Summary of COVID-19 bemnifosbuvir studies
1. Horga et al., Oral bemnifosbuvir (AT-527) vs placebo in patients with mild-to-moderate COVID-19 in an outpatient setting (MORNINGSKY)
207 patient bemnifosbuvir early treatment RCT: 71% lower hospitalization (p=0.05), 28% lower progression (p=0.49), 28% slower recovery, and 22% improved viral clearance (p=0.21).MORNINGSKY RCT which was terminated early after enrolling only 216 of 1,386 planned participants. The trial did not meet its primary endpoint, with the bemnifosbuvir group having longer time to symptom improvement than placebo. However, compared to placebo, bemnifosbuvir was associated with a 71% relative risk reduction in COVID-19 hospitalizations and fewer COVID-19 complications and medically attended visits, despite no significant improvement in viral load.
Oct 2023, Future Virology, https://www.futuremedicine.com/doi/10.2217/fvl-2023-0115, https://c19p.org/horga
2. Horga et al., Phase II study of bemnifosbuvir in high-risk participants in a hospital setting with moderate COVID-19
83 patient bemnifosbuvir late treatment RCT: 86% lower mortality (p=0.24), 2% improved recovery (p=1), and 9% improved viral clearance (p=0.8).Phase 2 RCT investigating bemnifosbuvir for the treatment of 81 high-risk COVID-19 patients hospitalized with moderate disease. The trial was terminated early due to difficulties with enrollment. There was no significant difference between bemnifosbuvir and placebo for the primary outcome of disease progression or most secondary outcomes. However, viral load declined faster in the bemnifosbuvir group between days 2 and 8. All 3 deaths occurred in the placebo group. The safety profile was similar between groups. While results are very limited by small sample size and early termination, they suggest bemnifosbuvir may accelerate viral clearance and could play a role in preventing progression.
Jun 2023, Future Virology, https://www.futuremedicine.com/doi/10.2217/fvl-2023-0064, https://c19p.org/horga2
69 patient bemnifosbuvir early treatment RCT: 3% improved viral clearance (p=0.14).
RCT 100 mild/moderate COVID-19 patients showing no significant difference in nasopharyngeal viral load reduction between bemnifosbuvir (550mg or 1100mg twice daily for 5 days) and placebo groups.
Aug 2023, Microbiology Spectrum, https://journals.asm.org/doi/10.1128/spectrum.00077-23, https://c19p.org/boffito
4. Hammond et al., A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19
2,285 patient bemnifosbuvir early treatment RCT: 202% higher mortality (p=0.37), 253% higher hospitalization (p=0.11), and 24% improvement (p=0.66).RCT 2,285 high-risk outpatients showing no significant difference in outcomes with bemnifosbuvir treatment.
May 2024, NCT05629962, https://clinicaltrials.gov/study/NCT05629962, https://c19p.org/hammond5