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부광약품 "당뇨병신약 MLR-1023 후기 2상 종료" - 바이오스펙테이터

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부광약품 "당뇨병신약 MLR-1023 후기 2상 종료"

입력 2018-12-17 10:06 수정 2018-12-17 10:06

바이오스펙테이터 장종원 기자

1년 4개월만 임상 마무리..내년 6월 美 당뇨병학회서 결과 발표

부광약품은 당뇨병신약인 MLR-1023의 후기 2상 임상시험이 종료됐다고 17일 밝혔다.

이번 임상은 총 61개 사이트(미국 40개, 한국 21개)에서 400명의 제2형 당뇨병 환자를 대상으로 진행됐다. 작년 8월에 임상에 돌입했으며 올해 8월 400명 환자 모집 완료, 11월말 투약 완료와 관찰기간을 거쳐 지난 14일 최종 완료됐다.

당뇨병 치료제의 경우, DPP-4 저해제, GLP-1 유사체, SGLT-2 억제제 등 새로운 기전의 치료제들이 시장을 선도하고 있다. MLR-1023은 인슐린 민감도를 증가시키는 린 카이네이즈(Lyn Kinase) 활성제 계열의 첫 번째 물질로 주목받고 있다.

MLR-1023은 전기 2상 임상시험에서 식후혈당 및 공복혈당이 유의미하게 감소시켰고 일부 환자군에선 유의미한 체중감소도 관찰돼 주목을 받았다.

이번 임상의 주요 지표 결과는 이르면 2019년 1월 중에 확인 가능할 전망으로 부광약품은 6월 미국당뇨병학회를 통해 결과를 발표할 예정이다.

부광약품 관계자는 "MLR-1023이 이제 한달 후면 결과를 확인 할 수 있는 단계에 이르렀다"면서 "내년 초 JP모건 헬스케어 컨퍼런스를 시작으로 여러 비지니스 미팅에서 높은 관심을 기대하고 있다"고 말했다.

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