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엔지켐생명과학 "급성방사선증후군 임상 FDA 승인" - 바이오스펙테이터

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엔지켐생명과학 "급성방사선증후군 임상 FDA 승인"

입력 2019-05-13 17:23 수정 2019-05-13 17:34

바이오스펙테이터 장종원 기자

방사능 노출 2상 '영장류 대체' 인정..하반기 임상시험 돌입

엔지켐생명과학은 11일(현지시간) 미국 식품의약국(FDA)로부터 신약물질 EC-18의 급성방사선증후군(ARS) 적응증 시험계획을 승인받았다고 밝혔다.

이번 시험계획은 인체에 치명적인 방사선을 조사받아야 해 약물의 효능을 확인하는 임상 2상 시험을 영장류로 대체해 진행(Animal Rule)하게 된다. 해당 영장류 실험은 올해 하반기 시작될 예정으로 시험 종료시 임상 2상 시험을 마친 것으로 인정받게 된다는게 회사측의 설명이다. 실제 작년 미국에서 ARS 치료제로 허가받은 이스라엘 플루리스템의 'PLX-R18' 역시 영장류 대체 임상으로 허가받았다.

엔지켐생명과학 관계자는 "이번 신약은 급성방사선증후군(ARS)의 다양한 증상(조혈, 위장관, 폐 ARS)에 적용 가능할 뿐만 아니라, 경구 투약이 가능하고 보관이 용이해 현장사용(에 적합하다"면서 "미 국립 알레르기 및 전염질환연구원(NIAID)의 핵심 정부자금 지원 프로그램, 방사능핵무기대응프로그램(RNCP)과 화학무기대응연구프로그램(CCRP)에 중복 선정돼 지원을 받는 등 미국 정부, 국책기관과 치료제 개발 협업 프로그램을 논의하고 있다"고 말했다.

이번 임상 역시 미국 국립보건원 및 생의학연구개발청의 기금을 받아 공동연구로 진행될 예정이다.

손기영 엔지켐생명과학 대표는 “이번 2상 상응 시험승인을 시작으로 NIAID, BARDA의 지원 및 공동 연구가 시작된다”면서 “의료대응조치(MCM)를 위한 미국정부와의 협력을 강화해, 15억 달러 규모인 ARS 관련 시장에 안착하겠다"고 말했다. 엔지켐생명과학은 2017년 EC-18의 급성방사선증후군에 대한 희귀의약품지정을 받은 바 있다.

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