New data for Shionogis COVID-19 once daily oral antiviral agent S-217622 show rapid virus eradication
New data for Shionogis COVID-19 once daily oral antiviral agent S-217622 show rapid virus eradication

New data for Shionogis COVID-19 once daily oral antiviral agent S-217622 show rapid virus eradication

OSAKA, Japan – () – Shionogi & Co., Ltd. (hereinafter “Shionogi”) today announced new results from two late presentations of S-217622 on the 32nd.nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Lisbon, 23-26 April. S-217622 is a 3CL protease inhibitor that was tested for oral administration once daily in mainly vaccinated patients (~ 85%), with no risk factors for serious complications, within five days after the onset of COVID-19 symptoms.

At the meeting, Shionogi presented new late Phase 2b results from Phase 2/3 clinical trials with S-217622, ​​completed in Asia (speaker: Norio Ohmagari, Disease Control and Prevention Center, National Center for Global Health), which followed previously reported topline results from the phase 2b study. This new data showed:

Antiviral effect:

  • S-217622 demonstrated rapid clearance of the infectious SARS-CoV-2 virus.

  • On day four of treatment (after the third dose), the proportion of patients with positive viral titer decreased by approx. 90% compared to placebo.

  • S-217622 shortened the excretion of infectious virus by 1-2 days compared to placebo.

  • S-217622 showed a significant reduction in viral RNA on days 2, 4, 6 and 9 versus placebo (difference versus placebo in the least squares mean change from baseline in viral RNA; below -1.0 logx copies / ml on day four at each dose).

Clinical symptom improvement:

  • There was no significant difference in the overall score of 12 COVID-19 symptoms between treatment arms, but S-217622 showed improvement in composite score of five “respiratory and feverish” symptoms (post-hoc analysis).

Security:

  • Both the Phase 1 and 2a / b portions of the Phase 2/3 clinical trials showed that S-217622 was well tolerated, with few drug discontinuations, and no reports of serious adverse events or death. Treatment-induced adverse reactions in these studies were generally mild to moderate and resolved without treatment.

The Phase 2b study was performed with 428 patients in Japan and South Korea. Its main purpose was to confirm the antiviral effect and clinical improvement of S-217622 when administered orally once daily for five days, versus placebo.

Another late-breaking presentation by Shionogi reported results from both the Phase 1 clinical trial and the Phase 2a portion of the Phase 2/3 clinical trial of S-217622 completed in Japan (speaker: Hiroshi Yotsuyanagi, The Institute of Medical Science, The Institute of Medical Science, The University of Tokyo), which showed that it was generally well tolerated, and quickly cleared SARS-CoV-2. The full abstracts and oral presentations are available at ECCMID website.

These results show that S-217622 rapidly eliminates SARS-CoV-2 in patients versus placebo, marking its potential, if approved, as an effective treatment option for COVID-19. As infections continue to increase in areas worldwide , it is important that we have access to a range of easily managed treatment options to ease the pressure on our healthcare systems, ”said Isao Teshirogi, Ph.D., President and CEO of Shionogi & Co., Ltd.” We look forward to further research of this antiviral agent in phase 3 trials. ”

A separate Global Phase 3 study of S-217622 is underway, with the aim of recruiting participants globally to support regulatory applications this year.

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About S-217622

S-217622, ​​a therapeutic experimental drug against COVID-19, is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 uses an enzyme called 3CL protease, which is essential for the replication of the virus. S-217622 suppresses the replication of SARS-CoV-2 by selectively inhibiting 3CL protease.

In the Phase 2 study (Phase 2a and 2b sections), completed in Japan and Korea, patients treated with S-217622 showed a significant and rapid decrease in viral titer and / or viral RNA on day 4 (after day 3).rd dose) compared to placebo and no serious safety concerns were reported. The Phase 3 part of the clinical Phase 2/3 study is underway. In addition, in the preliminary in vitro study, S-217622 showed similar antiviral activity against the Omicron subvariant BA.2 and other existing variants. Recognizing the urgent global need for more treatments to address COVID-19, Shionogi has already begun working with worldwide health authorities, including those located in Japan, where it applied for manufacturing and marketing approval on February 25, 2022, as well as in the United States.

Shionogi’s commitment to combat COVID-19

With continued social disruption caused by the worldwide spread of the new coronavirus (SARS-CoV-2), Shionogi continues intensive efforts to deliver pharmaceutical products to patients in need in a reliable and stable manner. As a pharmaceutical company with a strong focus on infectious diseases, Shionogi also works with public institutions, academia and partner companies to address COVID-19 by pursuing the discovery of new therapeutic agents and the development of vaccine and diagnostic products. We will continue to strive to live up to our social responsibility and help re-establish the safety and security of society by introducing new tools and technologies for the diagnosis and treatment of COVID-19 to support an end to this pandemic. Shionogi will work closely with government, industry and academia to accelerate our efforts and will keep all stakeholders informed of the progress of our efforts.

About Shionogi

Shionogi & Co., Ltd. is a leading global research-driven pharmaceutical company based in Japan, dedicated to bringing benefits to patients based on its corporate philosophy of “providing the best possible medicine to protect the health and well-being of the patients we serve.” The company has discovered and developed new drugs for HIV, influenza and antimicrobial resistance and currently markets products in several therapeutic areas, including anti-infective drugs with the first siderophoric cephalosporin, cefiderocol.Other therapeutic areas and focus in the company’s pipeline include CNS / psychoneurological diseases, oncology and pain. more information about Shionogi & Co., Ltd., visit https://www.shionogi.com/global/en/. Shionogi Inc. is the US subsidiary of Shionogi & Co., Ltd. based in NJ For more information on Shionogi Inc., please visit https://www.shionogi.com. Shionogi BV is the European headquarters of Shionogi & Co., Ltd. For more information about Shionogi BV, please visit www.shionogi.eu.

Forward-looking statement

This announcement contains forward-looking statements. These statements are based on expectations in the light of the information currently available, assumptions that are subject to risks and uncertainties that may cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industrial and market conditions as well as changes in interest rates and exchange rates. These risks and uncertainties apply in particular to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, the completion and discontinuation of clinical trials; obtain regulatory approvals; claims and concerns about the safety and effectiveness of the product; technological advances; negative outcome of important litigation; domestic and foreign health reforms and amendments to laws and regulations. For existing products, there are also production and marketing risks, which include, but are not limited to, the inability to build production capacity to meet demand, unavailability of raw materials and access to competitive products. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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