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

doi:10.2217/fvl-2023-0064

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

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

Authors

Arantxa Horga¹, Daniel R Kuritzkes², John J Kowalczyk³, Keith Pietropaolo¹, Bruce Belanger¹, Kai Lin¹, Kristen Perkins¹, Janet Hammond¹

Affiliations

¹ Atea Pharmaceuticals, Boston, MA 02110, USA.
² Brigham & Women's Hospital, Division of Infectious Disease, Boston, MA 02115, USA.
³ American Institute of Research, Los Angeles, CA 90017, USA.

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.

Associated data

ClinicalTrials.gov/NCT04396106