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JW중외 기술이전 아토피신약, 임상1상 韓→美로 확장 - 바이오스펙테이터

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JW중외 기술이전 아토피신약, 임상1상 韓→美로 확장

입력 2019-08-27 10:27 수정 2019-08-27 10:49

바이오스펙테이터 조정민 기자

레오파마, ‘JW1601’ 국내 임상1상 결과 바탕으로 추가적 약동학 특성 분석 위해 美 FDA 임상 신청

JW중외제약이 지난해 덴마크 레오파마로 기술이전한 아토피 피부염 치료제 ‘JW1601(레오파마 프로젝트명 LP0190)’가 한국에 이어 미국 임상 진입을 시도한다.

JW중외제약은 27일, 레오파마가 JW1601의 약동학 분석을 위한 임상시험계획(IND)을 미국 식품의약국(FDA)에 신청했다고 밝혔다.

JW1601은 히스타민(histamine) H4수용체에 선택적으로 작용해 아토피 피부염을 유발하는 면역세포의 활성과 이동을 차단하고 가려움증을 일으키는 히스타민의 신호전달을 억제하는 이중 작용기전을 가진 신약 후보물질이다.

JW중외제약은 올 1월부터 건강한 성인을 대상으로 JW1601 단회투여 및 반복투여 형태의 임상 1상을 진행하고 있으며 최근 단회투여 임상시험을 종료했다. 임상 결과 최대 내약 용량을 결정하는 ‘용량 증량 코호트 연구’에서 안전성과 내약성을 확인한 것으로 알려졌다.

기술이전 이후 JW중외제약과 지속적으로 협력해온 레오파마는 JW중외제약이 국내에서 수행한 임상1상 데이터를 토대로 건강한 성인 대상 경구 투여 시 약동학적 특성을 추가로 분석하기 위해 임상을 진행한다.

레오파마 글로벌 R&D 책임자인 퀄러(Kioeller)박사는 “JW중외제약과의 협력을 통해 개발 중인 경구용 아토피 피부염 치료제 임상이 다음 단계로 진척돼 기쁘게 생각한다”며 “JW1601이 아토피 피부염 환자들의 삶의 질에 실질적으로 영향을 줄 것”이라고 말했다.

이성열 JW중외제약 개발본부장은 “한국인 대상 단회투여 시험이 순조롭게 마무리돼 레오파마가 신속하게 이번 임상시험계획을 신청할 수 있게 됐다. 앞으로도 레오파마와 파트너십을 강화해 글로벌 시장에서 중추적 역할을 할 아토피 피부염 신약으로 개발해 나가겠다”고 말했다.

JW중외제약은 2018년 8월 전임상 단계의 JW1601을 레오파마에 4500억원 규모로 기술이전했다.

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