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테라젠이텍스, 경구용 루게릭신약 KDDF 과제 선정 - 바이오스펙테이터

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테라젠이텍스, 경구용 루게릭신약 KDDF 과제 선정

입력 2019-03-14 13:23 수정 2019-03-14 14:29

바이오스펙테이터 장종원 기자

J2H바이오텍과 공동개발..내년 6월까지 신약 후보물질 'TEJ-1704' 초기연구 지원

▲류병환 테라젠이텍스 대표(가운데 왼쪽부터)와 묵현상 KDDF 단장, 김재선 J2H바이오텍 대표가 14일 서울 마포구 KDDF 대회의실에서 'TEJ-1704' 과제 협약식을 가졌다. 테라젠이텍스 제공.

테라젠이텍스와 J2H바이오텍이 개발 중인 경구용 루게릭병(근위축성 측색 경화증) 치료제가 범부처신약개발사업단(KDDF)의 '범부처전주기신약개발사업' 과제에 선정돼 연구비 지원을 받는다.

테라젠이텍스는 14일 서울 마포구 KDDF 대회의실에서 류병환 테라젠이텍스 대표와 김재선 J2H바이오텍 대표, 묵현상 KDDF 단장 등이 참석한 가운데 'TEJ-1704' 과제 협약식을 개최했다고 밝혔다.

테라젠이텍스는 이번 과제 선정으로 KDDF의 연구개발비를 지원받아 오는 2020년 6월까지 J2H바이오텍과 함께 경구용 루게릭병 치료제 'TEJ-1704' 초기연구를 진행할 계획이다. 테라젠이텍스는 이번 과제 연구를 거쳐 내년 하반기에 전임상에 진입할 예정이다.

TEJ-1704은 테라젠이텍스가 J2H바이오텍와 공동개발해 기술도입한 물질로 기존 정맥주사 제형 ALS치료제 라디카바(Radicava, 미쓰비시 다나베 개발)를 경구용으로 바꾼 것이다. 라디카바는 경구 투약 시에는 매우 낮은 생체내 흡수로 인해 약효가 감소되는데 TEJ-1704은 라디카바를 prodrug 형태(약물이 체내 흡수 시 대사에 의해 약효를 갖는 활성대사체로 변환되는 약물)로 개발해 투약 편의성을 개선한다.

회사측은 실험용 랫(Rat)을 이용한 실험을 통해 라디카바를 정맥으로 투여했을 때와 경구로 투여했을 때, 그리고 Prodrug 형태의 물질을 경구로 투여했을 때의 혈중 농도를 각각 측정, 비교했다. 그 결과, 에다라본을 경구로 투여했을 때 경구 절대흡수율이 5%에 불과했으나 Prodrug 형태의 경우, 동일한 몰비(molar ratio)로 정맥투여한 에다라본의 혈중 농도 대비 80%에 달하는 활성성분의 흡수가 이뤄지는 것을 확인했다.

경구용 루게릭병 치료제가 개발되면, 환자들이 정맥주사 치료를 위해 정기적으로 병원을 방문하지 않아도 되며, 휴약기 없이도 약제의 일관된 체내 농도 유지를 기대할 수 있다.

류병환 대표는 "KDDF와 협력해 이번 연구를 성공적으로 수행하고, 신약 개발의 기반을 마련할 것"이라며, "이 치료제는 국내 출시뿐 아니라 글로벌 신약으로 육성할 계획"이라고 말했다.

한편 범부처신약개발사업단은 글로벌 신약 개발을 위해 과학기술정보통신부, 산업통상자원부, 보건복지부가 공동 지원하는 '범부처전주기신약개발사업'을 운영, 글로벌 라이선싱 가능성이 높은 혁신적 신약의 전주기 개발 등을 지원하고 있다.

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