(Seoul = Yonhap News) Reporter Seung-Hyun Gye = The Ministry of Food and Drug Safety announced on the 22nd that it has formed and started operating a productization support team to support the domestic development of microbiome treatments.
Microbiome refers to the entire genetic information of microbes or microbes themselves that exist in a specific environment. Treatments related to psoriasis, reflux esophagitis, and obesity are being developed using this.
Currently, 5 products in the US and UK are in phase 3 clinical trials for treatments using microbiome. In Korea, one item was approved for phase 1 clinical trial.
The support team plans to prepare guidelines such as quality, nonclinical and clinical data requirements taking into account microbiome characteristics.
[촬영 이승민]
[표] Current status of microbiome treatment in Korea during clinical trials
| Enterprise | Pipeline | Indication | Progress |
| Genome & Company | GEN-001 | Immunotherapy | US Phase 1/1b clinical trial IND approval Approval of Phase 1 IND by the Ministry of Food and Drug Safety |
| Go Bio Lab | KBLP-001 | Autoimmune diseases such as atopy, inflammatory bowel disease, and psoriasis | Phase 1 clinical trial in Australia in progress (end of drug) Approved for IND phase 2 clinical trial Application for IND for Phase 1 of the Ministry of Food and Drug |
| KBLP-002 | Allergic immune diseases such as atopic dermatitis and asthma | Australian Phase 1 clinical IND approval | |
| Cloth wrap | CLCC1 | Solid rock | `21 Phase 1 clinical trial in Australia |
※ Provided by the Ministry of Food and Drug Safety.
Unauthorized reproduction-redistribution prohibited>
2020/12/22 09:00 sent