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리제네론·릿지백, 4개 에볼라치료제 비교임상 ‘조기종료’ - 바이오스펙테이터

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리제네론·릿지백, 4개 에볼라치료제 비교임상 ‘조기종료’

입력 2019-08-13 15:40 수정 2019-08-13 19:31

바이오스펙테이터 봉나은 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
리제네론의 ‘REGN-EB3’, 릿지백의 ‘mAb114’가 에볼라 감염병 표준치료제인 ‘지맵’ 대비 생존 가능성 높인 결과로 독립적인 데이터 및 안전성 모니터링 위원회(DSMB)가 임상 조기종료 권고

리제네론 파마슈티컬스(Regeneron Pharmaceuticals)와 릿지백 바이오테라퓨틱스(Ridgeback Biotherapeutics)는 12일(현지시간) 에볼라 바이러스 감염에 대한 4개 치료제를 비교하는 PALM 임상2/3상(NCT03719586)의 조기 종료 소식을 알렸다.

독립적인 데이터 및 안전성 모니터링 위원회(Independent data and safety monitoring board, DSMB)가 에볼라 바이러스 감염병에 걸린 환자 499명 대상의 임상 중간결과를 검토한 결과로, 임상의 조기 종료를 권고한 데 따른 것이다. 임상 중간결과에서 리제네론의 ‘REGN-EB3’와 릿지백의 ‘mAb114’는 에볼라 바이러스 감염병의 표준 치료제인 맵 바이오파마슈티컬(Mapp Biopharmaceutical)의 ‘지맵(ZMapp)’보다 생존 가능성을 유의미하게 높인 것으로 확인됐다.

임상에서는 에볼라 바이러스 감염병 치료제로 리제네론의 ‘REGN-EB3’, 릿지백의 ‘mAb114’, 맵의 ‘지맵’, 길리어드의 ‘렘데시비르(Remdesivir, 프로그램명: GS-5734)’를 비교 평가했다.

임상은 지난해 11월 콩고 민주공화국에서 개시된 이후, 지난 9일까지 목표 환자 725명 중 681명이 등록됐다. 임상에 등록된 환자에게 REGN-EB3는 2시간동안 정맥투여되며, 1회 처방됐다. mAb114는 30~60분동안 정맥투여되며, 1회 처방됐다. 반면, 지맵은 4시간동안 정맥투여되며, 3일 간격으로 3회 처방되고, 렘데시비르는 1시간동안 정맥투여되며, 1일 1회씩 10일동안 처방됐다....

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