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큐리언트, 내성결핵 치료제 '텔라세벡' "NEJM 임상 발표" - 바이오스펙테이터

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큐리언트, 내성결핵 치료제 '텔라세벡' "NEJM 임상 발표"

입력 2020-03-26 09:24 수정 2020-03-26 17:21

바이오스펙테이터 김성민 기자

결핵치료제 임상연구 분야 권위자 안드레아스 다이아콘 교수 NEJM에 텔라세벡 신규 결핵치료제과 병행...차세대 치료법을 완성하기 위한 약물이라고 언급

▲doi: 10.1056/NEJMc1913327

큐리언트가 개발 중인 내성결핵제료제(텔라세벡, Q203)의 임상2A상 결과가 세계 최고 권위의 학술지인 NEJM(New England Journal of Medicine)에 게재됐다. NEJM은 세계에서 가장 영향력 있는 의학 저널로 영향지수(Impact Factor)가 71로 가장 높다. 큐리언트에 따르면 국내에서 최초 개발한 'first-in-class' 혁신신약의 임상 결과가 NEJM에 발표된 첫 번째 사례다.

큐리언트는 지난해 텔라세벡의 임상2a상에서 1, 2차 유효성 충족점과 안전성 평가 목표를 달성했다고 발표했으며, 2018년 미국 식품의약국(FDA)으로부터 결핵치료제로 신속심사 대상으로 지정된 바 있다.

이번 NEJM 논문에서 결핵치료제 임상연구 분야 최고 권위자인 안드레아스 다이아콘(Andreas Diacon) 박사팀은 '새로운 결핵 치료제 텔라세벡(Telacebec(Q203), a New Antituberculosis Agent)'이란 제목으로 텔라세벡 임상2A상(NCT03563599)의 결과와 의미를 설명했다.

1차 평가 지표인 TTP(Time to Positivity) 분석을 통해 단독 투약 14일만에 결핵균의 활성도 저하를 확인하였고 100mg, 200mg, 300mg 의 투여용량에 정비례하는 약효를 도출했으며, 약물 관련 부작용 사례도 발생하지 않았다.

안드레아스 교수는 이러한 임상결과에 따라 텔라세벡이 신규 결핵치료제와 병행 처방을 통해 차세대 치료법을 완성하기 위한 약물이라고 강조했다.

남기연 큐리언트 대표는 “결핵은 단기간에 치료효과를 얻기 어려운 특성이 있는데, 이번 발표는 텔라세벡의 탁월한 임상결과를 글로벌 학계가 인정한 것이며 텔라세벡의 기술적, 사업적 가치를 업그레이드하는 계기가 됐다"며 "이와 함께 큐리언트는 탄탄한 과학적 근거를 기반으로 항암, 항염증 질환의 신약개발에 매진하고 있다"고 밝혔다.

▲투여농도별 결핵균 활성도 감소결과 (Day), 회사 제공.

또한 앞선 23일 미국 존스홉킨스대학, 네델란드 흐로닝언대학과 큐리언트가 공동으로 발표한 미국 미생물학회(American Society for Microbiology)에서 발간하는 Antimicrobial Agents and Chemotherapy 저널에 “Telacebec for ultra-short treatment of Buruli ulcer in a mouse model”에 따르면 생쥐모델에서 Telacebec(Q203) 단독처방으로 희귀 난치질환인 부룰리궤양을 1주일 이내에 치료할 수 있다는 연구결과를 발표하며 신속한 임상 진입을 강조했다.

한편 다제내성결핵은 매년 50만명의 신규환자가 발생하고 치사율이 30~50%에 이르는 심각한 질병이다. 그러나 현재 시판된 약물은 얀센의 베다퀼린, 오츠카제약의 델라마니드(delamanid) 등 3가지로 내성균을 치료하기 위한 병용처방법이 제한적이다.

큐리언트의 텔라세벡은 결핵균의 전달전달계의 시토크롬C(CytochromeC) 구성요소인 QcrB subunit을 타깃해, 결핵균의 호흡을 저해하는 신규 기전의 약물이다. 텔라세벡은 결핵균에만 작용해 약물내성 및 부작용을 최소화했다. 앞서 텔라세벡(Q203)은 지난 2013년 네이처 메디슨(Nature Medicine)에도 주목받는 새로운 기전의 임상 후보물질로 소개된 바 있다.

큐리언트는 한국파스퇴르연구소로부터 결핵치료제 기초 기술을 도입하여 텔라세벡을 개발했으며, 전임상부터 임상2A상까지 범부처신약개발사업단 과제로 선정되어 지원을 받아왔다.

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