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라파스-보령제약, '도네페질 패치제' 1상 승인 - 바이오스펙테이터

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라파스-보령제약, '도네페질 패치제' 1상 승인

입력 2020-05-27 10:26 수정 2020-05-27 10:28

바이오스펙테이터 봉나은 기자

마이크로니들 통해 약물전달하는 'BR4002', 건강한 성인 18명 대상으로 인하대병원서 진행

라파스와 보령제약이 공동개발하는 알츠하이머형 치매 치료제 '도네패질 패치제'가 국내 임상에 돌입한다.

라파스는 27일 식품의약품안전처로부터 마이크로니들을 통해 알츠하이머형 치매 치료제 도네페질을 전달하는 패치제 'BR4002'의 임상 1상시험계획(IND)을 승인받았다고 밝혔다. 마이크로어레이(마이크로미터 크기의 미세 돌기) 패치제 방식으로 도네페질을 적용하는 첫 임상 사례다.

이 패치제는 보령제약이 마이크로니들 전문회사인 라파스와 공동개발하고 있으며, 이번에 승인받은 IND는 보령제약이 제출했다.

라파스는 피부를 통해 약물을 전달하는 경피전달 패치제를 개발하는 기업으로, 자체 마이크로니들 제조기술 ‘DEN’을 갖춰 이를 다양한 약물에 활용하고 있다. 라파스의 마이크로니들 패치제는 유효성이 있는 약물을 미세한 바늘로 만들어 패치제 형태로 피부에 부착시킴으로써 치료가 이뤄진다.

이번 임상은 도네페질 패치제의 약동학적 특성 및 안전성, 내약성을 비교 평가하기 위해 건강한 성인 지원자 18명을 대상으로 인하대병원에서 수행될 예정이다. 지원자는 어플리케이터를 미적용한 도네페질 패치제 경피부착군, 어플리케이터를 적용한 도네페질 패치제 경피부착군, 대조약 피하주사군으로 무작위로 배정돼 단회투여로 처방받게 된다.

이번 발표를 통해 라파스는 “도네페질 패치제 BR4002는 기존 도네페질 패치제와는 다른 ‘마이크로어레이 경피 흡수제’”라며, “기존 패치제와 달리 분자량이 크고 친수성을 나타내는 약물의 유효성분도 높은 비율로 전달 가능하며, 인핸서(증폭자)로 인해 피부 손상이 없다”고 설명했다.

한편, 라파스는 올해 3월 골다공증 치료를 위한 부갑상선호르몬(PTH) 패치제 ‘RAP18001’의 임상1상도 승인받아 진행하고 있다. 폐경기 이후 여성 환자 15명을 대상으로 PTH 패치제 또는 기존 피하주사제인 ‘테리본’을 적용해 안전성 및 약동학적 특성을 비교하는 임상이다.

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