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한올바이오, 안구건조증 신약 "3상 탑라인 결과 발표" - 바이오스펙테이터

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한올바이오, 안구건조증 신약 "3상 탑라인 결과 발표"

입력 2020-01-16 10:13 수정 2020-01-16 10:13

바이오스펙테이터 김성민 기자

한올바이오파마-대웅제약 공동개발 안구건조증 HL036 탑라인 임상3상 결과 발표...객관적 지표 TCSS HL036 0.25% 점앤액 위약 대비 개선효과 확인, 주관적 지표 ODS서는 2주, 4주서 개선효과 확인

한올바이오파마와 대웅제약이 공동개발하고 있는 안구건조증 치료제 'HL036'의 첫 번째 미국 임상3상 탑라인(topline) 결과를 공개했다.

이번에 발표한 HL036의 VELOS-2 Study 임상3상은 안구건조증 환자 637명을 두 그룹으로 나눠 HL036 0.25% 점액안 또는 위약(placebo)를 8주 동안 1일 2회 점안했다. 유효성을 평가하는 지표로 2가지를 평가했다. 객관적 지표(sign)로 손상된 각막의 개선 정도를 직접 측정하는 각막염색지수(sorneal staining score, CSS)와 주간적 지표(symptom)로는 환자가 느끼는 눈 불편감을 설문조사하는 ODS(ocular discomfort score)를 이용했다. 임상3상은 미국의 안과전문 CRO인 오라(Ora)를 통해 미국내 12개 임상기관에서 진행했다.

임상 결과 각막 전체에서 나타나는 효과를 종합 반영하는 객관적 지표인 TCSS(total corneal staining score)에서 위약 대비 통계적으로 유의미한 개선 효과를 확인했다. TCSS는 각막을 하부(inferior), 중앙부(central), 상부(superior)로 나눠 각 부위에서 효과를 측정해 합산한 값이다. 임상2상에서 이용한 ICSS(inferior corneal staining score) 지표와 비교해 안구 전체에서 효과를 확인한다는 점에서 임상적으로 더 의미있는 값이다.

또한 주관적 지표인 ODS(ocular discomfort score)에서 HL306 0.25% 점안액을 투여한지 2주와 4주에서 위약군 대비 뚜렷한 개선효과를 확인했다. 약물 부작용은 모두 경미한 수준으로 두 그룹간의 차이가 없었다.

임상개발 책임자인 조지 오슬러(George Ousler) 박사는 “이번 임상시험에서 HL036의 각막손상 개선 효과가 각막의 특정 부위에 국한되지 않고 각막 전체에서 나타난 것은 임상적으로 매우 중요한 의미를 갖는다"며 "또한 HL036의 주관적 증세 개선효과는 투약 후 2주와 4주에 빠르게 나타나므로 투약기간이 길어질수록 위약 효과가 커지는 것을 감안할 때 두 번째 임상 3상은 증세 개선 판단시점을 짧게 하여 임상시험을 진행하면 될 것”이라고 말했다.

박승국 한올바이오파마 대표는 “이번에 발표된 사항은 현재까지 확인된 탑라인 결과다. 최종 결과는 바이오마커 분석, 질환의 중증도와 HL036 효과의 상관성 분석 등 다양한 하위그룹(sub-group) 분석을 마치고 해외 안과학회를 통해 발표할 예정"이라며 "이번 첫 번째 임상3상 결과를 바탕으로 해외 파트너들과 라이선스 협의를 진행해 나갈 것이며, 더불어 치료 효과를 재현 확증하기 위한 두 번째 임상3상도 준비할 것”이라고 밝혔다.

HL036 안구건조증 치료제는 한올이 자체 원천기술인 레지스테인(resistein) 기술을 이용해 TNF 수용체 절편을 분자 개량한 바이오신약이다. 2016년 대웅제약과 공동개발 계약을 체결하고 함께 글로벌 임상개발을 진행하고 있다.

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