New Data on Shionogi’s S-217622 Once-Daily Oral Antiviral Shows Rapid Virus Clearance | News

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OSAKA, Japan–(BUSINESS WIRE)–April 23, 2022–

Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced new results from two late-breaking presentations of S-217622 at the 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Lisbon, April 23-26. S-217622 is an investigational 3CL protease inhibitor that has been studied for once-daily oral administration in predominantly vaccinated patients (~85%), with no risk factors for serious complications, within five days of administration. onset of symptoms of COVID-19.

At the meeting, Shionogi presented new late-breaking Phase 2b results from the Phase 2/3 clinical trial of S-217622, ​​completed in Asia (presenter: Norio Ohmagari, Center for Disease Control and Prevention). diseases, National Center for Global Health), which followed the first results of the phase 2b study have already been published. These new data showed:

Antiviral effect:

  • S-217622 demonstrated rapid clearance of infectious SARS-CoV-2 virus.
  • On the fourth day of treatment (after the third dose), the proportion of patients with a positive viral titer decreased by approximately 90% compared to placebo.
  • S-217622 shortened infectious virus shedding by 1-2 days compared to placebo.
  • S-217622 showed a significant reduction in viral RNA on days 2, 4, 6 and 9 compared to placebo (difference from placebo in least squares mean change from baseline in RNA viral; less than -1.0 log x copies/mL on day four at each dose).

Improvement of clinical symptoms:

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

Security:

  • Phase 1 and 2a/b of Phase 2/3 clinical trials have shown S-217622 to be well tolerated, with few drug-related discontinuations and no reports of serious adverse events or deaths. Treatment-emergent adverse events in these trials were generally mild to moderate and resolved without treatment.

The phase 2b study was conducted in 428 patients in Japan and South Korea. Its primary objective was to confirm the antiviral effect and improvement in clinical symptoms of S-217622 when administered orally once daily for five days, compared to placebo.

A second late-breaking presentation by Shionogi reported on the results of the phase 1 clinical trial and phase 2a of the phase 2/3 clinical trial of S-217622 completed in Japan (presenter: Hiroshi Yotsuyanagi, The Institute of Medical Science, The University of Tokyo), which has been shown to be generally well tolerated and rapidly cleared SARS-CoV-2. Full abstracts and oral presentations are available on the ECCMID website.

“These results demonstrate that S-217622 rapidly clears SARS-CoV-2 in patients compared to placebo, marking its potential, if approved, as an effective treatment option for COVID-19. As infections continue to rise in regions around the world, it is important that we have access to a range of easy-to-administer treatment options to ease pressures on our healthcare systems,” said Isao Teshirogi, Ph. .D., President and CEO of Shionogi & Co., Ltd. “We look forward to further study of this antiviral in phase 3 trials.”

A separate global Phase 3 study of S-217622 is underway, aiming to recruit participants worldwide to support regulatory filings this year.

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About S-217622

S-217622, ​​an investigational therapeutic drug for 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 virus replication. S-217622 suppresses SARS-CoV-2 replication by selectively inhibiting the 3CL protease.

In the Phase 2 trial (Phases 2a and 2b), 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 the 3rd dose) compared to placebo, and no serious safety issues were reported. Phase 3 of the Phase 2/3 clinical trial is ongoing. Moreover, in the draft in vitro study, S-217622 exhibited similar antiviral activity against the Omicron BA.2 subvariant and other existing variants. Recognizing the urgent global need for more therapies to combat COVID-19, Shionogi has already begun working with global health authorities, including those located in Japan, where it has applied for manufacturing and sales approval. on February 25, 2022, as well as in the United States. .

Shionogi’s commitment to the fight against COVID-19

With the continued social disruptions caused by the global spread of the novel coronavirus (SARS-CoV-2), Shionogi continues its intensive efforts to provide pharmaceuticals to patients in need in a reliable and stable manner. As an infectious disease pharmaceutical company, Shionogi is also working with public institutions, universities and corporate partners to fight COVID-19, pursuing the discovery of new therapies and the development of vaccines and diagnostics. . We will continue to strive to fulfill our social responsibility and contribute to the restoration of the safety and security of society by providing new tools and technologies for the diagnosis and treatment of COVID-19 to support the end of 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 research-driven, Japan-based global pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of “providing the best possible medicine to protect health and well-being”. -be the patients we serve. “The company has discovered and developed new drugs against HIV, influenza and antimicrobial resistance, and currently markets products in several therapeutic areas including anti-infectives with the first siderophore cephalosporin, cefiderocol. Other therapeutic areas and pipeline focus of the Company include CNS/psychoneurological diseases, oncology and pain. For 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 New Jersey. For more information about 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 light of currently available information, assumptions that are subject to risks and uncertainties that could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes in interest rates and exchange rates. These risks and uncertainties apply particularly to forward-looking statements relating to products. Product risks and uncertainties include, but are not limited to, the completion and interruption of clinical trials; obtain regulatory approvals; product safety and efficacy claims and concerns; technological advances; the adverse outcome of material litigation; domestic and foreign health care reforms and changes in laws and regulations. Additionally, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, the inability to expand production capacity to meet demand, unavailability of raw materials and entry of competing 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.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20220423005001/en/

CONTACT: Corporate Communications, Shionogi & Co., Ltd. (seat)

https://www.shionogi.com/global/en/contact.html

For US and European Media Relations of S-217622 Shionogi:

Elizabeth Adelanwa, Weber Shandwick (agency partner)

EAdelanwa@webershandwick.com

KEYWORD: JAPAN ASIA PACIFIC

INDUSTRY KEYWORD: HEALTH INFECTIOUS DISEASES CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICALS BIOTECHNOLOGY

SOURCE: Shionogi USA

Copyright BusinessWire 2022.

PUBLISHED: 04/23/2022 11:15 AM/DISC: 04/23/2022 11:17 AM

http://www.businesswire.com/news/home/20220423005001/en

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