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대웅제약, ‘펙수프라잔’ 국내 첫 'P-CAB 주사제' "1상 승인" - 바이오스펙테이터

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대웅제약, ‘펙수프라잔’ 국내 첫 'P-CAB 주사제' "1상 승인"

입력 2020-09-15 08:48 수정 2020-09-15 08:48

바이오스펙테이터 김성민 기자

경구 투여가 어려운 환자를 위한 주사제 개발 시작..."국내 임상1상 승인"

대웅제약이 위식도역류질환 치료제 ‘펙수프라잔’의 주사제 개발에 대해 식품의약품안전처로부터 임상1상을 승인받았다고 15일 밝혔다.

대웅제약은 기존 경구제 개발에 이어 주사제로 제형을 추진한다. 주사제는 경구제에 비해 환자 선호도는 낮지만, 경구투여가 어렵거나 신속하게 산분비 억제가 필요한 환자를 위해 개발하게 됐다는 설명이다.

이번 임상1상은 건강한 성인 36명을 대상으로 약물을 정맥투여해 안전성과 내약성, 체내에서 작용하는 특성 등을 평가하게 된다. 펙수프라잔과 위약을 무작위 배정, 이중 눈가림, 위약 대조, 단회 투여하고, 단계적으로 용량을 증량하여 진행된다.

대웅제약은 올해 투약을 시작하고, 내년 중 임상1상 결과를 확보할 것으로 기대한다.

그밖에도 대웅제약은 펙수프라잔 정제의 적응증 추가를 위한 임상시험을 진행하고 있다. 동일 계열 약물 중 유일하게 진행하고 있는 △위염에 대한 임상3상 △미란성 위식도역류질환 치료 후 유지요법에 대한 임상3상 △비스테로이드성 소염진통제(NSAIDs)와 병용시 약물 상호작용에 대한 임상1상 등을 진행하고 있다.

전승호 대웅제약 사장은 “계열 내 최고(Best-in-Class) 혁신 신약으로 개발 중인 펙수프라잔의 제형 다양화로 경구 투여가 어려웠던 환자의 치료에도 도움이 되기를 바란다”며 “대웅제약은 펙수프라잔의 적응증 확대 및 다양한 제형 개발을 통해 펙수프라잔의 제품력을 강화하는데 역량을 집중해 나갈 것”이라고 밝혔다.

한편 대웅제약은 국내 외에도 미국과 중국에서 펙수프라잔의 임상 진입을 준비하고 있다. 지난 8월에는 중남미 최대 시장 브라질 수출계약을 체결하는 등 전 세계로 시장을 확대해 나갈 계획이다.

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