Cefiderocol Sulfate Tosylate

CAMBRIDGE, MA AND ALBANY, NY / ACCESSWIRE / November 19, 2024 / Next Gen Diagnostics (NGD), a world leader in the development of validated machine learning models for whole genome sequence- (WGS-) based determination of bacterial susceptibility to antibiotics, and the Wadsworth Center, New York State Department of Health's public health laboratory, today announce an agreement providing for Wadsworth to join the NGD Cefiderocol Data Consortium, as NGD develops a sequence-based diagnostic tool to help determine resistance to cefiderocol, the first novel antibiotic in 30 years, developed by the 150-year-old Japanese pharmaceutical company Shionogi."NGD's recently announced agreement with Shionogi is aimed at development of WGS-based cefiderocol prediction, a challenge of wide societal importance," remarks Dr. Kimberlee Musser, Chief of Bacterial Diseases at the Wadsworth Center. "In New York, we have far too many carbapenem-resistant infections, and that problem is getting worse as infections spread. Novel antibiotics like cefiderocol are desperately needed for some cases which do not respond to the current drugs of last resort. Unfortunately testing for cefiderocol resistance in vitro is difficult, so a sequence-based determination is needed. We see this effort as similar to the use of sequencing to guide selection of the correct antibiotics for tuberculosis cases, a process that Wadsworth has pioneered in the U.S."NGD's recently announced (1) a collaboration with Shionogi, to both enable WGS-based determination of cefiderocol resistance from bacterial whole genome sequence and to use NGD's methods to dissect these ML models to identify mechanisms of resistance and their interplay. The NGD Cefiderocol Consortium that Wadsworth is joining, which has members from both within the US and internationally, reflects the global concern about bacterial infections that the current antibiotics of last resort, the carbapenems, are unable to treat. All Consortium members will participate in publications as they emerge."NGD is assembling a global consortium in connection with our recently announced project with Shionogi," noted Dr. Paul A. Rhodes, NGD Founder and CEO. "Cefiderocol is the first drug of truly novel mechanism of action made available to humanity in 30 years, and we are finding enthusiasm in every quarter for this project. Wadsworth has a long tradition of using WGS to better understand highly antibiotic-resistant infection, and we very much welcome their involvement."NGD has built automated bioinformatic systems both for WGS-based detection of transmission and developed and validated (2) WGS-based machine learning models to determine antibiotic susceptibility in Gram-negative bacteria. These models are proving to be more accurate than in vitro tests in clinically important cases and, moreover, can be dissected to identify complex resistance mechanisms and their interplay. While not yet used for clinical diagnostics, this work is building the foundation that will enable the utilization of the unparalleled depth of information in whole genome sequence which the ever-decreasing cost of sequencing is now making practical for future clinical applications."The Wadsworth Center is well-equipped to participate in this compelling project," noted Dr. Musser, who will lead the project for Wadsworth. "We have deep experience in sequencing and its applications to infectious disease, and as an international crossroads New York is burdened with multidrug, carbapenem-resistant and other hard to treat 'superbugs,' so we are eager to participate in an effort that might enable WGS to be used to determine those cases where cefiderocol may be needed and uniquely effective."About Next Gen DiagnosticsNGD, founded by Dr. Paul A. Rhodes in 2017 along with Sanger Institute group leaders in Cambridge, UK, has built and validated world-leading automation of pathogen bioinformatics, while the unique NGD100 microfluidic sample preparation instrument enables NGD to offer the lowest cost integrated sequencing and bioinformatics services available. NGD combines these capabilities to enable the WGS-based detection of transmission in health care settings and is working with collaborators in the US, Europe and Israel to be among the first to bring WGS-based determination of antibiotic resistance to patient care. NGD is based in the US, with subsidiaries in Cambridge, UK and in Israel.About the Wadsworth Center of the New York State Department of HealthWadsworth Center is the research-intensive public health laboratory of the New York State Department of Health. The Wadsworth Center was established in 1901 and is one of the oldest public health research laboratories in the world. The Center is committed to protecting and improving the health of New Yorkers through laboratory analysis, investigations and research, as well as laboratory certification and educational programs. Scientists study public health issues such as drug resistance to emerging infections, environmental exposures, and basic biological processes that contribute to human health and disease.For press inquiries related to NGD, please contact: [email protected]For press inquiries related to Wadsworth, please contact: [email protected].Contact InformationNext Gen Diagnostics [email protected]SOURCE: Next Gen Diagnostics View the original press release on newswire.com.Source: Next Gen Diagnostics

SCORPIO-PEP is the First Phase 3 Trial with Post-Exposure Prophylactic Use of an Oral Antiviral to Meet the Primary Endpoint of Preventing Symptomatic COVID-19 Infection OSAKA, Japan, October 29, 2024 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) today announced that its double-blind, randomized, placebo-controlled global Phase 3 study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post Exposure Prophylaxis (SCORPIO-PEP), met its primary endpoint. Once-daily ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”) demonstrated a statistically significant reduction in the proportion of participants with symptomatic SARS-CoV-2 infection after exposure to household contacts with COVID-19 when compared to placebo. Specifically, the primary endpoint assessed COVID-19 symptoms onset through Day 10. Ensitrelvir was well tolerated by study participants and no new safety concerns were identified. Ensitrelvir is an investigational oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease. Ensitrelvir was granted Fast Track designation by the U.S. Food and Drug Administration in 2023 for the treatment of COVID-19. In Japan, ensitrelvir, known as Xocova®, received emergency regulatory approval in 2022 and full approval in March 2024 for the treatment of COVID-19. Ensitrelvir was also made available in Singapore based on the Special Access Route application in 2023. It remains an investigational drug outside of Japan and Singapore. “COVID-19 remains an important public health priority, yet there are currently no oral antiviral medications approved for post-exposure prophylactic use. There is a need for convenient, preventive approaches to protect ourselves and those close to us from contracting SARS-CoV-2,” said Simon Portsmouth, MD, FRCP, Senior Vice President, Head of Clinical Development. “These data demonstrate a new potential for post exposure prophylactic use of ensitrelvir, expanding on the breadth of clinical and real-world evidence that establish its activity in those infected with SARS-CoV-2.” SCORPIO-PEP included approximately 2,400 participants aged 12 years and older across the U.S. as well as several countries in South America, Africa and Asia. Study participants with a negative screening test for SARS-CoV-2 infection and no symptoms, who were exposed to a person living in their household with symptomatic COVID-19, were randomly assigned in a 1:1 ratio to receive ensitrelvir (125 mg) or placebo once daily. Study participants began treatment within three days of when the household member with COVID-19 began showing symptoms. Participants then continued ensitrelvir or placebo for five days. Additional details on the study are available on clinicaltrials.gov (NCT05897541). Detailed results from SCORPIO-PEP will be submitted for a presentation at a future scientific conference. Ensitrelvir is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called 3CL protease, which is essential for the replication of the virus. Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting the 3CL protease. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to ensitrelvir for COVID-19. FDA Fast Track designation is designed to facilitate the development and expedite the review of potential new therapies that treat serious conditions and fulfill an unmet medical need. Known as Xocova® in Japan, ensitrelvir received emergency regulatory approval in 2022 and full approval in March 2024. Ensitrelvir was made available in Singapore in November 2023 based on the Special Access Route application. Ensitrelvir remains an investigational drug outside of Japan and Singapore. In addition, the brand name Xocova® has not been approved for use outside of Japan and Singapore and pertains only to the approved drug in Japan and Singapore. Shionogi has a robust clinical development program for ensitrelvir and is committed to making it available to populations worldwide. In addition to SCORPIO-HR, Shionogi evaluated the safety and efficacy of ensitrelvir through SCORPIO-SR, a Phase 2/3 study conducted in Asia, during the Omicron-dominant phase of the epidemic. The data from this study were published in JAMA Network Open. Additionally, an investigator-initiated research study is ongoing in hospitalized patients for the management of COVID-19 as part of the new Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) platform protocol. STRIVE was developed under the auspices of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. Shionogi is also studying the safety and efficacy of ensitrelvir in Japan for children between the ages of 6 to 11 years old. Since 1953, Shionogi has been a leader in infectious disease discovery and commercialization. Our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Today, our global pipeline includes investigational agents developed to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus. As part of our commitment to addressing unmet medical needs, Shionogi is partnering with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi has a landmark license and technology transfer agreement for cefiderocol with Global Antibiotic Research and Development Partnership (GARDP) and a collaboration agreement with the Clinton Health Access Initiative (CHAI) to transform the landscape of access to antibiotics in many low-income countries, most lower middle- and upper middle-income countries, and select high-income countries. View CookiesNamecookie name Namecookie name