Evidence map›Paper›PMID 32613752›Full record

Trial reportCPT: pharmacometrics & systems pharmacology2020

Phase II Dose Selection for Alpha Synuclein-Targeting Antibody Cinpanemab (BIIB054) Based on Target Protein Binding Levels in the Brain.

Mita Kuchimanchi, Michael Monine, Kumar Kandadi Muralidharan, Caroline Woodward, Natalia Penner

Abstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in CPT: pharmacometrics & systems pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed.

  1. A Randomized First-in-Human Study With UB-312, a UBITh® α-Synuclein Peptide Vaccine.Movement disorders : official journal of the Movement Disorder Society · 2022
    Trial
  2. Article
  3. Review
  4. Progress of Immunotherapies in Parkinson's Disease.CNS neuroscience & therapeutics · 2026
    Review
  5. Organosulfur Compounds: Potential Therapeutics for Parkinson's Disease.CNS & neurological disorders drug targets · 2026
    Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Article
  20. Monoclonal Antibodies as Neurological Therapeutics.Pharmaceuticals (Basel, Switzerland) · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Mita KuchimanchiClinical Pharmacology & Pharmacometrics, Biogen Inc., Cambridge, Massachusetts, USA.
Michael MonineClinical Pharmacology & Pharmacometrics, Biogen Inc., Cambridge, Massachusetts, USA.
Kumar Kandadi MuralidharanClinical Pharmacology & Pharmacometrics, Biogen Inc., Cambridge, Massachusetts, USA.
Caroline WoodwardClinical Pharmacology & Pharmacometrics, Biogen Inc., Cambridge, Massachusetts, USA.
Natalia PennerClinical Pharmacology & Pharmacometrics, Biogen Inc., Cambridge, Massachusetts, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This modeling and simulation analysis was aimed at selecting doses of cinpanemab (BIIB054), a monoclonal antibody targeting aggregated α-synuclein, for a phase II study in Parkinson's disease (PD). Doses and regimens were proposed based on anticipated target concentration in brain interstitial fluid (ISF); in vitro/in vivo data on the affinity of monoclonal antibodies to the target protein; and safety, tolerability, and pharmacokinetic data (1-135 mg/kg intravenous administration) from a phase I single ascending dose (SAD) study. A population pharmacokinetic modeling approach was used to select intravenous doses of 250, 1,250, and 3,500 mg every 4 weeks, to maintain 50%, 90%, and > 90% of target binding in ISF of PD participants. A favorable safety profile from the SAD study-which showed that cinpanemab was generally well-tolerated at doses up to 90 mg/kg, supported by modeling and simulations of the anticipated safety margins-allowed implementation of a fixed-dose approach.

Indexed as

Administration, IntravenousAdultAgedalpha-SynucleinAntibodies, MonoclonalBrainComputer SimulationDose-Response Relationship, ImmunologicDrug DevelopmentDrug ToleranceExtracellular FluidFemaleHumansMaleMiddle AgedParkinson Diseasealpha-SynucleinAntibodies, Monoclonal

Identifiers

PMID32613752
PMCPMC7499191

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.