Business Wire

New Data for Shionogi’s COVID-19 Once-Daily Oral Antiviral S-217622 Show Rapid Virus Clearance

Share

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 & Infectious Diseases (ECCMID) in Lisbon, 23 – 26 April. S-217622 is an investigational 3CL protease inhibitor that was studied for once-daily oral administration in mainly vaccinated patients (~85%), with no risk factors for severe complications, within five days of COVID-19 symptom onset.

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, Disease Control and Prevention Center, National Center for Global Health), which followed previously reported topline results from the Phase 2b study. These new data showed:

Antiviral effect:

  • S-217622 demonstrated rapid clearance of the infectious SARS-CoV-2 virus.
  • On day four of treatment (following the third dose), the proportion of patients with positive viral titer decreased by approximately 90% versus placebo.
  • S-217622 shortened infectious virus shedding by 1-2 days versus 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; under -1.0 logx copies/mL on day four at each dose).

Clinical symptom improvement:

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

Safety:

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

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

A second late-breaking presentation by Shionogi reported results from both the Phase 1 clinical trial and the Phase 2a part 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 demonstrated it was generally well-tolerated, and rapidly cleared SARS-CoV-2. The full abstracts and oral presentations are available on the ECCMID website.

“These results demonstrate 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 rise in areas worldwide, it is important we have access to a range of easily administered treatment options to ease the pressures on our healthcare systems,” said Isao Teshirogi, Ph.D., President and CEO at Shionogi & Co., Ltd. “We look forward to continued study of this antiviral in Phase 3 trials.”

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

###

About S-217622

S-217622, an investigational therapeutic drug for COVID-19, is an 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 utilizes an enzyme called 3CL protease that 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 trial (Phase 2a and 2b parts), 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 the placebo, and no serious safety concerns were reported. The Phase 3 part of the Phase 2/3 clinical trial is in progress. Additionally, in the preliminary in vitro study, S-217622 exhibited similar antiviral activity against the Omicron subvariant BA.2 and other existing variants. Recognizing the urgent global need for more therapies to address COVID-19, Shionogi has already begun working with worldwide health authorities including those located in Japan, where it filed for manufacture and sales approval on February 25, 2022, as well as in the United States.

Shionogi’s commitment to fight COVID-19

With continued social disruption caused by the worldwide spread of the novel 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 major focus on infectious diseases, Shionogi is also working with public institutions, academia, and partner companies to address COVID-19, by pursuing the discovery of novel therapeutics and the development of vaccine and diagnostic products. We will continue to strive to fulfil our social responsibility and to contribute to re-establishing the safety and security of society by bringing forward new tools and technologies for the diagnosis and treatment of COVID-19 to support ending this pandemic. Shionogi will work closely with government, industry, and academia to accelerate our efforts and will keep all stakeholders informed regarding 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 “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company has discovered and developed novel medicines for 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 the focus of the company’s pipeline include CNS/psychoneurological diseases, oncology and pain. For more information on Shionogi & Co., Ltd., visit https://www.shionogi.com/global/en/. Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd. based in N.J. For more information on Shionogi Inc., please visit https://www.shionogi.com. Shionogi B.V. is the European headquarters of Shionogi & Co., Ltd. For more information on Shionogi B.V., please visit www.shionogi.eu.

Forward Looking Statement

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which 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 of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of 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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Corporate Communications, Shionogi & Co., Ltd. (HQ)
https://www.shionogi.com/global/en/contact.html

For S-217622 Shionogi US and European media relations:
Elizabeth Adelanwa, Weber Shandwick (agency partner)
EAdelanwa@webershandwick.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

H.I.G. Capital Announces the Sale of DGS S.p.A.11.6.2024 12:00:00 CEST | Press release

H.I.G. Capital (“H.I.G.”), a leading global alternative investment firm with $62 billion of capital under management, is pleased to announce that an affiliate has signed a definitive agreement to sell its portfolio company, DGS S.p.A. (“DGS” or the “Group”), a leading firm in the Italian Information Technology market, to DGS Co-Founders and management team in partnership with ICG, a global alternative asset manager. Since its inception in 1997, DGShas supported blue-chip customers in the design, integration, and maintenance of complex IT systems, with a specialization in digital transformation and cybersecurity services. The Group currently has over 1,900 employees, revenues of approximately €300 million, and maintains a group of highly loyal clientele. During H.I.G.’s ownership, DGS has tripled in size and consolidated its position as a leading Italian firm in cybersecurity services and digital transformation. DGS offers its clients sophisticated and proprietary digital transformation

Evertas Names Nick Selby Head of European Underwriting11.6.2024 12:00:00 CEST | Press release

Evertas, the world’s first crypto insurance company, has named Nick Selby as its new Head of European Underwriting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611141887/en/ Nick Selby, Executive Vice President and Head of European Underwriting at Evertas (Photo: Business Wire) Selby, an accomplished information and physical security professional, brings two decades of expertise in public and private sector information security, physical security, and complex incident handling, as well as seven years of experience leading teams securing billions of dollars in cryptoassets. Previously, his roles included VP of the Software Assurance Practice at Trail of Bits, Chief Security Officer at Paxos Trust Company, and Director of Cyber Intelligence and Investigations at the NYPD Intelligence Bureau. “Nick is an extremely valuable addition to our European team,” said Evertas CEO and Co-Founder J. Gdanski. “His public and private

Owlet utvider globalt fotavtrykk med lanseringen av medisinsk-sertifisert Dream Sock™ i Storbritannia og over hele Europa11.6.2024 11:00:00 CEST | Pressemelding

Owlet, Inc. («Owlet» or the «Company») (NYSE:OWLT), pioneren innen smart spedbarnsovervåking, kunngjør i dag den britiske og europeiske lanseringen av Dream Sock. Dette er en smart babymonitor med levende helseavlesninger og varsler for friske spedbarn mellom 0-18 måneder og 2,5-13,6 kg. Dette innovative medisinske utstyret gir foreldre helse og viktig informasjon i sanntid, noe som gir uovertruffen trygghet. Denne pressemeldingen inneholder multimedia. Se hele pressemeldingen her: https://www.businesswire.com/news/home/20240611820341/no/ (Photo: Business Wire) «Vi er svært stolte over å lansere Dream Sock til omsorgspersoner over hele Storbritannia og Europa og gi millioner av foreldre mer trygghet mens babyen sover,» sa Kurt Workman, Owlets administrerende direktør og medgründer. «Dream Sock er nå et globalt produkt som er anerkjent som medisinsk nøyaktig og trygt, etter å ha gjennomgått regulatoriske autorisasjoner og sertifiseringer innenfor flere geografier. I dag er misjonen vår

V-Nova Surpasses 1000 Patent Milestone in Media Technology Innovation11.6.2024 10:00:00 CEST | Press release

V-Nova, a leading provider of data compression solutions, video compression technology, XR technology, AI acceleration and parallel processing for a multitude of industries including media and entertainment, today announced its milestone achievement of 1000 active technology patents. This accomplishment underscores V-Nova’s dedication to research and development and its commitment to protecting its intellectual property globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611724561/en/ V-Nova’s patent portfolio spans more than 50 different jurisdictions. Including over 400 patents in Europe, over 200 in the Americas, over 100 in the United States specifically, and over 200 in Asia. V-Nova forged new directions in data processing to enhance digital experiences, maximize efficiency, reduce costs, and increase sustainability. The company leads the way with key international data compression standards for the video indust

Alipay+ Reveals Top Scorer Trophy Design for UEFA EURO 2024™11.6.2024 09:24:00 CEST | Press release

Alipay+, a suite of cross-border mobile payment and digitalization technology solutions operated by Ant International and an Official Partner of UEFA EURO 2024™, today revealed the trophy that will be awarded to the most prolific marksman at the UEFA EURO 2024™ finale on July 14 in Berlin, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240610328619/en/ The UEFA Top Scorer Trophy presented by Alipay+ is unveiled for UEFA EURO 2024™ (Photo: Business Wire) Sculpted in the shape of the Chinese character “支” (pronounced zhi, and meaning payment as well as support), the trophy reflects Alipay+’s dedication to supporting consumers to enjoy seamless payment and a broad choice of deals using their preferred payment methods while traveling abroad. The character also resembles the fleeting moment of a barefooted striker poised to shoot, evoking the original beauty and power of football – a game that united people across the wo

World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye