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신풍제약, 新기전 항혈소판제 신약 영국 1상 승인 - 바이오스펙테이터

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신풍제약, 新기전 항혈소판제 신약 영국 1상 승인

입력 2019-03-20 11:26 수정 2019-03-20 11:26

바이오스펙테이터 장종원 기자

영국 MHRA에서 임상 1상 시험계획서 승인...상반기 돌입 예정

신풍제약이 올해 상반기 항혈소판제 신약 개발을 위한 영국 임상 1상에 돌입한다.

신풍제약은 20일 항혈소판제 신약후보물질 SP-8008이 영국의약품보건의료제품규정청(MHRA, Medicinesand Healthcare Products Regulatory Agency)의 임상 1상 승인(CTA)을 받았다고 밝혔다.

이에 따라 신풍제약은 오는 5∼6월 중 영국 현지에서 지원자(48명)를 대상으로 안전성과 약동학평가를 위한 임상 1상을 개시할 계획이다.

혈소판 응집은 지혈작용에 필수적이나 과도하게 활성화되는 경우 혈전을 발생시켜 관상동맥질환, 뇌졸중과 같은 심혈관계 질환을 유발한다. 아스피린, 클로피도그렐과 같은 기존 항혈소판제제의 경우 심혈관계 질환에 대한 약효 및 예방효과가 입증됐지만 동시에 정상적인 지혈작용까지 저해해 출혈부작용이 우려된다.

신풍제약의 SP-8008은 신규기전을 가진 혁신신약이다. 현재 서울대약대 정진호 교수팀, 고려대약대 이기호 교수팀과 공동연구로 보건복지부 첨단의료기술개발사업과제로 선정돼 지원받고 있다.

혈소판은 동맥경화 등 좁아진 혈관에서 급격히 증가되는 물리적인 전단응력(shear stress, 혈류에 의해 혈관에 미치는 압력)에 의해서도 활성화되는데 이는 정상적인 지혈작용에는 크게 관여하지 않으면서 병적인 상태에서의 혈전생성에 선택적으로 관여한다. SP-8008은 바로 이 활성화과정 중 혈관에서 유리되는 활성화물질인 vWF작용을 억제한다. SP-8008은 다양한 질환동물모델에서 출혈부작용은 획기적으로 감소시키는 반면, 기존혈소판제제와 유사한 혈소판응집억제효과를 보였다는게 회사측의 설명이다.

신풍제약의 주청 연구본부장은 "SP-8008은 신풍의 합성기술로 원료부터 생산해 경구용제제로 개발될 예정"이라면서 "이번 1상에서는 혈액에서의 혈소판활성변화도 측정돼 유효성에 대한 예비평가도 가능한 바 개발속도에 더욱 박차를 가할 예정’이라고 말했다.

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