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. 2023 Jun;18(8):489-500.
doi: 10.2217/fvl-2023-0064. Epub 2023 Jun 23.

Phase II study of bemnifosbuvir in high-risk participants in a hospital setting with moderate COVID-19

Arantxa Horga  1 , Daniel R Kuritzkes  2 , John J Kowalczyk  3 , Keith Pietropaolo  1 , Bruce Belanger  1 , Kai Lin  1 , Kristen Perkins  1 , Janet Hammond  1
Affiliations

Phase II study of bemnifosbuvir in high-risk participants in a hospital setting with moderate COVID-19

Arantxa Horga et al. Future Virol. 2023 Jun.

Abstract

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 all-cause mortality. Compared with placebo, bemnifosbuvir treatment resulted in 0.61 log10 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).

Keywords: AT-527; COVID-19; SARS-CoV-2; bemnifosbuvir; oral.

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Conflict of interest statement

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Figures

Figure 1.
Figure 1.. CONSORT diagram.
AE: Adverse event; ITT: Intent-to-treat.
Figure 2.
Figure 2.. Progressive respiratory insufficiency at day 14.
PRI: Progressive respiratory insufficiency.
Figure 3.
Figure 3.. SARS-CoV-2 clearance.
(A) ANCOVA adjusted mean change from baseline in quantitative SARS-CoV-2 virus RNA (adjusted for baseline SARS-CoV-2 RNA), modified intent-to-treat population. Error bars denote standard error (SE). (B) Proportion of participants with negative SARS-CoV-2 PCR test, modified intent-to-treat population. Error bars denote SE. (C) ANCOVA adjusted mean change from baseline in quantitative SARS-CoV-2 virus RNA (adjusted for baseline SARS-CoV-2 RNA) for participants with baseline viral load ≥5.36 log10. Error bars denote SE. (D) Proportion of participants with baseline viral load ≥5.36 log10 with negative SARS-CoV-2 PCR test. Error bars denote SE.
Figure 3.
Figure 3.. SARS-CoV-2 clearance.
(A) ANCOVA adjusted mean change from baseline in quantitative SARS-CoV-2 virus RNA (adjusted for baseline SARS-CoV-2 RNA), modified intent-to-treat population. Error bars denote standard error (SE). (B) Proportion of participants with negative SARS-CoV-2 PCR test, modified intent-to-treat population. Error bars denote SE. (C) ANCOVA adjusted mean change from baseline in quantitative SARS-CoV-2 virus RNA (adjusted for baseline SARS-CoV-2 RNA) for participants with baseline viral load ≥5.36 log10. Error bars denote SE. (D) Proportion of participants with baseline viral load ≥5.36 log10 with negative SARS-CoV-2 PCR test. Error bars denote SE.
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