Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AT-527 · 8 trials · 9 indications
SARS-CoV-2 virus RNA was measured by reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal (NP) swabs. The change from baseline was estimated from an ANCOVA model with baseline viral load as a covariate. Reported here is the adjusted mean change from baseline. A negative change from baseline indicates an improvement.
SARS-CoV-2 virus RNA was measured by reverse-transcription polymerase chain reaction (RT-PCR) from NP swabs. The change from baseline was estimated from an ANCOVA model with baseline viral load as a covariate. Reported here is the adjusted mean change from baseline. A negative change from baseline indicates an improvement.
SVR defined as the HCV RNA \< lower limit of quantitation (LLOQ) at 12 weeks after end of treatment
Total radioactivity recovery in urine and feces
Maximum plasma concentration (Cmax) and Area under the concentration-time curve (AUC)
Maximum plasma concentration (Cmax)
Area under the concentration-time curve (AUC)
Number of subjects experiencing treatment-emergent adverse events
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive AT-527-matched placebo twice a day (BID) on Days 1-5. |
| AT-527 550 mg (1x550 mg) | EXPERIMENTAL | Participants will receive 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5. |
| AT-527 1100 mg (4x275 mg) | EXPERIMENTAL | Participants will receive 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5. |
| 8 weeks | EXPERIMENTAL | - |
| 12 weeks | EXPERIMENTAL | - |
| Group A-Mild Renal Impairment | EXPERIMENTAL | single dose AT-527 |
| Group B-Moderate Renal Impairment | EXPERIMENTAL | single dose AT-527 |
| Group C-Severe Renal Impairment (optional) | EXPERIMENTAL | single dose AT-527 |
| Group D-End-Stage Renal Disease (optional) | EXPERIMENTAL | single dose of AT-527 pre- and post-dialysis |
| Group E-Matched Healthy Subjects | EXPERIMENTAL | Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19 |
| AT-527 550 mg (R07496998) | EXPERIMENTAL | - |
| AT-527 Group A | EXPERIMENTAL | n=8 |
| AT-527 Group B | EXPERIMENTAL | n=8 |
| AT-527 Group C | EXPERIMENTAL | n=8 |
| AT-527 550 mg + midazolam (simultaneous) | EXPERIMENTAL | n=12 |
| AT-527 mg + midazolam (staggered) | EXPERIMENTAL | n=12 |
| AT-527 550 mg + cyclosporine (simultaneous) | EXPERIMENTAL | n=12 |
| AT-527 550 mg + cyclosporine (staggered) | EXPERIMENTAL | n=12 |
| AT-527 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AT-527 | DRUG | Results from Arm AT-527 500 mg determined the dose and regimen to be used for AT-527 1100 mg. |
| Placebo | DRUG | The dose and regimen of the placebo will match that of the respective AT-527 comparator arm. |
| Daclatasvir | DRUG | Inhibitor of HCV nonstructural protein 5A (NS5A) |
| AT-527 and Probenecid | DRUG | Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19 |
| AT-527 (R07496998) | DRUG | Study participants will receive a single radiolabeled dose of 550 mg AT-527. |
| AT-527 550 mg + midazolam | DRUG | Day 1: 2 mg midazolam Day 3: 550 mg AT-527 and 2 mg midazolam in the morning and a second 550 mg AT-527 dose in the evening. Days 4 to 6: 550 mg AT-527 administered twice daily (BID) Day 7: 550 mg AT-527 and 2 mg midazolam in the morning and a second 550 mg AT-527 dose in the evening. Other Names: AT-527 is also know as R07496998 |
| AT-527 550 mg + cyclosporine | DRUG | 550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered simultaneously on Day 7 Other Names: AT-527 is also known as R07496998 |
| Placebo Comparator | OTHER | Matching placebo |
Inclusion Criteria: * Positive SARS-CoV-2 diagnostic test (RT-PCR or rapid antigen test)at screening * Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset ≤5 days prior to randomization Exclusion Criteria: * Clinical signs indicative of COVID-19 i...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Undisclosed |