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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 SK바이오팜, 뇌전증신약 ‘세노바메이트’의 4가지 강점 - 바이오스펙테이터

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SK바이오팜, 뇌전증신약 ‘세노바메이트’의 4가지 강점

입력 2018-05-30 14:20 수정 2018-06-01 07:12

바이오스펙테이터 이은아 기자

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올해말 NDA 신청계획.."발작빈도 감소율 50%↑, 적용가능한 넓은 스펙트럼, 1일1회 약물, 안전성 입증, 적응증 확대 가능성도.."

‘한 우물만 파면 성공한다’는 얘기가 신약개발에도 통할까? 자체개발한 뇌전증 치료제로 직접 글로벌 임상 3상까지 추진해 올해 말 미국 FDA 신약승인신청(NDA)를 앞두고 있는 SK바이오팜의 이야기다. SK바이오팜은 SK그룹의 지주회사인 SK주식회사의 자회사로 지난 1993년부터 25여년동안 중추신경계 질환 분야에 집중한 신약개발을 해왔다.

SK바이오팜은 현재 미국 재즈파마슈티컬스(Jazz Pharmaceuticals)에 기술이전한 수면장애신약 후보물질 ‘SKL-N05'의 NDA에 대한 FDA 심사를 받고 있으며, 뇌전증 치료제 ’세노바메이트(Cenobamate)‘는 기술수출 없이도 독자적으로 진행한 글로벌 임상3상의 막바지 단계에 있다. 특히 세노바메이트는 2016년 뇌전증 신약 후보물질 가운데 세계 최초로 FDA로부터 임상3상에서 안전성만 추가로 입증하면 NDA 제출이 가능하다고 확인받아 업계의 주목을 받았다.

▲박정신 SK바이오팜 임상개발실장

박정신 SK바이오팜 임상개발실장은 지난 29일 판교 혁신신약살롱에서 뇌전증 치료제 ‘세노바메이트(Cenobamate)’의 임상결과에 대해 직접 소개했다.

세노바메이트는 현재 전세계 17개국의 125사이트에서 환자 1200명을 대상으로 임상3상 시험을 진행 중이다. 주목할 부분은 유효성을 확인하는 임상3상이 아닌 안전성과 약물동력학을 평가하는 오픈라벨 시험이라는 점이다. 지난 2016년 FDA가 세노바메이트의 임상2상 효능 결과를 인정해 추가적인 안전성만 확인되면 NDA 신청이 가능하다고 인정한 것.

박 실장은 “세노바메이트가 보인 임상2상 효능(efficacy) 결과 덕분에 신약개발에 속도를 낼 수 있었다. 현재 글로벌 임상3상의 막바지 단계로 올해 말 NDA 제출할 예정이다”고 강조했다.

뇌전증(Epilepsy)은 신체적 이상이 없음에도 불구하고 신경세포 이상에 의한 발작(Seizure)이 반복적으로 발생하는 질환이다. 알 수 없는 이유로 신경세포가 과도하게 흥분되면서 뇌의 특정 부분을 통제하지 못하는 증상을 보인다. 일반적으로 전세계 인구의 5%가 인생에서 한번쯤 발작을 경험한다고 한다. 이러한 발작증상은 과도한 신경흥분이 ...

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