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Replicor revela el logro del control funcional durante un año del VHB y VHD con NAP y nuevas perspectivas mecanísticas en farmacología NAP

Replicor Inc., una empresa biofarmacéutica de capital privado enfocada en encontrar una cura para los pacientes con infección de hepatitis B y D crónicas, anunció hoy nueva información importante sobre la actividad NAP en infecciones por VHB y VHD en la Jornada Anual de la Asociación Europea para el Estudio del Hígado 2017 (European Association for the Study of the Liver, EASL) que se llevará a cabo entre el 19 y el 23 de abril de 2017 en Ámsterdam, Países Bajos.

Actualizaciones en los estudios con REP 301 (coinfección del VHB/VHD) y con REP 401 (infección del VHB) demostraron importantes avances:

1. En el estudio con REP 301, el control funcional previamente informado en el seguimiento de 24 semanas del VHB (5/12 pacientes) y VHD (7/12 pacientes) demostró que se mantuvo por un año, demostrando así la durabilidad del control funcional establecido en la terapia con NAP (póster LBP-507).

2. En el estudio con REP 401, 30 pacientes fueron expuestos al menos durante 12 semanas al NAP y al AgsHB sérico y la respuesta continúa mejorando con el transcurso del tiempo: las reducciones actuales del nivel basal presentadas fueron >1 reducción de logaritmo en 29 pacientes, >2 reducción de logaritmo en 25 pacientes, >4 reducción de logaritmo en 19 pacientes, con pérdida de AgsHB en 14 pacientes. Hubo una eficacia mejorada del pegIFN (producción marcada de anticuerpos HB y/o erupciones de transaminasa terapéuticas) en todos los pacientes con >4 reducción de logaritmo de AgsHB (póster THU-154).

3. Sorpresivamente, el análisis del AgHBs, AgHBe, AgHBcr, VHB ARN, VHB ADN y VHD ARN en ambos estudios indicó que el AgHBs circulante parece estar casi completamente derivado de la integración.

“La noción de que la mayor parte del AgHBs circulante deriva de la integración tiene consecuencias terapéuticas importantes”, afirmó el director científico Dr. Andrew Vaillant. “Como agente inmunosupresor primario en las infecciones por VHB y VHD, la eliminación del AgHBs será clave. Es muy probable que nuevos agentes investigativos con otros mecanismos antivirales aún requieran agentes directamente destinados a la liberación de AgHBs como NAP a fin de alcanzar un alto nivel de control funcional”. El Dr. Bazinet, director ejecutivo, agregó “nuestros datos clínicos en constante expansión continúan demostrando que se pueden alcanzar elevados niveles de control funcional del VHB y VHD con los fármacos y los NAP actualmente aprobados”.

El secuenciamiento del AgHBs en el estudio previo con REP 102 demostró que no hubo presión de selección con REP 2139, lo que validó aún más la respuesta sérica del AgHBs a la terapia NAP (Póster THU-155). Un sistema de cultivo de tejidos recientemente desarrollado reproduce ahora por primera vez los efectos posteriores al ingreso de NAP en la secreción de partículas del VHB observadas preclínicamente y clínicamente (Póster THU-156).

El Dr. Vaillant destacó, “La capacidad de modelar los efectos posteriores al ingreso de NAP en el cultivo de tejidos es la culminación de más de 6 años de trabajo que incluyen a varios colaboradores de todo el mundo. Con esta herramienta finalmente implementada, los mecanismos anfitriones seleccionados por NAP ahora pueden comenzar a ser explorados”.

Las presentaciones de Replicor realizadas en EASL 2017 están ahora disponibles en www.replicor.com/science/conference-presentations. Para la Jornada EASL 2017: https://ilc-congress.eu/.

Acerca de Replicor

Replicor es una compañía biofarmaceútica de propiedad privada con los datos clínicos más avanzados en el desarrollo de la cura del VHB y del VHD. La compañía se dedica a acelerar el desarrollo de un tratamiento efectivo para los pacientes con infección por VHB y VHB/VHD. www.replicor.com

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