초록 ▼

□ 과제 목표: 알츠하이머 치매 치료 천연물 신약 ID1201의 임상 2상 시험 승인
□ 연구 내용
1) 원료생약 품질 동등성 확보 연구: 중국 내 원료 산지 확보, 원료생약 유효성분 함량 변이 및 종 감별 연구
2) 원료의약품 생산 및 표준화 연구: 추출공정 연구, scale-up 생산, 지표성분 분석 및 성분프로파일 분석, 기준 및 시험방법 설정, 안정성 시험
3) 추가 약효/기전 연구: 추가 약효 및 기전 연구
4) 비임상 안전성 시험(GLP): 유전독성 시험, 안전성 약리 시험, 설치류/비설치류 단

□ 과제 목표: 알츠하이머 치매 치료 천연물 신약 ID1201의 임상 2상 시험 승인
□ 연구 내용
1) 원료생약 품질 동등성 확보 연구: 중국 내 원료 산지 확보, 원료생약 유효성분 함량 변이 및 종 감별 연구
2) 원료의약품 생산 및 표준화 연구: 추출공정 연구, scale-up 생산, 지표성분 분석 및 성분프로파일 분석, 기준 및 시험방법 설정, 안정성 시험
3) 추가 약효/기전 연구: 추가 약효 및 기전 연구
4) 비임상 안전성 시험(GLP): 유전독성 시험, 안전성 약리 시험, 설치류/비설치류 단회투여 독성시험, 설치류 4주/13주/26주 반복투여 독성시험, 비설치류 2주/4주 반복투여 독성시험
5) 약물동태 연구: 설치류/비설치류 단회투여 약물동태 예비시험, 비설치류 4주 반복투여 독성동태 시험
6) 완제의약품 생산 및 표준화 연구: 제형 연구, 기준 및 시험방법 설정, 안정성 시험
7) 임상 2상 시험 승인: 임상 프로토콜 설정, IND 제출서류 작성, 임상 2상 시험 승인 완료

Abstract ▼

Ⅰ. Purpose and necessity of R&D
○ Alzheimer's disease (AD) is the most common neurodegenerative disease, and the prevalence of AD rises exponentially with aging.
○ Because multiple pathogenic factors are involved in causes of AD, herbal medicines which comprises multiple compounds have the pot

Ⅰ. Purpose and necessity of R&D
○ Alzheimer's disease (AD) is the most common neurodegenerative disease, and the prevalence of AD rises exponentially with aging.
○ Because multiple pathogenic factors are involved in causes of AD, herbal medicines which comprises multiple compounds have the potential to act as multifunctional agents for AD and to produce stronger effects than a single compound via the synergistic effects of their constituents.
○ ID1201 showed high safety and efficacy profile based on its non-clinical studies. Thus, in this study, we aimed to develop herbal medicine ID1201 as a new drug for AD.

Ⅱ. Contents and scope of R&D
○ Production of drug substance (DS) and standardization study
○ Additional efficacy and mechanism study
○ Safety studies
○ Pharmacokinetics study
○ Production of drug product (DP) and standardization study
○ IND approval of phase II clinical study

Ⅲ. Results of R&D
○ Production of DS and standardization study: Securing harvest location and identification of scientific name of crude drugs, scale-up production of DS, validation of analytical method of major constituent, analyses of chemical profile, establishment of standard test method, and 9-month stability test in the long-term storage condition of DS [ completed ]
○ Additional efficacy and mechanism study: Additional in vivo efficacy and additional mechanisms [ completed ]
○ Safety studies: Genetic toxicology, safety pharmacology, single-dose toxicity studies (rats and beagle dogs), 4-week and 13-week repeated-dose toxicity studies in rats, 2-week and 4-week repeated-dose toxicity studies in beagle dogs
[ completed ], and 26-week repeated-dose toxicity study [ ongoing ]
○ Pharmacokinetics study: Pharmacokinetic study of ID1201 in rats and beagle dogs and 4 week toxicokinetic study of ID1201 in beagle dogs [completed]
○ Production of DP and standardization study: determination of drug formulation, establishment of standard test method[ completed ], and stability test of DP [ ongoing ]
○ IND approval of phase II clinical study: [ approved ]

Ⅳ. Plans for utilization of research outcomes
○ Quality control of DS and DP
○ Securing maximum period of use of DS and DP by stability tests
○ Preparation for domestic phase III clinical trial and global clinical trial by securing non-clinical toxicity studies and toxicokinetic studies
○ Promoting ID1201 by scientific paper published in a SCI journal
○ Preparation of global drug development by securing patent in China, Japan, and EU including Germany, Italy, United Kingdom, France, and Spain