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

Exscientia Business Update for First Quarter 202225.5.2022 22:01:00 CEST | Press release

Exscientia plc (Nasdaq: EXAI) This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220525005906/en/ Recent advancements in the Company’s pipeline, collaborations, and operations, as well as financial results for the first quarter 2022, are summarised below. In addition, Exscientia will host a conference call Thursday, May 26 at 1:30 p.m. BST / 8:30 a.m. ET to provide an overview of the Company's precision medicine platform. "We started 2022 by commencing a groundbreaking collaboration with Sanofi to develop a pipeline of AI-designed medicines utilising the breadth of our end-to-end platform of AI-driven capabilities from target prioritisation, to drug engineering and patient selection. At this year's American Association of Cancer Research (AACR) Annual Meeting, we highlighted our advancements in this area, including how AI-enabled drug design can help create drug candidates for challenging targets in oncology. In addition, we sho

ArborXR Announces Strategic Collaboration with Qualcomm Technologies, Helping Companies Scale VR and AR Deployments25.5.2022 19:37:00 CEST | Press release

ArborXR announced today the company will work with Qualcomm Technologies, Inc. on an extended reality (XR) mobile device management (MDM) platform to make it easier for companies to scale virtual reality (VR) and augmented (AR) headset deployments. By working closely with original equipment manufacturer (OEM) partners and direct enterprise clients, ArborXR and Qualcomm Technologies have identified key problems that still exist in scaling a fleet of XR headsets. Companies today looking to deploy a fleet of VR or AR devices face many challenges enrolling and provisioning headsets, managing them remotely, installing apps and updates, and controlling the user experience. To solve these problems, ArborXR will provide device management software to Qualcomm Technologies’ XR customers and OEMs with large-scale deployments for use with Qualcomm Technologies’ cutting edge VR/AR hardware available. OEMs will be able to pre-install ArborXR, and ArborXR’s software will support new VR and AR referen

L&T Technology Services inaugurates Engineering R&D Centre in Poland to provide Embedded and Digital Solutions to Clients25.5.2022 19:05:00 CEST | Press release

L&T Technology Services Limited (BSE: 540115, NSE: LTTS), a global leading pure-play engineering services company, today inaugurated its Engineering, Research and Development (ER&D) centre in Krakow, Poland, which will cater to global customers, leveraging cutting edge technologies in the Automotive, Mobility and Hi-Tech domains. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220525005835/en/ Seen in the picture (from right to left): Jagyan Mishra, Delivery Head (Europe) at LTTS, Abhishek Sinha, Chief Operating Officer and Member of the Board at LTTS, Mr. Jerzy Muzyk, Deputy Mayor of the City of Krakow, Her Excellency Nagma Mohamed Mallick, Ambassador of India to the Republic of Poland, Mr. Lukasz Słoniowski, President of the Board at Investor Support Krakow and Rajkumar Ravindranathan, Chief Business Officer at LTTS, during the inauguration of the ER&D centre. (Photo: Business Wire) The state-of-the-art centre will mark its

E-LAND Innople Chooses Rimini Street Support Services for SAP S/4 HANA25.5.2022 18:00:00 CEST | Press release

Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products, and a Salesforce partner, today announced that E-LAND Innople, an IT affiliate of the South Korean conglomerate E-Land Group, has chosen Rimini Street Support for SAP. The move has drastically cut E-LAND Innople’s annual maintenance costs and freed up budget to fuel new IT technology, digital transformation, and online expansion. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220525005081/en/ E-LAND Innople Chooses Rimini Street Support Services for SAP S/4 HANA (Graphic: Business Wire) Rimini Street Support Increases Business Agility E-LAND Innople provides IT solutions across various industries including fashion, distribution, hotels, restaurants, and construction. The company is responsible for the IT operations of E-Land Group, including ERP man

Agendia Achieves Historic Milestone of Enrolling 10,000 Patients in FLEX, the Largest-Ever Prospective, Real-World-Evidence Trial for Patients With Early Stage Breast Cancer25.5.2022 17:39:00 CEST | Press release

Agendia, Inc., a commercial-stage company focused on improving outcomes for breast cancer patients worldwide by providing physicians and patients with next-generation diagnostic and information solutions to inform optimized treatment decision-making, today announced 10,000 patients have been successfully enrolled in the FLEX Registry. Agendia’s unique FLEX Registry is a real-world, large-scale, prospective, observational breast cancer study (NCT03053193) intended to enable the discovery of novel genomic profiles to improve precision in the management of breast cancer. The FLEX Registry’s groundbreaking approach to cancer research is accelerating impactful data generation with its patient-centric design and national network of participating sites, allowing its investigator-initiated sub-studies to produce critical results that drive science forward. Six posters based on data from FLEX will be presented at ASCO 2022, one of which will be a poster discussion session. “When we developed th