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대웅제약 "PRS저해 폐섬유증 신약 호주 1상 승인" - 바이오스펙테이터

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대웅제약 "PRS저해 폐섬유증 신약 호주 1상 승인"

입력 2019-08-22 11:37 수정 2019-08-22 11:37

바이오스펙테이터 조정민 기자

폐섬유증 치료제 ‘DWN12088’ 오는 9월 글로벌 임상 본격 착수… 美 희귀의약품 지정으로 향후 신속심사·독점권 혜택 받아

▲대웅제약 외관

대웅제약이 개발 중인 폐섬유증 신약 ‘DWN12088’이 호주에서 임상 1상에 돌입한다.

대웅제약은 21일 호주 식품의약청(Therapeutic Goods Administration; TGA)로부터 건강한 사람에게서 DWN12088의 안전성과 내약성 등을 확인하기 위한 목적의 현지 임상 1상을 승인받았다고 밝혔다. 이에 회사 측은 9월부터 본격적인 임상시험에 돌입할 예정이다.

특발성폐섬유증은 폐가 서서히 굳어지면서 폐 기능을 상실하게 되는 간질성 폐질환 중 하나로, 치료가 어렵고 진단 후 5년 생존율이 40% 미만인 희귀질환이다.

DWN12088은 콜라겐 주요 구성물질인 프롤린(Proline) 합성효소인 PRS(Prolyl-tRNA Synthetase) 단백질 활성만을 선택적으로 감소시켜 폐섬유증의 원인이 되는 콜라겐의 과도한 생성을 억제하는 경구용 섬유증 치료제다.

대웅제약은 폐섬유증 동물모델을 이용한 전임상에서 기존 약물 대비 우수한 효능과 안전성을 확인했다. 이번 글로벌 임상 승인에 앞서 DWN12088은 범부처신약개발사업단 지원과제 대상으로 선정됐으며, 미국 식품의약국으로부터 희귀 의약품으로 지정된 바 있다.

박준석 대웅제약 신약센터장은 “대웅제약이 세계 최초로 개발중인 PRS 저해제 DWN12088이 FDA 희귀의약품 지정에 이어 본격적인 글로벌 임상에 착수하게 됐다”며 “폐섬유증 외에도 피부, 신장, 간, 심장 섬유증 등 다양한 섬유질환에 대한 연구를 확대해 희귀질환 R&D 역량을 더욱 강화할 것”이라고 밝혔다.

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