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348 Warning: mysql_real_escape_string(): Access denied for user 'et1ssh96'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30 Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30 Warning: mysql_query(): Access denied for user 'et1ssh96'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 530 Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 530 Warning: mysql_fetch_array() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 531 길리어드-갈라파고스, 류마티스 대상 "필고티닙 3상 성공" - 바이오스펙테이터

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길리어드-갈라파고스, 류마티스 대상 "필고티닙 3상 성공"

입력 2018-09-13 13:38 수정 2018-09-13 13:38

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생물학적 항류마티스 요법 불응하는 류마티스관절염 임상 3상 FINCH 2 결과 1차 및 2차 종결점 충족

길리어드(Gilead Sciences)와 갈라파고스(Galapagos NV)는 류마티스 관절염 치료제로 개발중인 '필고티닙(Filgotinib)'의 임상 3상을 성공적으로 마쳤다.

양사는 류마티스 관절염 치료제로 선택적 JAK1 억제제 필고티닙을 이용한 글로벌 임상 3상(FINCH 2)에서 1차 종결점 및 모든 주요한 2차 종결점을 충족했다고 지난 11일 발표했다.

FINCH 2 임상시험은 생물학적 항류마티스 요법(bDMARD)에 적절한 반응을 보이지 않은 중등도(Moderate)에서 중증(Severe) 활성 류마티스 관절염 환자 449명이 필고티닙(100mg 또는 200mg)이나 위약을 1일 1회 12주, 24주간 복용한 결과를 관찰했다.

필고티닙을 복용한 환자는 1차 종결점으로 ‘약물 복용 후 12주차에 관절염 증상이 20% 이상 개선됐음’을 뜻하는 ACR 20(American College of Rheumatology 20)을 충족했다. 2차 종결점으로 약물 복용 후 12주와 24주차에 ACR50, ACR70, 낮은 질병 활성도(Low Disease Activity, LDA) 및 임상적 관해(Clinical Remission)를 충족하는 환자 비율도 위약을 복용한 환자와 비교해 필고티닙을 복용한 환자에게서 유의미하게 높았다.

중대한 이상 반응(Serious Adverse Event, SAE) 발생률은 위약, 필고티닙 100mg, 필고티닙 200mg을 복용한 환자에서 각각 3.4%, 5.2%, 4.1%로 나타났다.

길리어드의 수석 연구 책임자 존 매허친슨(John McHutchison) 박사는 “첫번째 임상 3상 FINCH 2 결과를 통해, 현재 류마티스 관절염 환자를 대상으로 진행 중인 임상 3상 FINCH 1과 FINCH 3의 긍정적 결과를 기대하게 됐다”고 밝혔다.

길리어드는 추후 학회에서 자세한 FINCH 2 결과를 발표할 예정이다.

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