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Desarrollo de Fármacos

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
Resumen
Este resumen es generado por máquina.

THN391, un novedoso anticuerpo dirigido a la inflamación inducida por fibrina, demostró seguridad y tolerabilidad en un estudio de Fase 1a. Su larga vida media respalda la dosificación intravenosa mensual para enfermedades neurodegenerativas.

Palabras clave:
Enfermedad de AlzheimerNeurocienciaInmunologíaFarmacologíaDesarrollo de FármacosInflamaciónFibrinaAnticuerpos MonoclonalesFarmacocinéticaSeguridadTolerabilidad

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Área de la Ciencia:

  • Neurociencia; Inmunología; Farmacología

Sus antecedentes:

  • Los tratamientos actuales para la enfermedad de Alzheimer (EA) no abordan la inflamación, un motor clave de la enfermedad, y conllevan riesgos de seguridad, especialmente para los homocigotos ApoE4.
  • THN391 es un anticuerpo monoclonal novedoso dirigido a un epítopo inflamatorio específico en la fibrina, una proteína involucrada en la coagulación sanguínea.
  • Este epítopo se expone en sitios de daño vascular y desencadena respuestas inflamatorias mediadas por microglía y otras células inmunes.

Objetivo del estudio:

  • Evaluar la seguridad, tolerabilidad y farmacocinética (PK) de THN391 en sujetos sanos.
  • Evaluar el impacto de THN391 en la coagulación y la fibrinólisis.
  • Determinar el régimen de dosificación apropiado para futuros ensayos clínicos.

Principales métodos:

  • Un ensayo de Fase 1a aleatorizado, doble ciego, controlado con placebo, que involucra dosis únicas y ascendentes múltiples (SAD y MAD) en voluntarios sanos.
  • Las dosis variaron de 0.3 a 40.0 mg/kg, con diferentes frecuencias de administración (Q2W y Q4W).
  • Las evaluaciones de seguridad incluyeron la tromboelastometría rotacional (ROTEM) para monitorear la coagulación y la fibrinólisis.

Principales resultados:

  • THN391 se consideró seguro y bien tolerado en todas las dosis probadas, con solo eventos adversos leves relacionados con el sitio de infusión.
  • No se observaron cambios clínicamente significativos en los resultados de laboratorio, signos vitales o ECG.
  • THN391 no afectó la coagulación ni la fibrinólisis, y el modelado PK indicó proporcionalidad a la dosis con una vida media terminal de 38 días.

Conclusiones:

  • THN391 es un anticuerpo de primera clase, seguro y bien tolerado, dirigido a la inflamación inducida por fibrina, que respalda la dosificación IV mensual.
  • Se planea un estudio de Fase 1b en pacientes con EA temprana con enfermedad de pequeños vasos cerebrales (EPVC) confirmada, incluidos homocigotos ApoE4.
  • El próximo estudio evaluará la seguridad, PK y la eficacia preliminar utilizando biomarcadores, RM y evaluaciones cognitivas.