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Coherus anuncia início do estudo Fase 3 do CHS-0214 (Biossimilar Investigativo do Etanercept) em psoríase crônica em placas (RaPsOdy)
Date:7/16/2014

REDWOOD CITY, California, 16 de julho de 2014 /PRNewswire/ -- A Coherus BioSciences, Inc. anunciou o início do seu estudo Fase 3 do CHS-0214, uma proposta de biossimilar do etanercept (Enbrel®) na psoríase crônica em placas (a RaPsOdy). Este anúncio acompanha o recente início de um estudo Fase 3 do CHS-0214 em artrite reumatoide. O estudo psoríase Fase 3 é um estudo mundial de 48 semanas, randomizado, duplo-cego, com controle ativo, de grupos paralelos, multicêntrico em indivíduos com psoríase ativa crônica em placas e não expostos à terapia biológica sistêmica. O estudo procurará demonstrar a biossimilaridade entre o CHS-0214 e o Enbrel® em termos de eficácia, segurança e imunogenicidade. O endpoint primário de eficácia se baseia no percentual de melhoria no Psoriasis Area and Severity Index, PASI (Índice de Área e Severidade da Psoríase) em 12 semanas.

"O início do estudo Fase 3 da RaPsOdy é um passo importante em direção à nossa meta de aumentar o acesso ao etanercept biossimilar para pacientes em todo o mundo", disse Barbara Finck, M.D., diretora médica da Coherus. "Representa um estudo fundamental no desenvolvimento clínico mundial para o CHS-0214 e, em caso positivo, dará apoio às nossas aplicações de marketing na Europa, Estados Unidos e em uma série de outros países."

"Com base em nossa avaliação da similaridade farmacocinética analítica, não clínica e clínica desta molécula, acreditamos que ela atenda aos rigorosos critérios internos para o início do nosso segundo estudo Fase 3 em 2014", disse Denny Lanfear, CEO da Coherus. "Em conjunto com a nossa parceira Baxter<
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SOURCE Coherus BioSciences, Inc.
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