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Also known as AT-527 (R07496998), AT-527, AT-527 fed, AT-527 Formulation 1, AT-527 Formulation 2
AT-527+ rosuvastatin · 3 trials · 6 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
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 | - |
| 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) |
| 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...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
AT-527 + rosuvastatin refers to the investigational small molecule AT-527 studied alongside rosuvastatin in drug interaction research. AT-527 is being developed by Atea Pharmaceuticals, Inc. (AVIR) for infectious disease indications including COVID-19 and chronic hepatitis C. The combination appears among the treatment arms used to evaluate how AT-527 affects other medications.
AT-527 is being studied for the treatment of COVID-19 and chronic hepatitis C virus infection. Atea Pharmaceuticals has evaluated it in non-hospitalized adults with mild or moderate COVID-19 and in patients with hepatitis C, including a study combining AT-527 with daclatasvir. These programs remain investigational and are in clinical development.
AT-527 is developed by Atea Pharmaceuticals, Inc., which trades under the ticker AVIR. The company is the sponsor of the clinical studies evaluating AT-527 in COVID-19 and hepatitis C, including the drug interaction studies that pair AT-527 with agents such as rosuvastatin, midazolam, digoxin, carbamazepine, and cyclosporine.
AT-527 has been studied in Phase 2 clinical trials, with earlier Phase 1 work also completed. The Phase 2 program includes a completed study in non-hospitalized adults with mild or moderate COVID-19 and a completed Phase 2 study of AT-527 combined with daclatasvir in patients with hepatitis C virus infection. AT-527 is investigational and has not been approved.
AT-527 has been evaluated in completed trials including NCT04709835, a Phase 2 study of AT-527 in non-hospitalized adults with mild or moderate COVID-19, and NCT04019717, a Phase 2 study of AT-527 with daclatasvir in hepatitis C patients. An earlier Phase 1 study, NCT03219957, enrolled healthy and HCV-infected subjects.