Announcement of a Specific Clinical Study Using 5-aminolevulinic Acid (5-ALA) for COVID-19 Patients by Nagasaki University
10/29/2020
Announcement of a Specific Clinical Study Using 5-aminolevulinic Acid (5-ALA) for COVID-19 Patients by Nagasaki University
Nagasaki University, a national university corporation (Nagasaki City, Nagasaki Prefecture, President Shigeru Kawano: hereafter, Nagasaki University) and NeoPharma Japan Co., Ltd. (Headquartered in Fujimi, Chiyoda-ku, Tokyo, CEO Satoshi Kawata: hereafter, NPJ) have initiated a specific clinical study using 5-ALA (5-aminolevulinic acid), which NPJ develops, manufactures, and researches, targeting patients with COVID-19 (coronavirus disease).
5-ALA is a naturally occurring amino acid synthesized in the cells of humans, animals, and plants, and is also found in food, making it a part of our daily intake. Due to its high safety and functional properties, it has been utilized in various healthcare products for over a decade.
Professor Kiyoshi Kita of Nagasaki University’s School of Tropical Medicine and Global Health, along with NPJ, has been focusing on the functional aspects of 5-ALA and advancing the development of malaria treatments. Currently, clinical studies are being conducted in Laos in collaboration with Professor Shigeyuki Kano and others from the National Center for Global Health and Medicine. Given 5-ALA’s broad-spectrum potential against various infections, Nagasaki University and NPJ are extensively exploring its effects on tropical diseases.
Given the high societal demand related to COVID-19, research has commenced using the SARS-CoV-2 virus in vitro, showing strong inhibitory effects of 5-ALA on virus infection. These cell test results have been submitted for publication.
Furthermore, under the supervision of Vice President Koichi Izumikawa of Nagasaki University (responsible for COVID-19 countermeasures), a specific clinical study for administering 5-ALA to COVID-19 patients is being planned. This study was officially approved by the Clinical Research Ethical Review Board of Nagasaki University on October 28, 2020, and details will be published in the clinical research database later. This multi-center trial will be conducted in several hospitals, centered around Nagasaki University Hospital.
As COVID-19 continues to pose a global public health threat, the development of effective treatments remains a critical and urgent global issue. However, currently, only a few treatments are effective against COVID-19, and these are subject to patient symptoms and require careful monitoring, including potential side effects.
Meanwhile, vaccine development is being pursued by various domestic and international companies and research institutions, but it involves ensuring the efficacy and safety of the vaccines, confirming the ability to mass-produce them while maintaining quality, which takes years.
In the current situation where the end of the pandemic is not in sight, there is a desperate need for drugs that are safe, can be used widely across patients, and are readily available without supply concerns.
In this specific clinical study, NPJ will support the research conducted by Nagasaki University, leveraging our knowledge and technology related to 5-ALA. We hope that 5-ALA will become a new preventive and therapeutic option against COVID-19.
*1 Nagasaki University was established in 1949 and has since moved and consolidated its campuses. The Sakamoto campus houses the medical faculties and research institutes, including the School of Medicine, Dental School, Nagasaki University Hospital, and the Institute of Tropical Medicine. Nagasaki University is a leading institution in tropical medicine and infectious diseases, with a rich history and extensive research portfolio, making it a prominent educational and research center in Japan and internationally.
*2 NeoPharma Japan Co., Ltd. was established as a joint venture between Neopharma LLC based in the United Arab Emirates (UAE) and neo ALA Co., Ltd. (formerly Cosmo ALA Co., Ltd.). The NeoPharma Group is an international pharmaceutical company headquartered in the UAE, with a strong presence in the Middle East and emerging markets. NeoPharma Japan plays a critical role in the pharmaceutical manufacturing sector of Neopharma LLC’s global strategy. Additionally, by developing various applications of 5-ALA, NeoPharma Japan contributes added value to the entire group.
*3 5-ALA (5-aminolevulinic acid) is vital for the function of mitochondria, the cell organelles that produce energy necessary for life. 5-ALA ultimately converts into a substance called “heme” within the mitochondria, which is an essential component of cytochromes that generate energy. Heme also assists in transporting oxygen within red blood cells by binding to globin to form hemoglobin. The synthesis of 5-ALA, which has been used in health foods, cosmetics, pet supplements, fertilizers, and more for over a decade, was initially challenging but has been made possible through large-scale cultivation using photosynthetic bacteria.
*4 The paper has been submitted for peer review and may be subject to changes. However, the pre-peer review manuscript is available on the bioRxiv website at https://www.biorxiv.org/content/10.1101/2020.10.28.355305v1.
For inquiries, contact:
Professor Kiyoshi Kita, Dean of the School of Tropical Medicine and Global Health, Nagasaki University (1-12-4 Sakamoto, Nagasaki City) Tel: 095-819-7008 (General Affairs) Email: kitak@nagasaki-u.ac.jp
