Evidence map›Paper›PMID 34714969›Full record

Trial reportJournal of thrombosis and haemostasis : JTH2022

Pharmacokinetics and pharmacodynamics of Abelacimab (MAA868), a novel dual inhibitor of Factor XI and Factor XIa.

B Alexander Yi, Debra Freedholm, Nancy Widener, Xiaohui Wang, Emilie Simard, Constance Cullen, Naab M Al-Saady, Norman E Lepor, Sara Coulter, Mark Lovern and 1 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of thrombosis and haemostasis : JTH, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 1 pooled it
8.7field-weighted citation impact, top 1% of its field
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

52 citing papers in PubMed, 1 synthesis or guideline pooled it, 94 citations in OpenAlex.

  1. SEOM clinical guidelines on venous thromboembolism (VTE) and cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
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  10. Research and practice in thrombosis and haemostasis · 2026
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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

11 authors at 4 institutions in 2 countries.

B Alexander YiAnthos Therapeutics, Cambridge, Massachusetts, USA.ORCID 0000-0003-4888-2391
Debra FreedholmAnthos Therapeutics, Cambridge, Massachusetts, USA.
Nancy WidenerAnthos Therapeutics, Cambridge, Massachusetts, USA.
Xiaohui WangCertara, Princeton, New Jersey, USA.
Emilie SimardCertara, Princeton, New Jersey, USA.
Constance CullenApollo Biologics, Westlake Village, California, USA.
Naab M Al-SaadyCovance by LabCorp, Maidenhead, UK.
Norman E LeporWestside Medical Associates of Los Angeles, Los Angeles, California, USA.
Sara CoulterAnthos Therapeutics, Cambridge, Massachusetts, USA.
Mark LovernCertara, Princeton, New Jersey, USA.
Dan BloomfieldAnthos Therapeutics, Cambridge, Massachusetts, USA.
Certara (United States) · USCovance (United Kingdom) · GBInstrumental Polymer Technologies (United States) · USWestside Medical Associates of Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFactor XI (FXI) inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of thromboembolic events. Abelacimab (MAA868) is a novel fully human monoclonal antibody that targets the catalytic domain and has dual activity against the inactive zymogen Factor XI and the activated FXI.

objectivesTo investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single dose intravenous and multiple dose subcutaneous administration of abelacimab in healthy volunteers and patients with atrial fibrillation, respectively. PATIENTS/

methodsIn study ANT-003, healthy volunteers were administered single intravenous doses of abelacimab (30-150 mg) or placebo. The ANT-003 study also included a cohort of obese but otherwise healthy subjects. In study ANT-004, patients with atrial fibrillation were administered monthly subcutaneous doses of abelacimab (120 mg and 180 mg), or placebo, for 3 months. Key PK and PD parameters, including activated partial thromboplastin time (aPTT) and free FXI levels, as well as anti-drug antibodies (ADA) were assessed.

resultsFollowing intravenous administration of abelacimab, the terminal elimination half-life ranged from 25 to 30 days. One hour after the start of the intravenous infusion greater than 99% reductions in free FXI levels were observed. Following once monthly subcutaneous administration, marked reductions from baseline in free FXI levels were sustained. Parenteral administration of abelacimab demonstrated a favorable safety profile with no clinically relevant bleeding events.

conclusionsIntravenous and multiple subcutaneous dose administration of abelacimab were safe and well tolerated. The safety, PK, and PD data from these studies support the clinical development of abelacimab.

Indexed as

Antibodies, Monoclonal, HumanizedFactor XIaBlood Coagulation TestsHumansabelacimabAntibodies, Monoclonal, HumanizedFactor XIaMAA868antibodies, monoclonalbloodFactor XIpharmacodynamicspharmacokinetics

Identifiers

PMID34714969
PMCPMC9298689
OpenAlexW3209083413

What OpenQuestion holds

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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.