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美NIH, 릴리 '코로나19 항체' 2/3상 “환자모집 중단” - 바이오스펙테이터

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美NIH, 릴리 '코로나19 항체' 2/3상 “환자모집 중단”

입력 2020-10-28 13:39 수정 2020-10-28 15:04

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'밤라니비맙', 입원환자 대상 ACTIV-3 2/3상서 임상적 이점 부족 판단..비입원환자 대상 ACTIV-2 연구는 지속

미국 국립과학원(NIH)이 병원에 입원한 코로나19 환자를 대상으로 진행한 일라이 릴리(Eli Lilly)의 코로나19 항체 ‘밤라니비맙(bamlanivimab, LY-CoV555)’ 단일요법 임상 2/3상(ACTIV-3 study) 환자 모집을 중단한다.

독립적인 데이터모니터링위원회(Independent data safety monitoring board, DSMB)가 밤라니비맙의 임상데이터를 분석한 결과 임상적 이점이 부족하다고 판단, 지난 13일 환자모집을 일시중단할 것을 권고한 것에 이은 결정이다.

NIH는 지난 26일(현지시간) 코로나19로 입원한 환자를 대상으로 진행하던 ‘LY-CoV555’ 임상 3상의 환자 모집을 중단한다고 밝혔다.

ACTIV-3 연구에서 처음 평가된 약물인 릴리의 코로나19 항체 ‘밤라니비맙’은 326명의 코로나19 입원환자를 대상으로 임상이 진행됐다. DSMB는 치료 5일차에 사전에 정의된 안전성(predefined boundary for safety)에 대한 문제를 이유로 임상을 일시 중지(pause)하고 데이터를 분석에 나섰다. 그 결과, 안전성에는 위약과 차이가 없었지만, 임상적 이점(clinical benefit)을 보이지 못해 환자모집을 중단할 것을 권고했다. 임상에 참여했던 환자들은 90일까지 추적분석할 계획이다. NIH는 상세 데이터를 분석해 향후 발표할 예정이다.

이에 대해 릴리는 임상에 참여한 코로나19 환자들이 더 긴 시간 바이러스에 감염된 상태였고, 밤라니비맙을 적용한 다른 연구보다 환자의 증상이 더 심해 밤라니비맙의 효과가 적었을 것이라고 설명했다.

실제로 릴리는 증상이 심하지 않은 코로나19 환자를 대상으로 진행한 임상에서 밤라니비맙의 효과를 확인한 바 있다. 릴리는 지난 8일 경도에서 중등도 코로나19 환자에 대해 밤라니비맙 단일요법을 미국 식품의약국(FDA)에 긴급사용승인(EUA)을 신청했다. 또, 경도에서 중등도 코로나19 환자에게 ‘밤라니비맙+에테세비맙(etesevimab, LY-CoV016)’ 병용요법 중간분석결과 바이러스 양, 증상, 병원입원, 응급실 방문비율을 감소시킨 긍정적인 결과를 밝힌 바 있다. 병용요법에 대한 EUA는 오는 11월 신청할 예정이다.

NIH는 지난 4월부터 유망한(the most promising) 코로나19 치료제 및 백신 약물들의 개발을 가속화하기 위한 ACTIV(Accelerating COVID-19 Therapeutic Interventions and Vaccines) 이니셔티브를 진행하고 있다. 5가지 프로그램으로 나눠 약물의 효과를 평가중이다.

그 중, ACTIV-3 연구는 코로나19로 입원한 성인을 대상으로 위약과 비교하도록 설계된 임상으로 모든 참가자는 표준치료제인 ‘베클루리(Veklury, remdesivir)’와 함께 약물을 투여받게 된다. 1단계로 약 300명의 환자를 대상으로 안전성과 효과를 확인한 후, 2단계로 700명의 환자를 추가로 모집해 90일간 추적관찰해 약물의 효과를 평가하는 방식이다.

한편, NIH는 릴리의 밤라니비맙을 '비입원' 코로나19 환자에게 적용하는 ACTIV-2 연구를 위한 환자를 계속 모집하고 있다.

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