Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'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 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'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 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'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 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'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 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'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 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'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 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'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 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'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 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'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 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'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 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'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 'biosssh118'@'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, '한미 당뇨신약' 글로벌 3상 추가..총 5개 진행 - 바이오스펙테이터

본문 바로가기

바이오스펙테이터

기사본문

사노피, '한미 당뇨신약' 글로벌 3상 추가..총 5개 진행

입력 2018-12-14 08:28 수정 2018-12-14 08:57

바이오스펙테이터 장종원 기자

美 임상정보 사이트에 2개 3상 과제 등록..경쟁약물 비교 및 단독·병용요법 등 연구..모든 임상 2021년 상반기 종료 예정

한미약품이 사노피에 기술이전한 당뇨 바이오신약 '에페글레나타이드’의 글로벌 3상 과제 2개가 추가 진행된다. 이에 따라 사노피가 당초 계획했던 이 약물의 글로벌 3상 과제 5개 모두가 착수돼 미국 등 지역에서 동시다발적으로 빠르게 연구가 진행될 예정이다.

14일 한미약품과 미국 국립보건원이 운영하는 임상정보사이트(clinicaltrials.gov) 등에 따르면 한미약품 파트너사인 사노피는 최근 에페글레나타이드의 신규 글로벌 3상 과제 2건을 등록했다.

사노피는 지금까지 위약과의 비교 임상, 심혈관 위험 검증을 위한 임상, 경쟁약물(트루리시티)과의 비교 임상 등 글로벌 3상 3개를 진행해왔다.

이번에 사노피가 추가 진행한다고 공개한 2개 임상 중 하나는 메트포르민(광범위 경구용 당뇨약) 단독 또는 설포닐우레아(경구용당뇨약)를 함께 복용하고 있지만 혈당이 충분하게 조절되지 않는 제2형 당뇨환자 640명을 대상으로 에페글레나타이드 용량별 투여와 위약을 비교 평가하는 연구다. 약물을 주 1회씩 30주간 투여하면서 약물 안전성과 혈당조절 및 체중조절 효과 등을 비교하는 방식이다.

또 다른 추가 임상은 기저인슐린을 단독 투여하고 있거나 경구용 당뇨약도 함께 복용하고 있지만 충분한 혈당 조절이 되지 않는 제2형 당뇨환자 400명을 대상으로 에페글레나타이드 용량별 투여와 위약을 비교 평가하는 연구다. 에페글레나타이드와 위약을 주 1회씩 56주간 투여하면서 약물 안전성, 혈당조절 및 체중조절 효과 등을 비교하게 된다.

이들 추가 임상 2건을 포함한 총 5건의 에페글레나타이드 글로벌 임상 3상에 참여하게 될 환자는 6400여명에 이르며, 사노피는 이 모든 임상 과제들을 2021년 상반기 중 마무리할 계획이다.

권세창 한미약품 대표이사는 “에페글레나타이드의 빠른 상용화와 신약 가치 제고를 위한 동시다발적 글로벌 임상 3상이 순조롭게 진행되고 있다”며 “질병으로 고통받는 환자들의 삶의 질을 획기적으로 개선할 수 있도록 파트너사와 긴밀히 협력하며 최선을 다하겠다”고 말했다.

에페글레나타이드는 바이오신약 약효 주기를 늘려주는 한미약품의 플랫폼 기술 ‘랩스커버리’가 적용된 지속형 GLP-1 계열 당뇨 치료제로 2015년 사노피에 기술이전됐다.

카카오스토리로 기사 공유하기