January 4, 2023 JAPAN – Juntendo University (Bunkyo-ku, Tokyo, President: Hajime Arai) and Metagen Therapeutics, Inc. (Tsuruoka City, Yamagata Prefecture, President and CEO: Taku Nakahara, hereinafter referred to as “MGTx”) announced that the Ministry of Health, Labor, and Welfare of Japan (MHLW) has approved their joint clinical study, “Antibiotic Fecal Microbiota Transplantation for Active Ulcerative Colitis patients” (A-FMT for UC) under its Advanced Medical Care B Program.
Japan’s Advanced Medical Care Program is a unique program and a pivotal clinical study which assesses the effectiveness and safety of innovative medical technologies through the MHLW. It was created for hospitals and clinics to accelerate the development of treatment and therapeutics by providing patient access through Japan’s universal insurance coverage, the National Health Insurance. The Advanced Medical Care Program is limited to two types of technologies; Those under the Advanced Medical Care A Program do not include unapproved agents or devices. These technologies include unapproved but minimally invasive or extracorporeal testing agents or devices. On the other hand, the Advanced Medical Care B Program includes unapproved agents or devices (except for technologies assigned to the Advanced Medical Care A Program). These technologies do not include unapproved agents or devices but require intensive monitoring and careful assessment1.
A-FMT for UC has been approved as an Advanced Medical Care B Program, becoming one of the most advanced clinical programs in the world to implement a microbiome therapy for Ulcerative Colitis (UC) as the standard of care. The program commenced at Juntendo University Hospital in January of 2023. Juntendo University and MGTx will continue to work together to verify the effectiveness and safety of their A-FMT for UC under Japan’s Advanced Medical Care B Program as they continue to progress towards the execution and management of standardized intestinal microbiota solutions.
About A-FMT for UC
A-FMT for UC utilizes advanced medical technology which aims to maximize the efficacy of conventional Fecal Microbiota Transplantation (FMT) by administering three different antibiotics in conjunction; Amoxicillin, Fosfomycin, and Metronidazole. After cleansing out the patient’s intestinal microbiota with the three different antibiotics, intestinal microbiota solution from a healthy donor is injected via endoscope into the patient to create a balanced intestinal microbiota.
In order to implement A-FMT, it is also essential to establish an ‘intestinal microbiota bank’ that registers donor candidates and collects a stool specimen to be processed for transplantation which provides a safe and stable intestinal microbiota solution. As a joint research institute, MGTx will provide various support including the recruitment of stool donors, stool specimen management, preparation of intestinal flora solution, quality control, and more.
Juntendo University and MGTx are conducting joint research towards this program with the main theme of basic clinical elucidation of therapy and its clinical application research, aiming to make it the standard of treatment in the future.
UC is an inflammatory disease of the large intestine in which erosions and ulcers occur in the mucous membrane of the large intestine. Inflammation spreads continuously from the rectum, and symptoms such as abdominal pain, chronic diarrhea, and bloody stools appear, greatly affecting the patient’s QOL.
UC is one of the designated intractable diseases with the largest number of patients (estimated to be over 200,000) in Japan2. The number of cases continue to rise each year and although the effects of treatment have improved drastically with the advent of new drug therapies in the recent years, the long-term prognosis is still unclear and side effects are also still an issue. In addition, it has become clear that the disturbance of the microbiome, or dysbiosis, is one of the factors in the onset and exacerbation of UC3.
FMT has already been put into practical use in some countries such as the United States and Australia as a treatment for recurrent Clostridioides difficile infection and recently, there have been multiple clinical studies that show positive outcomes for FMT as a treatment for patients with UC4. Juntendo University Hospital conducted a clinical study of A-FMT for UC from June 2014 to December 2022, where 210+ UC patients and 160+ stool donors participated5.
Overview of A-FMT for UC
■ Description of Research
Oral administration of three antibiotics (Amoxicillin, Fosfomycin, and Metronidazole) are used in conjunction with FMT for patients with Ulcerative Colitis (limited to mild to moderate left-sided colitis or pancolitis).
■ Purpose of Research
A-FMT is performed to examine the safety and efficacy of FMT combined with antibiotics. A multi-center, single-arm trial in patients with mild to moderate left-sided or pancolitis type UC is examined using the remission rate as the primary endpoint.
■ Facilities participating in the research
Juntendo University Hospital
Juntendo University Shizuoka Hospital
Kanazawa University Hospital
■ Joint research institutions
Metagen Therapeutics, Inc.
-Support work related to donor recruitment and stool specimen management
-Support work related to preparation, quality control, and the safe and practical transportation of intestinal flora solution
1 Ueda K, Sanada S, Uemura N. Advanced Medical Care Program for the Rapid Introduction of Healthcare Technologies to the National Health Insurance System in Japan. Clin Transl Sci. 2020 Jul;13(4):700-706. doi: 10.1111/cts.12751. Epub 2020 Feb 27. PMID: 32004408; PMCID: PMC7359945. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7359945/
2 Health, Labor and Welfare Science Research Grants Policy Research Project for Intractable Diseases Survey Research on Intractable Inflammatory Intestinal Disorder Comprehensive Research Report, Fiscal Year 2016
3 Shen ZH, Zhu CX, Quan YS, Yang ZY, Wu S, Luo WW, Tan B, Wang XY. Relationship between intestinal microbiota and ulcerative colitis: Mechanisms and clinical application of probiotics and fecal microbiota transplantation. World J Gastroenterol. 2018 Jan 7;24(1):5-14. doi: 10.3748/wjg.v24.i1.5. PMID: 29358877; PMCID: PMC5757125. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5757125/#:~:text=The%20etiology%20and%20pathogenesis%20of,to%20the%20pathogenesis%20of%20UC
4 Costello SP, Hughes PA., Waters O, Bryant RV, Vincent AD, Blatchford P, et. al. Effect of Fecal Microbiota Transplantation on 8-Week Remission in Patients With Ulcerative Colitis: A Randomized Clinical Trial. Jama. 2019; 321(2):156-164.
5 “Fecal Microbiota Transplantation for Ulcerative Colitis”. Juntendo University Hospital. https://www.juntendo.ac.jp/hospital/clinic/shokaki/about/treatment/intestinal_microbiota1.html
About Metagen Therapeutics
Metagen Therapeutics (MGTx) is a biotech startup founded by researchers of Juntendo University, Keio University and Tokyo Institute of Technology in 2020 with the mission of “continuing to fulfill the wishes of patients through microbiome science”. MGTx has been accelerating its drug discovery and development activities on intestinal microbiome-based therapeutics for various diseases such as cancer, ulcerative colitis, and Parkinson’s disease, aiming to create social impact through medical care and drug discovery. For more information, go to https://www.metagentx.com or follow us on LinkedIn at https://www.linkedin.com/company/metagentx/.
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Company name: Metagen Therapeutics Inc. (MGTx)
Head office location: 246-2 Minakami, Kakuganji, Tsuruoka City, Yamagata Prefecture
Tokyo Office: Toranomon Hills Business Tower 15th Floor, 1-17-1 Toranomon, Minato-ku, Tokyo
Representative: Taku Nakahara, President and CEO
Date of establishment: January 17, 2020
Company description: Drug discovery and medical business through microbiota therapeutics
About Juntendo University
Based on the philosophy of “Fudan Zenshin – Continuously Moving Forward,” Juntendo University values its academic motto of “Jin – I exist as you exist” and stands by the “Sanmu Shugi” which does not discriminate against school, nationality, or gender. As comprehensive medical graduate university consisting of 7 faculty departments, 3 graduate schools and 6 affiliated hospitals, Juntendo is promoting social impact and human resource development on an international level through education, research, medical care, and liberal arts. For more information, visit the Juntendo University website: https://www.juntendo.ac.jp/
University name: Juntendo University
Location: 2-1-1 Hongo, Bunkyo-ku, Tokyo
Representative: President Hajime Arai
Year Founded: 1838