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올릭스, IPF RNAi 치료제 도전..내년 美 1상 신청

입력 2019-04-12 09:45 수정 2019-04-12 09:45

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'폐섬유화 주요 유전자인 CTGF 억제'..섬유화 관련 파이프라인 확대 검토

RNAi 신약개발기업 올릭스가 특발성폐섬유화(IPF) 치료제를 새로운 신약 파이프라인에 추가했다.

12일 올릭스에 따르면 OLX201는 폐섬유화의 주요 유전자인 CTGF(Connective Tissue Growth Factor)를 억제하는 흡입제형(nebulizer inhalation)의 RNAi 신약후보물질이다. CTGF는 결합조직 생성인자 또는 연결조직 성장인자로 인체 내 섬유화 촉진의 주요 인자로 알려져 있다.

OLX201는 한국보건산업진흥원 첨단기술개발사업으로 싱가포르 국가기관인 A*Star와 공동 국제과제를 통해 개발했다. OLX201는 동물(마우스) 모델에서 특발성폐섬유화 치료제로서의 가능성을 확인했으며 최근 미국 특허 등록도 마쳤다.

현재 올릭스는 특발성폐섬유화치료제 관련 논문 발표를 준비 중이며, 내년 미국 식품의약국(FDA) 임상 1상 승인신청을 계획 중에 있다.

올릭스 관계자는 "이번에 등록된 특발성폐섬유화 치료제의 미국 특허 청구항에는 인체 내 모든 CTGF를 타겟할 수 있는 광범위한 조항이 포함돼 있어 체내 다양한 섬유화 관련 질환의 파이프라인을 추가적으로 확장 할 수 있다"고 설명했다.

이에 따라 올릭스는 비대흉터치료제, 특발성폐섬유화치료제, 망막하섬유화체료제 등 현재 파이프라인 외 추가적인 섬유화 질환의 파이프라인 확보를 검토하고 있다.

한편 올릭스는 RNAi 구조 관련 원천 플랫폼 기술인 긴비대칭 siRNA (lasiRNA)의 유럽 특허가 최근 등록 완료됐다고 밝혔다. 이에 따라 올릭스는 미국, 유럽, 중국, 한국, 일본 등 글로벌 주요 국가의 독점적 권리를 확보하게 됐다.

올릭스가 자체 개발한 RNAi 플랫폼 기술은 비대칭 구조로 표적 유전자의 유도와 억제 효율 및 지속기간을 증가시키고, 기존 RNAi 기술 대비 면역 독성 등의 부작용을 개선해 세포 내 효율적으로 전달할 수 있는 구조적인 강점을 가지고 있다.

이동기 올릭스 대표는 “올릭스의 RNAi 플랫폼 기술의 독점적 권리 확보로 인해 다양한 난치성 질환을 앓고 있는 환자들에게 희망과 근본적인 치료의 방향성을 제시할 수 있게 됐다"면서 "향후 올릭스는 다양한 적응증으로 파이프라인을 확장하며 신약개발과 기술이전의 새로운 패러다임을 제시하겠다"고 말했다.

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