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Also known as Bemnifosbuvir (BEM), AT-527, AT-527 fed, AT-527 single dose
Bemnifosbuvir · 2 trials · 7 indications
SVR12 defined as plasma hepatitis C virus (HCV) RNA less than the lower limit of quantitation (\<LLOQ) at 12 weeks post-treatment
| Arm | Type | Description |
|---|---|---|
| Bemnifosbuvir (BEM) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Bemnifosbuvir and Ruzasvir | EXPERIMENTAL | Bemnifosbuvir (BEM; AT-527) Tablets Ruzasvir (RZR; AT-038) Capsules |
| Name | Type | Description |
|---|---|---|
| Bemnifosbuvir (BEM) | DRUG | BEM tablets administered orally every 12 hours (twice a day) for a total of 5 days |
| Placebo | DRUG | Placebo tablets administered orally every 12 hours (twice a day) for a total of 5 days |
| Bemnifosbuvir | DRUG | 550 mg administered orally once a day (QD) for 8 weeks |
| Ruzasvir | DRUG | 180 mg administered orally once a day (QD) for 8 weeks |
Inclusion Criteria: * Positive SARS-CoV-2 test conducted ≤ 5 days prior to randomization * Mild or moderate COVID-19 with symptom onset ≤ 5 days before randomization and at least one COVID-19 related symptom present at time of screening * Subject must be high risk, defined below: 1. Age ≥70 year...
Bemnifosbuvir is an investigational antiviral being studied for chronic hepatitis C virus infection and for SARS-CoV-2 infection (COVID-19). In hepatitis C it is being developed as part of a fixed-dose combination with ruzasvir. In COVID-19 it was studied as a single agent in high-risk outpatients. It is not approved for any use.
Bemnifosbuvir is being developed by Atea Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker AVIR. Atea is the sponsor of the clinical program evaluating bemnifosbuvir both as a single agent in COVID-19 and in combination with ruzasvir for chronic hepatitis C.
Bemnifosbuvir is in Phase 2 development for chronic hepatitis C virus, where it is being evaluated with ruzasvir as a fixed-dose combination. It has also been studied in a completed Phase 3 trial in high-risk outpatients with COVID-19. Bemnifosbuvir is investigational and has not been approved by the FDA.
Two trials are registered for bemnifosbuvir. NCT05904470 is a completed Phase 2 study of bemnifosbuvir and ruzasvir in 275 subjects with chronic HCV, run across the United States, Brazil, Canada, India, and other countries. NCT05629962, called SUNRISE-3, is a completed Phase 3 study of bemnifosbuvir in 2,285 high-risk COVID-19 outpatients.
In chronic hepatitis C, bemnifosbuvir is being developed as part of a fixed-dose combination with ruzasvir, abbreviated BEM/RZR. The completed Phase 2 trial NCT05904470 evaluated this combination in 275 adults with chronic HCV, including patients with hepatic cirrhosis, across multiple countries. The combination remains investigational.