Abstract ▼

□ Purpose&Contents
◈ Research purpose
- Aim to develop a therapheutic for Alzheimer's disease using a drug that induces neurogenesis of endogenous neural stem cells (NSCs)
- Aim to develop a fundamental treatment for Alzheimer's disease (AD) and to secure safety through drug re-purposing

□ Purpose&Contents
◈ Research purpose
- Aim to develop a therapheutic for Alzheimer's disease using a drug that induces neurogenesis of endogenous neural stem cells (NSCs)
- Aim to develop a fundamental treatment for Alzheimer's disease (AD) and to secure safety through drug re-purposing

◈ Research content
- Based on a novel MOA (Mode of Action) that an induced neurogenesis from endogenous NSCs can recover damaged neural networks, SNR1611, a repurposing drug withcapabilities of neuroregenerative and neuroprotective capabilities, was screened.
① Research
: SNR1611’s ability to reach the brain tissue was examined by pharmacokinetic studies
: Through various analyses, it was confirmed whether SNR1611 can restore neural activities damaged in the brain of AD-model mice through its neuro-regenerativecapacity.
: Biomarker candidates indicative of the efficacy of SNR1611 were identified
: In primates, SNR1611’s safety and in vivo efficacy were examined
② IND
: Pre-IND meeting was hold in order to secure the necessities for US IND submission
: Prepare the IND package in order to submit them to US-FDA

□ Results
◈ Secure non-clinical results for IND submission
: PK studies indicated that amidnistered SNR1611 can reachg the brain, and B/P ratio is 0.48~0.64. By the PD analyses, it was confirmed the target molecule of SNR1611 is regulated in the brain.
: In 5XFAD mice, SNR1611 administration activated neuronal differentiation of endogenous NSCs. As results, neuron numbers, neuronal homeostasis and network were recovered, so as to restore cognitive functions
: Methods to evaluate indicative biomarkers were developed and biomarker candidates were thus selected
: In primates, MRS study suggested possible endogenous neurogenesis and safety of long-term administration of SNR1611 was also confirmed.
◈ Secure non-clinical results for IND submission
: Clinical trial modules including non-clinical test results report and clinical trial data book (IB) were secured
: The IND package was submitted to US-FDA for the indication of AD

□ Expected Contribution
◈ A fundamental therapeutic for Alzheimer's disease will be introduced
- The concept of “Restoration of neural network through neurogenesis of endogeneous NSCs” will provide a new therapeutic target for the treatment of AD and the application will be expanded to apply for other neuneurodegenerative diseases
- For example, SNR1611 is now under phase 1/2a clinical study for the indication fo ALS in Korea.
◈ Creation of new businesses through the novel strategy in drug development for AD
- Introduce a new AD-drug development strategies, which do not target amyloid beta aggreagation
- Possible licensing out to Big Pharma
◈ Following-up researches
- Discovery of new chemical entities through the platforms developed in this research
- New formulation of the drug developed through this study

(source : SUMMARY 14p)

목차 Contents

• 표지 ... 1
• 보고서요약 ... 2
• 제출문 ... 11
• 보고서 요약서 ... 12
• 국문 요약문 ... 13
• SUMMARY ... 14
• Contents ... 15
• 목차 ... 16
• 1. 연구개발과제의 개요 ... 18
• 1-1. 연구개발 목적 ... 18
• 1-2. 연구개발의 필요성 ... 18
• 1-3. 연구개발 범위 ... 18
• 2. 국내외 기술개발 현황 ... 19
• 3. 연구수행 내용 및 결과 ... 26
• 4. 목표달성도 및 관련분야 기여도 ... 42
• 4-1. 연도별 연구목표 ... 42
• 4-2. 평가의 착안점 ... 43
• 4-3. 연구개발목표의 달성도 ... 44
• 4-4. 관련분야에의 기여도 ... 47
• 5. 연구결과의 활용계획 ... 48
• 5-1. 추가연구의 필요성 및 다른 연구에의 응용 ... 48
• 6. 연구과정에서 수집한 해외과학기술정보 ... 51
• 7. 연구개발성과의 보안등급 ... 51
• 8. 국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 51
• 9. 연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 51
• 10. 연구개발과제의 대표적 연구실적 ... 52
• 11. 기타사항 ... 52
• 12. 참고문헌 ... 53
• 끝페이지 ... 55