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Replicor divulga a realização de um ano de controle funcional do HBV e HDV com NAPs, além de novas percepções mecânicas em farmacologia com o NAP

Replicor Inc., uma empresa farmacêutica de capital privado, que tem como objetivo uma cura para a infecção crônica por HBV e HDV (hepatites B e D), divulgou hoje novos dados significativos na atividade dos NAPs (neurolépticos de ação prolongada ou antipsicóticos) em infecções por HBV e HDV no encontro anual da Associação Europeia para o Estudo do Fígado (EASL), que ocorre de 19 a 23 de abril de 2017 em Amsterdã, na Holanda.

Atualizações nos estudos REP 301 (coinfecção por HBV/HDV) e REP 401 (infecção por HBV) demonstraram avanços importantes:

1. No estudo REP 301, o controle funcional relatado anteriormente às 24 semanas de acompanhamento do HBV (5/12 pacientes) e HDV (7/12 pacientes) manteve-se por um ano, demonstrando a durabilidade do controle funcional estabelecido com a terapia com base em NAPs (pôster LBP-507).

2. No estudo REP 401, 30 pacientes receberam pelo menos 12 semanas de exposição aos NAPs e a resposta do HBsAg sérico ao longo do tempo continua a melhorar: as reduções atuais de linha de base apresentadas foram de > 1 log em 29 pacientes, > 2 logs em 25 pacientes, > 4 logs em 19 pacientes, com perda de HBsAg em 14 pacientes. A melhoria da eficácia do pegIFN (produção de anti-HBs marcados e/ou exacerbações de transaminase terapêutica) ocorreu em todos os doentes com uma redução de HBsAg> 4 logs (pôster THU-154).

3. Surpreendentemente, a análise do HBsAg, HBeAg, HBcrAg, RNA de HBV, DNA de HBV e RNA de HDV séricos, em ambos os estudos, indicou que o HBsAg circulante parece ser quase completamente derivado da integração.

“A noção de que quase todo o HBsAg circulante é derivado da integração tem importantes implicações terapêuticas”, disse o diretor científico, Dr. Andrew Vaillant. “Como o principal agente imunossupressor nas infecções por HBV e HDV, a remoção do HBsAg será crítica. É muito provável que os novos agentes de investigação com outros mecanismos antivirais ainda exijam agentes que direcionem diretamente a liberação de HBsAg, como os NAPs, para se alcançar uma taxa elevada de controle funcional.” Dr. Bazinet, o diretor executivo, acrescentou: “Nossos dados clínicos continuamente em expansão continuam a demonstrar que taxas significativas de controle funcional do HBV e HDV podem ser alcançadas com os medicamentos atualmente aprovados e os NAPs”.

A sequenciação profunda do HBsAg no estudo REP 102 anterior não demonstrou pressão de seleção com o REP 2139, validando ainda a resposta do HBsAg sérico à terapia com NAP (pôster THU-155). Um sistema de cultura de tecidos recentemente desenvolvido reproduz pela primeira vez os efeitos pós-entrada dos NAPs sobre a secreção de partículas de HBV observadas pré-clinicamente e clinicamente (pôster THU-156).

Dr. Vaillant observou: “A capacidade de se modelar os efeitos pós-entrada dos NAPs em cultura de tecidos é a culminação de mais de 6 anos de trabalho, o que inclui vários colaboradores no mundo inteiro. Com este recurso finalmente disponível, os mecanismos hospedeiros almejados pelos NAPs podem agora começar a ser explorados”.

As apresentações da Replicor no EASL 2017 estão disponíveis agora em www.replicor.com/science/conference-presentations. Para o encontro EASL 2017: https://ilc-congress.eu/.

Sobre a Replicor

Replicor é uma empresa biofarmacêutica de capital privado com os dados mais avançados no desenvolvimento da cura para HBV e HDV. A empresa dedica-se a acelerar o desenvolvimento de um tratamento eficaz para pacientes com infecções por HBV e HBV/HDV. www.replicor.com

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