Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bemnifosbuvir · 5 trials · 10 indications
SVR12 defined as plasma hepatitis C virus (HCV) RNA less than the lower limit of quantitation (\<LLOQ) at 12 weeks post-treatment
C-QTc analysis
| Arm | Type | Description |
|---|---|---|
| Bemnifosbuvir (BEM) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Bemnifosbuvir and Ruzasvir | EXPERIMENTAL | Bemnifosbuvir (BEM; AT-527) Tablets Ruzasvir (RZR; AT-038) Capsules |
| Bemnifosbuvir (BEM) therapeutic dose | EXPERIMENTAL | oral tablets |
| Bemnifosbuvir (BEM) supratherapeutic dose | EXPERIMENTAL | oral tablets |
| Moxifloxacin | ACTIVE_COMPARATOR | oral tablet |
| Group 1 -Mild Hepatic Impairment | EXPERIMENTAL | Drug: single dose Bemnifosbuvir (BEM) |
| Group 2-Moderate Hepatic Impairment | EXPERIMENTAL | Drug: single dose Bemnifosbuvir (BEM) |
| Group 3 - Healthy Subjects matching mild and moderate impairment groups | EXPERIMENTAL | Drug: single dose Bemnifosbuvir (BEM) |
| Group 4 - Severe Hepatic Impairment | EXPERIMENTAL | Drug: single dose Bemnifosbuvir (BEM) |
| Group 5 - Normal hepatic function matching severe impairment group | EXPERIMENTAL | Drug: single dose Bemnifosbuvir (BEM) |
| 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 |
| Moxifloxacin | DRUG | A single dose of Moxifloxacin will be administered. |
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 small molecule being studied for the treatment of chronic Hepatitis C virus infection and for SARS-CoV-2 infection (COVID-19). It has been evaluated in clinical trials for these infectious disease indications, though it is not yet approved and remains in clinical development.
Bemnifosbuvir is a small molecule antiviral that targets viral RNA polymerase, an enzyme essential for viral replication. By inhibiting this polymerase, the drug aims to block the replication of viruses such as SARS-CoV-2 and Hepatitis C virus, thereby reducing viral load in infected patients.
Bemnifosbuvir is being developed by Atea Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AVIR. The company is conducting clinical trials to evaluate the drug's safety and efficacy for treating viral infections, including COVID-19 and chronic Hepatitis C.
Bemnifosbuvir has completed Phase 1, Phase 2, and Phase 3 clinical trials. A Phase 3 trial for COVID-19 and a Phase 2 trial for chronic Hepatitis C have both been completed. The drug has received Fast Track designation from the FDA, but it is not yet approved and remains investigational.
Bemnifosbuvir has been studied in several completed trials, including NCT05629962 (SUNRISE-3, a Phase 3 trial in high-risk outpatients with COVID-19), NCT05904470 (a Phase 2 trial in chronic Hepatitis C), and two Phase 1 trials in healthy volunteers (NCT05905484 and NCT05905497).
No, Bemnifosbuvir is not the same as Ruzasvir. They are separate investigational drugs that have been studied in combination for the treatment of chronic Hepatitis C. In a Phase 2 clinical trial, Bemnifosbuvir was administered together with Ruzasvir to evaluate their combined safety and efficacy in patients with chronic HCV.