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네오이뮨텍, NT-I7 'PML질환' 美 FDA 희귀의약품 지정 - 바이오스펙테이터

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네오이뮨텍, NT-I7 'PML질환' 美 FDA 희귀의약품 지정

입력 2020-06-12 09:51 수정 2020-06-12 10:00

바이오스펙테이터 장종원 기자

2019년 '특발성 CD4 림프구 감소증 치료제'에 이어 두번째 ODD.."임상개발 진행 추진"

네오이뮨텍은 11일(현지시간) 미국 식품의약국(FDA)으로부터 NT-I7(efineptakiin alfa)이 진행성 다발초점성 백질뇌병증(PML) 관련 희귀의약품지정(ODD, Orphan Drug Designation) 승인을 받았다고 밝혔다. 지난해 FDA로부터 NT-I7을 특발성 CD4 림프구 감소증 치료제로 희귀의약품 지정을 받은 이후 두번째 ODD 승인이다.

네오이뮨텍의 NT-I7은 단백질 엔지니어링 특허기술로 안정화시킨 Interleukin-7(IL-7) 분자와 단백질 지속형 플랫폼 (hyFc 기술)을 융합한 T세포 증폭제(T cell amplifier)다.

진행성 다발초점성 백질뇌병증(PML, Progressive Multifocal Leukoencephalopathy)은 면역이 저하된 사람에게 발생하며, 평소에 비활성화돼 있던 JC 바이러스(JCV, John Cunningham virus)가 재활성화하면서 나타나는 희귀하고 공격적인 기회 감염성 뇌질환이다.

PML은 뇌의 신경아교세포(glial cell)가 감염으로 인해 용해(lytic infection)되면서 뇌 백질에 진행성 손상이 나타난다. 이에 따라 뇌 신경 세포의 영구적인 손상이 발생하며, 일부의 경우는 치명적인 상황을 초래할 수도 있다. PML을 유발할 수 있는 일반적인 질환은 혈액암, 고형암, 류마티스 질환, 일차성 면역결핍증, HIV 감염이다. 현재는 PML과 JC바이러스에 대한 치료제는 없다.

네오이뮨텍의 수석부사장 겸 최고의학책임자인 NgocDiep Le 박사는 "PML 환자의 회복에서 가장 큰 장애물은 약해진 면역체계"라며 "NT-I7은 T세포의 수를 늘리고 기능을 향상시켜 면역을 회복시키는 기능을 입증했다. 별다른 치료를 받지 못하는 PML 환자들에게 치료할 수 있는 길을 열어주는 것"이라고 말했다.

양세환 네오이뮨텍 대표는 "PML 치료에 대한 NT-I7의 희귀의약품 지정은 면역 기능을 강화해 감염으로 인한 심각한 위험을 줄일 수 있는 NT-I7의 가능성을 인정받은 것"이라면서 "희귀의약품 개발은 판매독점기간을 길게 확보할 수 있으면서, 임상 기간이 짧고 비용도 크게 들지 않기 때문에 빠르게 임상개발을 진행할 계획"이라고 밝혔다.

FDA는 희귀의약품 지정을 통해 미국에서 20만명 미만의 사람들에게 발생하는 희귀질환에 대한 치료법이나 진단법 개발을 장려하고 있다.

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