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액티코, 출혈 위험성↓ 혈전억제제 ‘ACT017’ 1상 결과발표 - 바이오스펙테이터

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액티코, 출혈 위험성↓ 혈전억제제 ‘ACT017’ 1상 결과발표

입력 2019-04-22 06:39 수정 2019-04-22 06:42

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first-in-class 항 혈소판 항체 ‘ACT017', 혈소판 응집작용 억제

프랑스 스타트업 액티코 바이오텍(Acticor Biotech)은 혈전 억제제 ‘ACT017’ 임상 1상 결과를 SCI급 학술지 『Arteriosclerosis, Thrombosis, and Vascular Biology』에 지난 18일(현지 시간) 게재했다(DOI: 10.1161/ATVBAHA.118.312314).

‘ACT017’은 혈소판의 GPVI(Glycoprotein VI) 활성을 억제하는 퍼스트 인 클래스(first-in-class) 항 혈소판 항체다. GPVI는 혈소판 응집작용(Platelet aggregation)에 관여하는 단백질이다. ‘ACT017’은 GPVI 활성을 막아 혈소판 응집작용을 억제한다. 항 혈소판 항체는 면역성 혈소판감소증(Immune thrombocytopenia)의 원인으로 알려졌지만, 액티코는 항 혈소판 항체의 혈전 제거 가능성에 주목했다.

임상 1상은 건강한 피험자 36명을 대상으로 ‘ACT017’을 정맥주사로 6시간 동안 투여했다. 용량은 62.5mg, 125mg, 250mg, 500mg, 1000mg, 2000mg 6가지로 나누어 진행됐으며, 억제제의 안전성, 내약성을 평가했다.

‘ACT017’를 투여한 즉시 혈소판 응집작용이 억제됐다. 출혈 위험지표인 출혈 시간은 평균 5.45분(범위 3분~9.5분)으로 나타났고, 모든 용량에서 비슷한 출혈 시간을 보였다. 약효의 지속 시간은 용량에 비례했다. 혈소판 활성은 7일 이내에 투여 이전 수준으로 회복됐다. 심각한 부작용은 나타나지 않았으며, 가벼운 두통만 발견됐다.

뇌졸중은 혈소판 응집작용으로 생긴 혈전이 뇌혈관을 막거나 파열시켜 생긴다. 재발위험도가 높아 혈전 억제제를 계속 투여해야 한다. 현재는 COX-1 억제제 ‘아스피린(Aspirin)’, P2Y12 억제제 ‘플라빅스(Plavix, 성분명 Clopidogrel)’ 병용요법으로 혈소판 활성을 억제한다. 병용요법으로 혈류는 개선되지만, 출혈 시간이 증가하고 혈소판 수가 감소하는 출혈성 부작용이 생긴다. 혈전 억제제 투여를 시작한 이후에는 가벼운 자극에도 출혈이 발생하며 지혈이 되지 않는다.

이번 임상 1상은 건강한 피험자를 대상으로 진행됐기에, 환자를 대상으로 진행하는 임상 1b/2a상 결과를 확인해야 한다. 환자 대상의 임상시험을 거쳐 성공적으로 출시된다면, 혈전 억제제의 단점이었던 출혈성 부작용을 줄일 수 있을 것이다. 3대 심혈관계 질환인 심근경색, 뇌졸중, 폐색전증(Pulmonary embolism) 모두 혈전이 일으킬 수 있는 질환이므로, 항 혈소판 항체의 활용방안은 더욱 많아질 것이다.

한편 2018년 10월, 액티코는 벨기에 Newton BioCapital, 한국 미래에셋캐피탈, 프랑스 CapDecisif Management로부터 1530만 유로의 시리즈B 투자 유치에 성공했다. 액티코는 올해 안으로 ‘ACT017’ 임상 1b/2a상을 시작할 계획이며, 폐색전증 환자를 대상으로도 임상시험을 준비하고 있다.

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