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강스템바이오텍, 아토피 줄기세포치료제 3상 투약 완료 - 바이오스펙테이터

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강스템바이오텍, 아토피 줄기세포치료제 3상 투약 완료

입력 2018-12-14 11:47 수정 2018-12-14 11:47

바이오스펙테이터 장종원 기자

'퓨어스템-AD' 내년 하반기 임상 결과 발표 및 품목허가 신청 기대

강스템바이오텍이 국내 3상을 진행중인 아토피피부염 줄기세포치료제 ‘퓨어스템-AD주’의 환자 투약을 마무리했다. 강스템바이오텍은 내년 하반기 긍정적인 임상 결과가 도출되면 국내 품목허가 신청에 돌입할 예정이다.

강스템바이오텍은 14일 ‘퓨어스템-AD주’의 3상 임상 마지막 환자 투약이 완료됐다고 밝혔다. 작년 12월 식품의약품안전처의 임상 3상 승인을 얻은 이후 1년여만에 환자모집과 투약을 마무리했다.

이번 임상시험은 서울 성모병원, 아산병원, 전남대병원, 부산대병원 등 국내 11개 대형병원에서 총 194명의 중등도 이상 아토피 성인환자를 대상으로 진행됐다. 세포 용량은 임상1/2a상에서 고용량 투여시 사용했던 5.0x10^7셀(cell)로 단회 피하주사 투여했다.

임상 설계에 따라 마지막 투여환자의 관찰기간(6개월)이 끝나는 내년 6월말이면 3상이 공식 종료된다. 강스템바이오텍 관계자는 "내년 하반기 임상시험 결과가 나오는 대로 품목허가 및 상용화 절차를 진행할 계획"이라고 설명했다.

강스템바이오텍은 지난달 28일 발표한 1/2a상 3개년 장기추적결과에서 의미있는 유효성 및 안전성이 확인된 만큼 3상에서도 긍정적인 결과가 나올 것을 기대하고 있다.

회사 관계자는 "현재 시판중인 케미컬 약은 대부분 경등도 중심 치료제로 ‘퓨어스템-AD주’가 개발되면 중등도 이상 아토피피부염 치료제 시장은 항체 치료제와 양분될 것"이라고 강조했다. 국내 기준 중등도 이상 성인 아토피 환자수는 30만명으로 추산된다.

한편 강스템바이오텍은 ‘퓨어스템-AD주’의 유럽 임상시험도 추진하고 있다. 2019년 유럽의약품청으로부터 임상시험계획서(CTA)를 승인받아 유럽 2상에 진입한다는 계획이다. 지난 10월에는 벨기에 마스터셀(MaSTherCell), 프랑스 바이오트라이얼(Biotrial)과 의약품위탁임상(CRO) 계약을 체결했다.

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