin/kexin type 9 (PCSK9)-specific antibodies. This study aimed to investigate safety, tolerability, antibody development, and reduction of low-density lipoprotein cholesterol (LDLc) following four subcutaneous immunizations. Methods This phase I, single-blind, randomized, placebo-controlled study was conducted in a total of 72 healthy subjects with a mean fasting LDLc level at baseline of 117.1 mg/dL (range 77–196 mg/dL). Each cohort enrolled 24 subjects to receive three priming immunizations at weeks 0, 4, and 8 and to receive a single booster immunization at week 60 of either AT04A, AT06A, or placebo. In addition to safety (primary objective), the antigenic peptide- and PCSK9-specific antibody response and the impact on LDLc were evaluated over a period of 90 weeks. Results The most common systemic treatment-related adverse events (AEs) reported were fatigue, headache, and myalgia in 75% of subjects in the AT06A group and 58% and 46% of subjects in the placebo and AT04A groups, respectively. Injection site reactions (ISR) representing 63% of all treatment-emergent adverse events (TEAEs), were transient and mostly of mild or moderate intensity and rarely severe (3%). Both active treatments triggered a robust, long-lasting antibody response towards the antigenic peptides used for immunization that optimally cross-reacted with the target epitope on PCSK9. In the AT04A group, a reduction in serum LDLc was observed with a mean peak reduction of 11.2% and 13.3% from baseline compared to placebo at week 20 and 70 respectively, and over the whole study period, the mean LDLc reduction for the AT04A group vs. placebo was −7.2% (95% CI [−10.4 to −3.9], P < 0.0001). In this group, PCSK9 target epitope titers above 50 were associated with clinically relevant LDLc reductions with an individual maximal decrease of 39%. Conclusions Although both AT04A and AT06 were safe and immunogenic, only AT04A demonstrated significant LDLc-lowering activity, justifying further development. Trial registration EudraCT: 2015-001719-11. ClinicalTrials.gov Identifier: NCT02508896.
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Keywords {🔍}

study, ata, pcsk, treatment, ldlc, subjects, article, week, antibody, safety, immunization, pubmed, clinical, google, scholar, group, fig, weeks, response, baseline, placebo, levels, immune, cholesterol, booster, titers, groups, target, cas, analysis, data, antibodies, active, vienna, immunizations, epitope, serum, time, protein, phase, significant, performed, lipid, reduction, medical, full, total, systemic, peptides, cardiovascular,

Topics {✒️}

low single-digit µg/ml low-density lipoprotein cholesterol entire amyloid-β peptide nonparametric kruskal–wallis test contained t-cell epitopes long-lasting antibody response pcsk9-target-epitope-specific pcsk9-mimicking sequences differ assaying pre-immune sera article download pdf pcsk9-specific antibody response patient-friendly therapeutic schedules half-max titer increased immunotherapeutics targeting pcsk9 long-lasting immune response treatment-emergent adverse events periodic physical examinations pcsk9-targeting candidates open access publication indicating strong cross-reactivity high-density lipoprotein required short-term medication long-term ldlc management evelyn berger-sieczkowski entered clinical trials specific active immunotherapy fasting triglycerides ≤ 400 mg/dl specific treatment-induced effects fixed block size early clinical trials privacy choices/manage cookies free pcsk9 concentrations placebo-immunized subjects exhibited open-label study sample size calculation amino acid substitutions full access detect free pcsk9 long-term evaluation european economic area serum ldl cholesterol pcsk9 target epitope high cardiovascular risk long-lasting immunity pcsk9-specific memory full analysis set elimination half-life target protein pcsk9 serum antibody concentration total cholesterol concentrations

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PCSK9 inhibition: the dawn of a new age in cholesterol lowering?

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         description:AT04A and AT06A are two AFFITOPE® peptide vaccine candidates being developed for the treatment of hypercholesterolemia by inducing proprotein convertase subtilisin/kexin type 9 (PCSK9)-specific antibodies. This study aimed to investigate safety, tolerability, antibody development, and reduction of low-density lipoprotein cholesterol (LDLc) following four subcutaneous immunizations. This phase I, single-blind, randomized, placebo-controlled study was conducted in a total of 72 healthy subjects with a mean fasting LDLc level at baseline of 117.1 mg/dL (range 77–196 mg/dL). Each cohort enrolled 24 subjects to receive three priming immunizations at weeks 0, 4, and 8 and to receive a single booster immunization at week 60 of either AT04A, AT06A, or placebo. In addition to safety (primary objective), the antigenic peptide- and PCSK9-specific antibody response and the impact on LDLc were evaluated over a period of 90 weeks. The most common systemic treatment-related adverse events (AEs) reported were fatigue, headache, and myalgia in 75% of subjects in the AT06A group and 58% and 46% of subjects in the placebo and AT04A groups, respectively. Injection site reactions (ISR) representing 63% of all treatment-emergent adverse events (TEAEs), were transient and mostly of mild or moderate intensity and rarely severe (3%). Both active treatments triggered a robust, long-lasting antibody response towards the antigenic peptides used for immunization that optimally cross-reacted with the target epitope on PCSK9. In the AT04A group, a reduction in serum LDLc was observed with a mean peak reduction of 11.2% and 13.3% from baseline compared to placebo at week 20 and 70 respectively, and over the whole study period, the mean LDLc reduction for the AT04A group vs. placebo was −7.2% (95% CI [−10.4 to −3.9], P < 0.0001). In this group, PCSK9 target epitope titers above 50 were associated with clinically relevant LDLc reductions with an individual maximal decrease of 39%. Although both AT04A and AT06 were safe and immunogenic, only AT04A demonstrated significant LDLc-lowering activity, justifying further development. EudraCT: 2015-001719-11. ClinicalTrials.gov Identifier: NCT02508896.
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            PCSK9
            Active immunotherapy
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         PCSK9
         Active immunotherapy
         In vivo antibody development
         LDLc reduction
         First-in-human study
         Pharmacology/Toxicology
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      affiliation:
            name:AFFiRiS AG
            address:
               name:AFFiRiS AG, Vienna, Austria
               type:PostalAddress
            type:Organization
      email:[email protected]
PostalAddress:
      name:Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
      name:Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
      name:Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
      name:Department of Vascular Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands
      name:Laboratoire Inserm, UMR 1188 DéTROI, Université de La Réunion, Sainte Clotilde, France
      name:Department of Neurology, Medical University of Vienna, Vienna, Austria
      name:Department of Medicine I, Medical University of Vienna, Vienna, Austria
      name:Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
      name:Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
      name:AFFiRiS AG, Vienna, Austria
      name:AFFiRiS AG, Vienna, Austria
      name:Origenis GmbH, Martinsried, Germany
      name:SCO:SSiS, Berlin, Germany
      name:Department of Medicine I, Medical University of Vienna, Vienna, Austria
      name:AFFiRiS AG, Vienna, Austria
      name:AFFiRiS AG, Vienna, Austria
      name:AFFiRiS AG, Vienna, Austria
      name:AFFiRiS AG, Vienna, Austria

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