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크리스탈, 슈퍼박테리아 항생제 유럽 1상 승인 - 바이오스펙테이터

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크리스탈, 슈퍼박테리아 항생제 유럽 1상 승인

입력 2019-08-30 16:01 수정 2019-08-30 16:20

바이오스펙테이터 조정민 기자

MRSA·VRSA 적응증 슈퍼박테리아 항생제 CG-549… “복용 편의성↑·제조원가↓ 제형 개발해 임상 재개”… 네덜란드서 수행

크리스탈지노믹스는 30일 네덜란드 국가임상심의기관으로부터 슈퍼박테리아 항생제 신약후보 ‘CG-549’의 임상1상을 승인받았다고 밝혔다.

CG-549는 가장 빈번하게 발생하는 슈퍼박테리아로 알려진 MRSA(메치실린내성황색포도상구균) 및 VRSA(벤코마이신내성황색포도상구균)를 적응증으로 개발 중인 신개념 슈퍼박테리아 항생제다.

크리스탈은 원래의 캡슐제형을 제형개선 연구를 통해 생체이용율을 높임으로써 1회 복약갯수와 제형크기를 대폭 감소시키고 환자의 복약순응도를 높인 정제(Tablet)를 개발했다. 캡슐 제형 대비 크기 감소는 물론 제조공정을 단순화해 제조원가를 낮춘 공정개발을 완료하고 관계사인 크리스탈생명과학㈜에 완제생산 기술이전을 진행, 안정적인 대량 생산 기반을 갖추게 됐다.

이번에 허가받은 임상1상은 건강한 성인을 대상으로 경구용 CG-549정제의 안전성과 내약성, 약동학적 특성을 평가하게 된다. 크리스탈과 계약한 글로벌 임상시험수탁기관인 PRA Health Science는 네덜란드 소재의 병원에서 임상시험 대상자를 모집해 임상을 진행하고 임상생체분석은 미국의 PRA 분석실험실에서 수행한다. 이를 위해 현재 미국 PRA에서 분석법 개발 및 검증을 진행 중이다.

크리스탈은 이번 임상을 통해 CG-549 정제의 최적 투여량을 결정하고 안전성 및 약동학적 특성 데이터를 확보해 미국 또는 유럽에서 슈퍼박테리아인 MRSA(메치실린내성황색포도상구균)를 대상으로 임상2상을 수행할 계획이다.

조중명 크리스타 대표이사는 “미국에서 MRSA 감염환자를 대상으로 임상2a상을 진행해 우수한 약효와 안전성을 확인한 바 있는 CG-549를 다년간의 연구 끝에 정제 제형을 개발해 임상시험을 재개하게 돼 기쁘게 생각한다”며 “임상시험을 신속히 진행해 성공적인 결과를 얻기 위해 최선을 다할 것”이라고 말했다.

한편 크리스탈의 CG-549 제형개선작업은 범부처신약개발사업단의 연구비를 지원받아 진행됐다.

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