Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AT-527 (R07496998), AT-527, AT-527 fasted, AT-527 fed, Period 1: AT-527, AT-527 Formulation 1, AT-527 Formulation 2
AT-527+ rosuvastatin · 13 trials · 10 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
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax)
Area under the concentration-time curve (AUC)
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax)
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)
Maximum plasma concentration (Cmax)
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 | EXPERIMENTAL | - |
| AT-527 BID | EXPERIMENTAL | - |
| AT-527 single dose fasted/fed | EXPERIMENTAL | - |
| AT-527 + rosuvastatin (simultaneous) n=14 | EXPERIMENTAL | - |
| AT-527 + rosuvastatin (staggered) n=14 | EXPERIMENTAL | - |
| AT-527 + digoxin (simultaneous) | EXPERIMENTAL | n=14 |
| AT-527 + digoxin (staggered) | EXPERIMENTAL | n=14 |
| 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-527 550 mg + carbamezepine | EXPERIMENTAL | - |
| AT-527 1100 mg + carbamezepine | EXPERIMENTAL | - |
| AT-527 Formulation 1 Dose 1 | EXPERIMENTAL | - |
| AT-527 Formulation 2 Dose 1 | EXPERIMENTAL | - |
| AT-527 Formulation 2 Dose 2 | EXPERIMENTAL | - |
| AT-527 Formulation 1 Dose 3 | EXPERIMENTAL | - |
| AT-527 Formulation 2 Dose 3 | EXPERIMENTAL | - |
| AT-527 Formulation 2 Dose 1 Fast/Fed | EXPERIMENTAL | - |
| AT-527 Formulation 2 Dose 3 Fast/Fed | 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 fasted | DRUG | AT-527 administered twice daily (BID) for 5 days fasted |
| Placebo Comparator fasted | OTHER | Matching placebo administered twice daily (BID) for 5 days fasted |
| AT-527 fed | DRUG | AT-527 administered twice daily (BID) for 5 days fed |
| Placebo Comparator fed | OTHER | Matching placebo administered twice daily (BID) for 5 days fed |
| AT-527 single dose | DRUG | AT-527 single dose fasted/fed cross-over |
| Drug: AT-527 + rosuvastatin | DRUG | * Day 1: A single dose of rosuvastatin will be administered. * Day 8: A single dose of AT-527 and rosuvastatin will be co-administered. |
| AT-527 + rosuvastatin | DRUG | * Day 1: A single dose of rosuvastatin will be administered. * Day 8: A single staggered dose of AT-527 and rosuvastatin will be administered (2 hours later) |
| AT-527 + digoxin | DRUG | * Day 1: A single dose of digoxin will be administered. * Day 15: A single dose of AT-527 and digoxin will be co-administered. |
| 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 |
| Period 1: AT-527 550 mg | DRUG | AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1 |
| Period 2: carbamazepine | DRUG | Carbamazepine 100 mg twice daily (BID) Days 3 to 6, 200 mg BID on Days 9 to 11, 300 mg BID on Days 12 to 25 |
| Period 3: AT-527 550 mg + carbamazepine | DRUG | AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26 |
| Period 3: AT-527 1100 mg + carbamazepine | DRUG | AT-527 1100 mg tablet (2 x 550 mg tablets, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26 |
| AT-527 Formulation 1 | DRUG | AT-527 Formulation 1 (R07496998) |
| Placebo Comparator | OTHER | Placebo Comparator |
| AT-527 Formulation 2 | DRUG | AT-527 Formulation 2 (R07496998) |
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...
AT-527 is an investigational small molecule being studied for the treatment of Hepatitis C, Chronic Hepatitis C, and COVID-19. It has been evaluated in clinical trials involving healthy volunteers and patients with Hepatitis C virus infection.
AT-527 is being developed by Atea Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AVIR.
AT-527 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not been approved by regulatory authorities. All four clinical trials listed for AT-527 are completed.
AT-527 has been studied in four completed clinical trials: NCT03219957 (Phase 1, healthy and HCV-infected subjects), NCT04019717 (Phase 2, in combination with daclatasvir for HCV), NCT05004415 (Phase 1, mass balance study in healthy males), and NCT05137626 (Phase 1, drug-drug interaction study with digoxin).
Yes, AT-527 is listed as being studied for COVID-19. However, the clinical trial data provided does not specify a dedicated COVID-19 trial, as the completed trials focus on Hepatitis C and healthy volunteer studies.