Notice Regarding Joint Study Using Dietary Supplement Containing 5-Aminolevulinate Phosphate and Sodium Ferrite Citrate in Patients with Coronavirus Infection (COVID-19)

Photonamic GmbH & Co. KG (Headquarters: Pinneberg, Germany, Representative: Ulrich Kosciessa, Ph.D. , SBI Pharma Co., Ltd. (Headquarters: Minato-ku, Tokyo, President: Yoshitaka Kitao), which conducts research and development of pharmaceuticals, health foods and cosmetics using 5-ALA with “Photonamic”) , SBI Pharma) provides research funding and test meals, respectively, and is sponsored by the Royal Irish Academy of Surgical Medicine, Bahrain Medical University (Location: Bahrain, hereafter “RCSI Bahrain”), a new type of coronavirus infection (COVID-). 19) A study using 5-ALA phosphate and sodium ferrous citrate (SFC) -containing dietary supplements in patients “5-aminolevulinic acid phosphate + ferrous citrate in COVID-19 subjects” RCSI Burlane has completed the first phase of clinical trials for a pilot study to evaluate the safety, tolerability, and efficacy of sodium (ClinicalTrials.gov identification number: NCT04542850, hereinafter referred to as the “final study”) We are pleased to inform you that we have announced.

The following materials are Japanese translations of the press release released by RCSI Bahrain on March 11, and are provided as reference materials. Please refer to the English press release (Title: First Stage of Joint Research between RCSI Bahrain and BDF of a Food Supplement Known in Modulation of Antiviral Effects in COVID-19 Patients Completed) for its contents and interpretation.

The first phase of a joint RCSI-BDF study to evaluate the tolerability, safety, and efficacy of dietary supplements known for their regulation of antiviral effects in COVID-19 patients has been completed.

March 11: Royal College of Surgeons, Bahrain Medical College (RCSI Bahrain), as part of its ongoing research efforts, the safety of using 5-ALA phosphate and SFC-containing dietary supplements for COVID-19 patients, Shinobi Intervention study to evaluate tolerability and efficacy A pilot study to evaluate the safety, tolerability, and efficacy of 5-aminolevulinic acid phosphate + sodium ferrous citrate in COVID-19 subjects. (Hereinafter referred to as “this test”).

The study is led by Professor John Flood, Dean and Professor of Medicine, in collaboration with the Bahrain Defense Force Hospital (BDF), the testing facility, with the support of Professor Stephen Atkin, Dean of the Graduate School of RCSI Bahrain. With the cooperation of SBI ALApharma’s subsidiary Photonamic Co., Ltd. and SBI Pharmaceuticals through the provision of research funds and test meals, this study will be conducted by BDF histopathologist Brigadier General Abdullah Darwish, Ph.D. It is carried out by a specialist doctor, Dr. Abdul Rahman Hassan al-Madani, as a research coordinator. The study has been approved by the Clinical Research Committee of the National Hot Rod Association (NHRA) in Bahrain.

Dr. Ulrich Kosiessa, CEO of Photonamic, explains: “5-ALA is a natural product produced by the mitochondria of various living cells. 5-ALA, along with iron, is a precursor to heme, which plays an important role in enhancing mitochondrial function and also produces hemoglobin. . 5-ALA phosphate is compounded with the iron preparation SFC and is sold as a nutritional supplement in Japan and other countries, and its safety has been confirmed. Many researchers have other indications and uses. We are in the process of testing for 5-ALA. ”In addition, Dr. Kosiessa adds: “5-ALA / SFC induces heme oxygenase-1 (HO-1) (1). HO-1 is an important enzyme in heme metabolism and many such as influenza, HIV, deer, Ebola and dengue. It is also involved in the regulation of the antiviral effect of the virus (2-6). Furthermore, in recent studies in Japan, 5-ALA phosphate is the cause of COVID-19, SARS-CoV- It has been reported to inhibit the infection of 2 and has an antiviral effect in human and non-human cells without showing significant cytotoxicity (7). 5-ALA phosphate / SFC. Was also safely administered to COVID-19 patients and had a positive effect on time to recovery (8). ”

In the first phase of the study, administration to 7 COVID-19 patients was completed, no associated adverse events were reported, suggesting good safety, and dietary experience with 5-ALA phosphate / SFC. And confirmed the safety profile so far based on the research. Based on these results, NHRA approved the continuation of the study, and enrollment of 33 patients with moderate and / or severe symptoms with COVID 19 was started, and 5-ALA phosphate / in addition to the current standard treatment. The tolerability, safety, and efficacy of SFC administration will continue to be investigated.

Professor Samia Otom, President of RCSI Bahrain, said: “RCSI Bahrain is committed to establishing a national research program and has played an important role in facilitating and accelerating research on COVID-19 therapy in Bahrain. Through the holding of the scientific symposium, we have collaborated with SBI ALApharma and its subsidiaries, especially Dr. Riad Lehani, director of the SBI Pharma Bahrain office. These joint projects show the significance and promising results of cooperation between the pharmaceutical industry and research programs. It highlights that it allows you to test existing beneficial drug treatments that help people with the disease recover in a controlled environment with regulatory approval. ”RCSI Bahrain About RCSI Bahrain is a constituent university of RCSI, founded in 1784 in Dublin, Ireland. As an independent private university, it opened its doors to 28 medical students in 2004. As a non-profit health science institution, RCSI Bahrain focuses on education and research to drive positive change in all areas of human health around the world. Currently, there are more than 1,300 students on the dedicated campus, including the Faculty of Medicine, the Faculty of Nursing, the Faculty of Midwifery, and the Graduate School of Graduate School. For more information, please visit www.rcsi.com/bahrain .

(1) https://pubmed.ncbi.nlm.nih.gov/29753693/

(2) https://www.jimmunol.org/content/176/7/4252

(3) https://pubmed.ncbi.nlm.nih.gov/30786886/

(4) https://pubmed.ncbi.nlm.nih.gov/24109237/

(5) https://virologyj.biomedcentral.com/articles/10.1186/s12985-019-1125-9

(6) https://pubmed.ncbi.nlm.nih.gov/27553177/

(7) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7846235/

(8) https://osf.io/azxsm/

Journal Abstract: https://www.sbipharma.co.jp/news/release/20210329/

For inquiries regarding this press release:

SBI Pharma Co., Ltd.: info_ala@sbigroup.co.jp

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