Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Presatovir · 4 trials · 3 indications
The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factors.
The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
A Lower Respiratory Tract Complication (LRTC) was defined as one of the below as determined by the adjudication committee: * Primary RSV lower respiratory tract infection (LRTI) * Secondary bacterial LRTI * LRTI due to unusual pathogens * Lower respiratory tract complication of unknown etiology
The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
| Arm | Type | Description |
|---|---|---|
| Presatovir | EXPERIMENTAL | Presatovir 200 mg (4 x 50 mg) on Day 1, followed by 100 mg (2 x 50 mg) from Day 2 to Day 14 |
| Placebo | PLACEBO_COMPARATOR | Placebo tablets for a total of 14 days |
| Presatovir placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of presatovir placebo. |
| Name | Type | Description |
|---|---|---|
| Presatovir | DRUG | Tablets administered orally or via nasogastric (NG) tube once daily |
| Placebo | DRUG | Tablets administered orally or via NG tube once daily |
| Presatovir placebo | DRUG | Presatovir placebo tablets administered orally |
Key Inclusion Criteria: * Males and females ≥18 years of age who have received a LT (single or double) or heart/lung transplant \> 90 days prior to Screening * Confirmed to be RSV-positive by local polymerase chain reaction (PCR) testing (starting from when the upper or lower respiratory tract samp...
Presatovir is an investigational small molecule being developed for the treatment of Respiratory Syncytial Virus (RSV) infection. It has been studied in hospitalized adults and in hematopoietic cell transplant and lung transplant recipients with RSV infection of the upper or lower respiratory tract.
Presatovir is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. The company has sponsored Phase 2 clinical trials evaluating the drug in patients with Respiratory Syncytial Virus infection.
Presatovir is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Multiple Phase 2 trials have been completed, but the drug remains in clinical development and is not yet available as a licensed therapy.
Presatovir has been studied in four completed Phase 2 trials: NCT02135614 in hospitalized adults with RSV, NCT02254408 in hematopoietic cell transplant recipients with upper respiratory tract RSV, NCT02254421 in hematopoietic cell transplant recipients with lower respiratory tract RSV, and NCT02534350 in lung transplant recipients with RSV.
Presatovir is a small molecule antiviral that targets the Respiratory Syncytial Virus fusion protein, inhibiting viral entry into host cells. By blocking this fusion process, the drug aims to prevent the virus from replicating and spreading within the respiratory tract.
Presatovir is also known by the developmental code GS-5806. It is an investigational antiviral drug being studied for the treatment of Respiratory Syncytial Virus infection, and both names refer to the same compound developed by Gilead Sciences.