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Drug Development.

Aaron B Kantor1, Tanja A M Hoffman1, Dana Mannick2

  • 1Therini Bio, Sacramento, CA, USA.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 25, 2025
PubMed
Summary
This summary is machine-generated.

THN391, a novel antibody targeting fibrin-induced inflammation, demonstrated safety and tolerability in a Phase 1a study. Its long half-life supports monthly intravenous dosing for neurodegenerative diseases.

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Area of Science:

  • Neuroscience
  • Immunology
  • Pharmacology

Background:

  • Current Alzheimer's disease (AD) treatments do not address inflammation, a key disease driver, and carry safety risks, particularly for ApoE4 homozygotes.
  • THN391 is a novel monoclonal antibody targeting a specific inflammatory epitope on fibrin, a protein involved in blood coagulation.
  • This epitope is exposed at sites of vascular damage and triggers inflammatory responses mediated by microglia and other immune cells.

Purpose of the Study:

  • To evaluate the safety, tolerability, and pharmacokinetics (PK) of THN391 in healthy subjects.
  • To assess the impact of THN391 on coagulation and fibrinolysis.
  • To determine the appropriate dosing regimen for future clinical trials.

Main Methods:

  • A randomized, double-blind, placebo-controlled Phase 1a trial involving single and multiple ascending doses (SAD and MAD) in healthy volunteers.
  • Doses ranged from 0.3 to 40.0 mg/kg, with varying administration frequencies (Q2W and Q4W).
  • Safety assessments included rotational thromboelastometry (ROTEM) to monitor coagulation and fibrinolysis.

Main Results:

  • THN391 was found to be safe and well-tolerated across all tested doses, with only mild, infusion-site related adverse events.
  • No clinically significant changes in laboratory results, vital signs, or ECGs were observed.
  • THN391 did not impact coagulation or fibrinolysis, and PK modeling indicated dose proportionality with a terminal half-life of 38 days.

Conclusions:

  • THN391 is a safe and well-tolerated first-in-class antibody targeting fibrin-induced inflammation, supporting monthly IV dosing.
  • A Phase 1b study in early AD patients with confirmed cerebral small vessel disease (cSVD) is planned, including ApoE4 homozygotes.
  • The upcoming study will assess safety, PK, and preliminary efficacy using biomarkers, MRI, and cognitive assessments.