Phase II study of bemnifosbuvir in high-risk participants in a hospital setting with moderate COVID-19
Arantxa Horga, Daniel R Kuritzkes, John J Kowalczyk, Keith Pietropaolo, Bruce Belanger, Kai Lin, Kristen Perkins, Janet Hammond
Future Virology, doi:10.2217/fvl-2023-0064
Background: Bemnifosbuvir, a novel, oral, nonmutagenic, nonteratogenic nucleotide analogue inhibits SARS-CoV-2 replication in vitro. Materials & methods: Adults in hospital settings with moderate COVID-19 were randomized 1:1 bemnifosbuvir/placebo. Study amended to two parts after interim analysis; part B enrollment limited owing to evolving standard of care. Results: Although the study ended early and did not meet the primary efficacy end point, bemnifosbuvir was well tolerated and did not contribute to allcause mortality. Compared with placebo, bemnifosbuvir treatment resulted in 0.61 log 10 greater viral load mean change on day 2; trend sustained through day 8. Treatment-emergent adverse events were similar in both groups; most were mild/moderate, unrelated to study drug. Conclusion: Our results suggest a potential role for bemnifosbuvir in blunting COVID-19 progression. Clinical Trial Registration: NCT04396106 (ClinicalTrials.gov) Tweetable abstract: #Bemnifosbuvir, a novel/oral/nonmutagenic/nonteratogenic/nucleotide analogue with low DDI/resistance potential, inhibits SARS-CoV-2 replication and was well tolerated, did not contribute to all cause mortality and resulted in greater viral load mean change. Results suggest potential to blunt #COVID-19 progression.
Supplementary data To view the supplementary data that accompany this paper please visit the journal website at: www.futuremedicine.com/doi/ suppl/10.2217/fvl-2023-0064
Author contributions All authors were involved in the development of the study protocols; in the collection, analysis and interpretation of study data; in writing of the clinical study report; and in the decision to submit the article for publication.
Ethical conduct of research The authors state that they have obtained appropriate institutional review board approval and have followed the principles outlined in the Declaration of Helsinki for all human experimental investigations. In addition, informed consent has been obtained from the participants involved.
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