Shionogi has entered into a licensing agreement with BioAge Labs, Inc. (hereinafter «BioAge») to develop an apiprant (S-555739) to control the exacerbation of COVID-19. The asapiprant is a DP1 receptor antagonist discovered by Shionogi. In a clinical trial conducted by BioAge, administration of asapiprant significantly reduced mortality and viral load in the lungs in older mice infected with SARS-CoV-2. Several non-clinical studies and clinical trials in more than 2,400 subjects have shown that the asapprant has a high affinity and selectivity for the DP1 receptor and is well tolerated and safe. We will continue to work with relevant ministries and agencies to promote initiatives for the rapid administration of Japanese vaccines. Shionogi has discovered an oral antiviral small molecule (S-217622) that is a 3CL protease inhibitor that selectively inhibits the enzyme essential to the virus through intensive joint research with Hokkaido University`s Research Center for Zoonosis Control. S-217622 has been shown to rapidly and significantly reduce viral load in non-clinical trials involving sars-CoV-2 infected animals. In a Japanese Phase 1 clinical trial that began in July 2021, we confirmed tolerability and no major safety issues at this time, and pharmacokinetic analyses confirm that blood concentrations of drugs are reached that meet or exceed the target concentration.
Based on this study result, a Phase 2/3 clinical trial was initiated on September 27, 2021. The Phase 2/3 clinical trial will evaluate the efficacy and safety of oral administration of this drug once daily for 5 days in patients with mild COVID-19 or asymptomatic infection compared to PLACEBO versus placebo. Since November 9, 2021, the number of people infected with SARS-CoV-2 in Japan continues to decline, so we encourage the deployment of facilities abroad to accelerate the recruitment of clinical trial participants. The candidate countries are South Korea, Singapore, Vietnam, the United Kingdom, etc., and adjustments are underway. As far as the supply system is concerned, we are making good progress in completing preparations for national delivery by 2021. We will continue to work with relevant ministries and authorities to promote initiatives to rapidly deploy S-217622. We are also in discussions with foreign regulators such as the FDA and EMA on global development. Partnerships for global expansion are currently being negotiated with several companies with a view to reaching an agreement by 2021. OSAKA, Japan, January 26, 2021 — Shionogi & Co., Ltd. (Headquarters: Osaka, Japan; President and Chief Executive Officer: Isao Teshirogi, Ph.D. («Shionogi») announced today that Shionogi has entered into a licensing agreement with BioAge Labs, Inc.
(Headquarters: Richmond, California, USA; CEO: Kristen Fortney, Ph.D., «BioAge») to grant BioAge exclusive development and commercialization rights in the United States and Europe for S-555739 (prostaglandin D2 DP1 receptor antagonist, BioAge code: BGE-175) to control the exacerbation of COVID-19. 23. Press release of 11. June 2021 Announcement of an exclusive licensing agreement for a method of detecting viruses susceptible to viruses and bacteria, including the novel coronavirus, between Hokkaido University and SHIONOGI Shionogi & Co., Ltd. is a leading research-driven pharmaceutical company dedicated to providing benefits to patients, based on its corporate philosophy of «providing the best possible medicine to protect the health and well-being of patients that we serve.» Shionogi`s research and development currently focuses on two therapeutic areas: infectious diseases and pain and CNS disorders. For more than 50 years, Shionogi has been developing and marketing innovative oral and parenteral anti-infectives. In addition, Shionogi deals with new areas of research such as obesity/geriatric metabolic diseases and oncology/immunology. Contributing to the health and quality of life of patients around the world through development in these therapeutic areas is Shionogi`s main goal.
For more information, see www.shionogi.co.jp/en/. Based on our licensing agreement for a novel method for rapid diagnosis of viral infections, including the novel coronavirus, with Nihon University, Gunma University and Tokyo Medical University, Shionogi continues to develop a novel method for rapid diagnosis of COVID-19 using an innovative nucleic acid amplification technique, the SATIC method (Signal amplification by ternary initiation complexes). On the other hand, given the balance of other testing methods such as PCR and antigen testing, we have stopped our efforts to commercialize the SATIC method for COVID-19. Basic research will continue in the scientific field and we will continue to hold the license right for the SATIC method. Japanese pharmaceutical company Shionogi & Co() and California-based BioAge Labs have entered into a licensing agreement granting BioAge exclusive rights to develop and commercialize the COVID-19 drug S-555739 in the United States and Europe, Shionogi said in a filing Tuesday. Shionogi is committed to «protecting people around the world from the threat of infectious diseases.» We do not limit ourselves to the research and development of therapies, but also pursue the comprehensive management of infectious diseases through awareness, prevention, diagnosis and treatment of exacerbations, as well as the treatment of the infection itself. As a leader in the fight against infectious diseases, we are working to develop new drugs and vaccines and maximize the value of existing compounds to help restore social security by prematurely ending COVID-19. In addition, we will intensify our efforts, including working with external partners to provide healthcare solutions to more patients. Shionogi has also granted BioAge exclusive rights to negotiate a license for additional indications for the treatment of COVID-19, according to the filing. Shionogi had signed a basic agreement with Shimadzu Corporation for a business alliance for wastewater monitoring in the field of infectious diseases, including SARS-CoV-2. Based on this agreement, Shimadzu and Shionogi will continue discussions on the creation of a consortium for the early social implementation of wastewater monitoring and the establishment of a pan-Japan system.
Shionogi entered into a joint sales agreement with Towns Co., Ltd. for antigen test kits for the novel coronavirus (SARS-CoV-2), and on November 29, Shionogi began the joint sale of «Immunoace ® SARS-CoV-2 II». This kit can easily achieve results in a short time of about 15 minutes with a nasopharyngeal smear or nasal swab. In the future, the two companies will also promote an antigen test kit capable of simultaneously detecting SARS-CoV-2 and influenza, which Towns has currently submitted for approval. Shionogi will offer products that meet the needs of medical institutions and patients. S-555739 or prostaglandin D2 DP1 receptor antagonist was discovered by Shionogi and was in development for the treatment of allergic rhinitis, depending on the application. Age-related declines in immune function are known to be important risk factors that increase morbidity and mortality from infectious diseases2. Therefore, it has been suggested that restoring immune function could reduce the severity of various infectious diseases, including COVID-19.
The DP1 receptor was identified in an original AI-based analysis of longitudinal omics data in humans conducted by BioAge as a drug discovery target that improves age-related declines in immune function. In addition, in one at the University of Iowa by Dr. Stanley Perlman`s study, in which an existing DP1 receptor antagonist was administered in an elderly mouse model of SARS coronavirus infection (SARS-CoV), improved the mortality rate of mice and observed a significant decrease in viral load in the lungs3. . . .