ACTG and Shionogi Announce Progress of Global Phase 3 Trial of Novel COVID-19 Oral Antiviral Agent S-217622

LOS ANGELES and OSAKA, Japan–(BUSINESS WIRE)–The AIDS Clinical Trials Group (ACTG), the world’s largest HIV research network that has expanded its focus to include evaluating outpatient COVID-19 treatments, and Shionogi & Co., Ltd., a global pharmaceutical company headquartered in Osaka, Japan with a long-standing commitment to the research and development of innovative, high-quality infectious disease medicines, today announced progress towards the launch of ACTIV-2d (also known as SCORPIO-HR), a global multicenter Phase 3 trial to evaluate the safety and efficacy of the COVID-19 antiviral agent S-217622. SCORPIO-HR will evaluate investigational 3CL protease inhibitor S-217622 as an oral once-daily treatment for high-risk non-hospitalized adults with COVID-19 within five days of symptom onset. The trial is being conducted by ACTG, sponsored by Shionogi and funded by the National Institute of Allergy and Infectious Diseases (NIAID) which is part of the National Institutes of Health (NIH).

SCORPIO-HR is a Phase 3, multicenter, randomized, double-blind, 48-week study that will evaluate the safety and efficacy of S-217622 in participants who tested positive for SARS-CoV-2 in outpatient, began to experience symptoms within five days of enrollment and have one or more risk factors that make them more likely to progress to a severe form of COVID-19. The United States Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) for S-217622, ​​allowing SCORPIO-HR to proceed. This trial follows favorable and positive results from phase 2a and phase 2b clinical trials (primarily conducted in Japan and used for submission to the Japanese health authority) that demonstrated proof of concept with significant antiviral activity and rapid cessation of infectious virus shedding.

“Although S-217622 is in the same class of treatments as oral medications currently available through emergency use authorizations to treat COVID-19, it is administered without a booster and only once daily. which can simplify treatment,” said Annie Luetkemeyer. , MD, University of California, San Francisco and Principal Investigator of S-217622. “We need more well-tolerated and highly effective options for treating COVID-19 that reduce the risk of serious complications and the duration of infectiousness. Based on preliminary clinical trial data, we are excited about the potential of S-217622 to be an important addition to our COVID-19 treatment toolkit.

SCORPIO-HR will be conducted with test sites in countries in Europe, South America, North America, Africa and Asia. Approximately 1,700 participants will be randomized in a 2:1 ratio so that two-thirds receive S-217622 and one-third receive placebo. Participants may receive locally provided COVID-19 treatment after registration, as long as it is compatible with S-217622.

“As more people begin to return to their daily lives, there remains a clear need for effective antiviral treatments for COVID-19 that can provide additional protection against serious illness and reduce the burden of COVID-19 on our lives. health systems,” Isao said. Teshirogi, Ph.D., President and CEO of Shionogi & Co., Ltd. date of infectious virus titer and rapid cessation of infectious virus shedding. We appreciate the collaboration and support of the NIH and ACTG on this investigational antiviral to bring new treatment options to a wide range of COVID-19 patients, and especially high-risk populations.

SCORPIO-HR is led by Kara W. Chew, MD, MS, University of California, Los Angeles (UCLA), Dr. Luetkemeyer, and Davey Smith, MD, University of California, San Diego (protocol co-chairs) and David Alain Wohl, MD, University of North Carolina (UNC) and Eric S. Daar, MD, Lundquist Institute at Harbor-UCLA Medical Center (vice chairs), and is supported by Judith Currier, MD, M.Sc., UCLA (ACTG chair ) and Joseph J. Eron, MD, UNC, (ACTG co-chair).

About S-217622

S-217622, ​​a 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 Phase 2 of a Phase 2/3 clinical trial conducted 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 3rd dose), compared to placebo. In Phase 2 of the Phase 2/3 clinical trial, no serious safety issues were reported. 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 and the United States. SCORPIO-HR is a global Phase 3 trial of the NIH-funded ACTIV-2 outpatient treatment study to SGarnish COVID-19pRogression with beginning Protase Ito preventOr treatment.

About ACTIV-2

ACTIV-2 is sponsored by NIAID, part of NIH, which also funds ACTG. ACTIV-2 is part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, a public-private partnership program established to create a coordinated research strategy that prioritizes and accelerates the development of treatments and vaccines. most promising vaccines. It also receives support from Federal COVID Response-Therapeutics, the U.S. government’s multi-agency effort to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapies, and diagnostics.

About ACTG

Founded in 1987, the AIDS Clinical Trials Group (ACTG) was the world’s first HIV research network. The ACTG carries out innovative studies to improve the treatment of HIV and its complications, in particular tuberculosis and viral hepatitis; reduce new HIV infections and illnesses; and advancing new approaches to prevent, treat and ultimately cure HIV in adults and children. More recently, the ACTG has expanded its scope to include the evaluation of outpatient treatments for COVID-19. ACTG investigators and research units in 15 countries are major resources for HIV/AIDS research, treatment, care and training/education in their communities. ACTG studies have helped establish current paradigms for the management of HIV infection and have informed HIV treatment guidelines, resulting in a dramatic decrease in HIV-related mortality worldwide.

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 commercializes products in several therapeutic areas including anti-infectives with the first siderophore cephalosporin, FETROJA® (cefiderocol; known as FETCROJA® in Europe). 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.

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 keep all stakeholders informed of the progress of our efforts.

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 particularly apply 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.

# # #

About Bradley J. Bridges

Check Also

Researchers win $4.2 million NIH grant to improve PrEP access and use in the Bronx

Bronx County has the fifth highest rate of HIV diagnosis in the nation, but the …