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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 사노피-리제네론, 축농증 대상 '듀피젠트' 3상 성공 - 바이오스펙테이터

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사노피-리제네론, 축농증 대상 '듀피젠트' 3상 성공

입력 2018-10-18 15:34 수정 2018-10-18 17:00

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비용종이 있는 축농증 환자에게 듀피젠트 적용한 2개의 임상 3상에서 1차 및 2차 종결점 충족

사노피(Sanofi)와 리제네론(Regeneron)은 ‘비용종이 있는 축농증(만성 비부비동염)’(Chronic rhinosinusitis with nasal polyps, CRSwNP) 환자를 대상으로 한 듀피젠트(Dupixent, 성분명: Dupilumab) 임상 3상에서 1차 및 2차 종결점을 모두 충족하는 긍정적인 결과를 얻었다고 지난 16일 발표했다.

사노피와 리제네론이 공동 개발한 듀피젠트는 사이토카인 IL-4와 IL-13의 신호전달을 억제하도록 고안된 인간화 단일클론항체로 지난해 3월, 중등도 및 중증 아토피 피부염 성인 환자의 치료제로 FDA로부터 승인을 받았다.

이번에 발표한 CRSwNP 환자 276명, 448명 대상으로 진행한 임상(SINUS-24, SINUS-52)은 약물 투여 24주차에 동일한 1차 종결점으로 평가했다. ‘듀피젠트’와 표준요법인 ‘코르티코스테로이드(corticosteroid) 나잘 스프레이(nasal spray)’를 처방받은 환자의 코막힘/비폐색(nasal congestion/obstruction) 심각도는 각 임상별로 51%, 57% 개선된 반면, ‘나잘 스프레이’를 단일 처방받은 환자는 15%, 19% 향상된 것을 확인했다.

또한 듀피젠트를 처방받은 환자의 비용종 점수는 각각 27%, 33% 낮아져 비용종 크기가 작아진 것을 확인한 반면, 위약을 처방받은 환자의 비용종 점수는 4%, 7% 올라 위약 처방 이전보다 비용종의 크기가 커졌다는 것을 확인했다.

듀피젠트는 두 임상의 2차 종결점도 모두 충족했다. 듀피젠트를 처방받은 환자에게서 전신성 코르티코스테로이드(systemic corticosteroids)나 수술의 필요성이 유의미하게 감소하는 것을 관찰했고, 후각 기능과 축농증 증상이 개선되는 것을 확인했다. 더불어 듀피젠트는 천식을 동반하는 환자군에게서 폐 기능과 천식 조절에 유의미한 향상도 보였다.

양사는 임상의 자세한 결과를 향후 의학 컨퍼런스에서 발표할 예정이며, 자료의 일부는 승인 신청서에 포함될 것이라고 밝혔다.

사노피와 리제네론은 듀피젠트를 이용해 다양한 질환을 대상으로 임상을 진행하고 있다. 현재 ‘천식을 포함한 알레르기나 2형 염증’(under regulatory review), 소아 천식(임상 3상), 소아 아토피 피부염(임상 3상), 청소년 아토피 피부염(임상 3상), 호산성 식도염(임상 3상), 잔디 알레르기(임상 2상), 땅콩 알레르기(임상 2상)를 대상으로 하며, 추후 만성 폐쇄성 폐질환(Chronic Obstructive Pulmonary Disease, COPD)에 대한 임상도 계획하고 있다.

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