Abstract ▼

Purpose&Contents
< Purpose >
When it comes to the treatment of diabetic nephropathy, the effective glycemic control and blood pressure control are considered to be important. ACEIs and ARBs, the representative therapeutic agents for diabetic nephropathy, have been proved to slow down the progr

Purpose&Contents
< Purpose >
When it comes to the treatment of diabetic nephropathy, the effective glycemic control and blood pressure control are considered to be important. ACEIs and ARBs, the representative therapeutic agents for diabetic nephropathy, have been proved to slow down the progress of diabetic nephropathy. However, several adverse effects, such as hypotension, angioedema, cough, hyperkalemia, skin rash, pollakisuria, and dizziness, caused by these drugs have been reported. Also, even though the alternative remedies (blood dialysis, peritoneal dialysis or kiney transplant) have been performed, these can bring some problems like economic burden. Natural product medicines, however, have a valuable advantage in terms of safety and a matter of adverse effects, on the authority of the fact that they have been clinically used for a long period of time and that have not affected on the human bodies compared to other agents such as chemical drugs.

Taken together, the purpose of this study is to develop a competitive treatment for diabetic nephropathy using natural products.

○ The stable supply and demand of raw materials and the quality control
: Due to the fact that natural products are composed of various compounds, the stable supply and demand and the quality control of the raw materials used for the development of natural product medicines are the most integral parts for consistency of the drug effects. While performing this study, we plan to establish the criteria of the quality control and determine the optimal supplier.

< Contents >
○ Manufacturing of drug substance and drug product for the clinical trial : The drug substance (AG NRF803), the drug procut (AG NRF 400 mg), and placebo drugs are produced for the phase II clinical trial.

○ Non clinical study (GLP)
: A 26-week repeated oral toxicity study in Sprague-Dawley rats with a 4-week recovery period
: Fertility and early embryonic development study

○ Value-up study : in vitro/in vivo studies for the purpose of extension of the indications, finding product differentiation (strong advantages) and investigating mode of actions

○ Clinical study
: Therapeutic exploratory and dose adjustment study of type II diabetic nephropathy patients with microalbuminuria (ACR 30~299 ug/mg creatinine), using two different doses of AG NRF803 and a placebo drug

○ Stability tests
: Stability testing of drug substance and drug product according to MFDS Notification “Regulation on Stability test of Medicinal Products”

○ Protocol study for phase III clinical trial/IND approval from MFDS
: Developing of a protocol for phase III clinical trial and getting approval from MFDS

Results
○ The stable supply and demand of raw materials and the quality control
: Physiochemical tests, content tests and chemical profiling were performed to control the quality of raw material, and the optimal supplier has been determined, as a result.

○ Manufacturing of drug substance and drug product for the clinical trial
: Fifty six kg of drug substance (AG NRF803) and 60,000 tablets of each drug product (AG NRF 400 mg정) and placebo drug were produced.

○ Non clinical study (GLP)
: The safety has been proved through the study “A 26-week repeated oral toxicity study in Sprague-Dawley rats with a 4-week recovery period”.

: The safety has been proved through the study “Fertility and early embryonic development study in Sprague-Dawley rats”.

: The safety has been proved through the study “Fertility and early embryonic development study in New Zealand White rabbits”.

○ Value-up study : The isolation of the single chemical compounds from AG NRF803 and the mechanism study of AG NRF803 in regard to its therapeutic efficacy for diabetic nephropathy

○ Clinical study : IRB approval was obtained from 7 clinical trial institutions and the enrollment of patients and the study results was performed.

○ Stability tests
: Stability test for the drug substance was performed. (Long term stability test 36 M, Accelerated stability test 6 M)

: Stability test for the drug product was performed. (Long term stability test 36 M, Accelerated stability test 6 M)

○ Protocol study for phase III clinical trial/IND approval from MFDS : Protocol study for Phase III clinical trial was processed

Expected Contribution
Based on the results of this study, more non clinical study and Phase II clinical trial in advised protocol will be performed.

After the optimal dose with safety and efficacy is determined, through the successful performance of the phase II clinical trial, phase III clinical trial is supposed to be performed. NDA filing and approval will be followed by the successful phse III clinical trial with sufficient documents related to non-clinical test results and CMC.

Thereafter, AG NRF803 is expected to be launched as a new natural product medicine for diabetic nephropathy. Further, it could be expected to contribute to health and medical industry as well as improve the quality of lives of the patients with diabetic nephropathy.

Lastly, it is expected that this new drug could contribute to the growth of the national economy through overseas expansion by export of the product or by the technical transfer.

(출처 : SUMMARY 5p)

목차 Contents

• 표지 ... 1
• 제 출 문 ... 2
• 보고서 요약서 ... 3
• 국문 요약문 ... 4
• SUMMARY ... 5
• 영문목차 ... 6
• 목차 ... 7
• 1. 연구개발과제의 개요 ... 8
• 1-1. 연구개발 배경 및 필요성 ... 8
• 2. 국내외 기술개발 현황 ... 12
• 3. 연구수행 내용 및 결과 ... 13
• 3-1. 연구개발 추진전략 ... 13
• 3-2. 연구개발 추진일정 ... 14
• 3-3. 연구개발성과 ... 16
• 3-4. 연구내용 및 결과 ... 21
• 4. 목표달성도 및 관련분야 기여도 ... 80
• 4-1. 목표달성도 ... 80
• 4-2. 관련분야 기여도 ... 81
• 5. 연구결과의 활용계획 ... 82
• 5-1. 연구개발결과의 활용방안 ... 82
• 5-2. 기대효과 및 파급효과 ... 82
• 5-3. 추가 연구 계획 ... 83
• 6. 연구과정에서 수집한 해외과학기술정보 ... 86
• 7. 연구개발성과의 보안등급 ... 87
• 8. 국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 87
• 9. 연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 87
• 10. 연구개발과제의 대표적 연구실적 ... 88
• 11. 기타사항 ... 89
• 12. 참고문헌 ... 90
• 끝페이지 ... 91