539. Efficacy in Multiple SARS-CoV-2 Animal Models Supports Phase 3 Dose Selection for Obeldesivir Article Swipe
Jared Pitts
,
Darius Babusis
,
Rita Humeniuk
,
David R. Martinez
,
Robert M. Cox
,
Alexandra Schäfer
,
Nicholas C. Riola
,
Joy Y. Feng
,
Venice Du Pont
,
Olena Anoshchenko
,
Meghan S. Vermillion
,
Mazin Abdelghany
,
Robert H. Hyland
,
Sandhya Girish
,
Timothy P. Sheahan
,
Richard K. Plemper
,
Ralph S. Baric
,
Tomáš Cihlář
,
Joe Llewellyn
,
Helen Winter
,
Roy Bannister
,
Raju Subramanian
,
Richard L. Mackman
,
John P. Bilello
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1093/ofid/ofad500.608
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1093/ofid/ofad500.608
Background Remdesivir (RDV, Veklury) is the first FDA-approved direct-acting antiviral treatment for COVID-19. While RDV requires IV administration, obeldesivir (ODV, GS-5245) is an oral prodrug of GS-441524, the parent nucleoside of RDV, designed for effective oral delivery. ODV is being tested in two Phase 3 clinical studies for outpatient treatment of COVID-19. Methods In vitro ODV activity against SARS-CoV-2 was assessed in A549-hACE2 cells. In vivo therapeutic efficacy of oral ODV was evaluated in mouse, ferret, and African Green Monkey (AGM) SARS-CoV-2 models. GS-441524 pharmacokinetics (PK) following ODV oral administration was assessed in animals and in a Phase 1 study in humans. Results ODV is a potent inhibitor of SARS-CoV-2 in vitro (EC50 = 1.9 µM) and showed 2- to 7-fold increased GS-441524 oral bioavailability in multiple animal models compared to parent GS-441524. Oral ODV reduced infectious lung viral loads by 2.8 log10 plaque forming units (pfu)/g tissue and ameliorated viral pathophysiological effects in a pathogenic mouse model of SARS-CoV-2 when dosed at 10 mg/kg twice daily beginning 12 hours post infection (hpi). In a SARS-CoV-2 asymptomatic upper airway infection ferret model, oral ODV dosed once daily at 20 mg/kg starting 12 hpi reduced nasal infectious viral titers by >3.3 log10 pfu/mL. Viral transmission among co-housed ferrets was also prevented by ODV. Once daily oral administration of 60 mg/kg ODV in SARS-CoV-2 infected AGMs initiated 8 hpi significantly reduced viral loads in bronchoalveolar lavage and multiple respiratory tissues. Efficacious oral doses of ODV in the mouse, ferret and AGM models were achieved at estimated plasma GS-441524 exposures (AUC0-24h) of 36, 98 and 111 µM·h, respectively. Based on PK data from a Phase 1 dose escalation study in healthy volunteers, an ODV dose of 350 mg twice daily (BID) is expected to achieve plasma GS-441524 exposures (77-103 µM·h) in the efficacious range derived from these animal models. Conclusion ODV is a promising investigational oral COVID-19 treatment based on its preclinical in vitro and in vivo SARS-CoV-2 efficacy, its oral bioavailability in preclinical species, and its oral PK and safety profile in a Phase 1 trial. Collectively, these data support the 350 mg BID dose for the ongoing Phase 3 clinical trials. Disclosures Jared Pitts, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Darius Babusis, BA, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Rita Humeniuk, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Nicholas C. Riola, BS, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Joy Feng, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Venice Du Pont, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Olena Anoshchenko, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Meghan Vermillion, DVM, PhD, Gilead Sciences, Inc.: Employee Mazin Abdelghany, MD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Robert H. Hyland, DPhil, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Sandhya Girish, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Tomas Cihlar, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Joe Llewellyn, PharmD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Helen Winter, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Roy Bannister, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Raju Subramanian, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds Richard L. Mackman, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds John P. Bilello, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds
Related Topics
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1093/ofid/ofad500.608
- https://academic.oup.com/ofid/article-pdf/10/Supplement_2/ofad500.608/53777367/ofad500.608.pdf
- OA Status
- gold
- Cited By
- 3
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4389031853
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W4389031853Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1093/ofid/ofad500.608Digital Object Identifier
- Title
-
539. Efficacy in Multiple SARS-CoV-2 Animal Models Supports Phase 3 Dose Selection for ObeldesivirWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-11-27Full publication date if available
- Authors
-
Jared Pitts, Darius Babusis, Rita Humeniuk, David R. Martinez, Robert M. Cox, Alexandra Schäfer, Nicholas C. Riola, Joy Y. Feng, Venice Du Pont, Olena Anoshchenko, Meghan S. Vermillion, Mazin Abdelghany, Robert H. Hyland, Sandhya Girish, Timothy P. Sheahan, Richard K. Plemper, Ralph S. Baric, Tomáš Cihlář, Joe Llewellyn, Helen Winter, Roy Bannister, Raju Subramanian, Richard L. Mackman, John P. BilelloList of authors in order
- Landing page
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https://doi.org/10.1093/ofid/ofad500.608Publisher landing page
- PDF URL
-
https://academic.oup.com/ofid/article-pdf/10/Supplement_2/ofad500.608/53777367/ofad500.608.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
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https://academic.oup.com/ofid/article-pdf/10/Supplement_2/ofad500.608/53777367/ofad500.608.pdfDirect OA link when available
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Pharmacokinetics, Medicine, Oral administration, Bioavailability, In vivo, Pharmacology, Titer, Prodrug, Virology, Virus, Biology, BiotechnologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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3Total citation count in OpenAlex
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2025: 1, 2024: 2Per-year citation counts (last 5 years)
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10Other works algorithmically related by OpenAlex
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| primary_location.source.host_organization_lineage_names | Oxford University Press, University of Oxford |
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| primary_location.pdf_url | https://academic.oup.com/ofid/article-pdf/10/Supplement_2/ofad500.608/53777367/ofad500.608.pdf |
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| publication_date | 2023-11-27 |
| publication_year | 2023 |
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