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Eiger Bio anuncia resultados provisórios do lonafarnibe em combinação com ritonavir ou interferon peguilado em pacientes infectados com o vírus da hepatite delta (HDV)
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- Resultados apresentados durante a conferência da Associação Europeia para o Estudo do Fígado (EASL - European Association for the Study of the Liver) em Viena, Áustria


News provided by

Eiger BioPharmaceuticals, Inc.

Apr 27, 2015, 03:05 ET

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PALO ALTO, Califórnia, 27 de abril de 2015 /PRNewswire/ -- A Eiger BioPharmaceuticals, Incorporated anunciou hoje a apresentação dos resultados provisórios dos dados da Fase 2 do lonafarnibe em pacientes com infecção crônica por hepatite delta viral (HDV). Os dados foram apresentados a partir do programa LOWR HDV, registrado na Escola Médica da Universidade de Ankara, na Turquia, em um país onde a HDV é endêmica.

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LOWR HDV – 1 (LOnafarnib With and without Ritonavir-1 - Lonafarnibe com ou sem Ritonavir -1) é um estudo de comparação de doses paralelas no qual os sujeitos recebem diferentes doses de lonafarnibe com ou sem ritonavir ou interferon peguilado por quatro até doze semanas. Dados provisórios de 15 sujeitos que receberam lonafarnibe puro ou com o reforço do ritonavir ou em combinação com interferon peguilado todos mostraram declínio nas cargas virais. Altas doses (200 mg duas vezes ao dia ou 300 mg duas vezes ao dia) de lonafarnibe resultaram em declínio de 1,6 e 2,0 log nas cargas virais depois de quatro semanas de tratamento respectivamente. Uma dose mais baixa de lonafarnibe (100 mg duas vezes ao dia) com 100 mg diárias de reforço do ritonavir ou em combinação com 180 mcg uma vez por semana de interferon peguilado resultaram em declínio de 2,2 e de 1,8 log na carga viral na semana 4, respectivamente. Na semana 8, os declínios médios da carga viral foram de 3,2 e 3,0 log para sujeitos que receberam lonafarnibe com ritonavir ou lonafarnibe com interferon peguilado, respectivamente.

Os efeitos colaterais mais frequentemente observados no LOWR-1 foram anorexia, náusea, diarreia, fadiga e perda de peso e pareciam depender da dosagem.

LOWR HDV - 2 (LOnafarnib With Ritonavir-2 - Lonafarnibe com Ritonavir-2) foi iniciado recentemente para testar uma série de doses do lonafarnibe reforçado pelo ritonavir, com o objetivo de identificar as combinações ideais para os próximos estudos de longo prazo.

"Os dados gerados até agora na investigação das combinações do lonafarnibe são muito encorajadores", disse Cihan Yurdaydin, MD, Investigador Principal da Escola de Medicina da Universidade de Ankara. "Continuamos a conduzir estudos para determinação das doses do lonafarnibe reforçado pelo ritonavir para identificar o equilíbrio ideal entre eficácia e tolerância, com o objetivo de eliminação viral".

Sobre o Lonafarnibe
O lonafarnibe é um inibidor bem caracterizado, de última fase, oralmente ativo de farnesil transferase, uma enzima envolvida na modificação das proteínas por meio de um processo chamado prenilação. O vírus HDV usa esse processo de célula hospedeira dentro de células do fígado para completar um passo fundamental para o seu ciclo de vida. O lonafarnibe inibe a etapa da prenilação de replicação do vírus HDV dentro das células hepáticas e bloqueia o ciclo de vida do vírus em seu estágio de formação. Uma vez que a prenilação é um processo realizado por enzima hospedeira, há também uma maior barreira teórica para desenvolver mutações na resistência viral à terapia com lonafarnibe.

O lonafarnibe recebeu Designação de Medicamento Órfão pela Agência de Alimentos e Medicamentos (FDA) dos Estados Unidos e da Agência Europeia de Medicamentos (EMA) e designação de Tramitação Rápida (Fast Track) da FDA dos Estados Unidos. O lonafarnibe é um produto em fase de pesquisa e sua segurança e eficácia ainda não foram estabelecidas para qualquer indicação. O lonafarnibe é licenciado pela Merck Sharp & Dohme Corp. (conhecida como MSD fora dos Estados Unidos e do Canadá).

Sobre a HDV
A hepatite delta é causada pela infecção com o vírus da hepatite D (HDV) e é considerada a forma mais grave de hepatite viral em seres humanos. A hepatite D ocorre apenas como uma coinfecção em pessoas com hepatite B (HBV). A hepatite D conduz à doença hepática mais grave do que o HBV por si só e está associada com fibrose acelerada do fígado, câncer de fígado e insuficiência hepática. A HDV é uma doença com um impacto significativo na saúde global que afeta cerca de 15 milhões de pessoas em todo o mundo. A prevalência do HDV varia entre as diferentes partes do mundo. Globalmente, a infecção HDV está presente em cerca de 5% a 6% de portadores de hepatite B crônica. Em algumas partes do mundo, inclusive algumas áreas da China, Mongólia, Rússia, Ásia Central, Turquia, África e América do Sul, a prevalência da HDV de até 70% tem sido relatada em pacientes infectados pelo HBV.

Sobre a Eiger
A Eiger é uma companhia privada de biotecnologia, concentrada na pesquisa, desenvolvimento e comercialização de terapias inovadoras para hepatite viral. A companhia se concentra no desenvolvimento do lonafarnibe para o tratamento do vírus da hepatite delta (HDV), a forma mais grave de hepatite viral. Para mais informações sobre a Eiger e seu programa de pesquisa e desenvolvimento, visite o endereço www.eigerbio.com.

Investidores: Jim Shaffer, Eiger BioPharmaceuticals, Inc., +1-919-345-4256, [email protected] 

FONTE Eiger BioPharmaceuticals, Inc.

Related Links

http://www.eigerbio.com

SOURCE Eiger BioPharmaceuticals, Inc.

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