Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALX-0171 · 5 trials · 4 indications
The primary endpoint for this trial was the time needed for the viral load to drop below the quantification limit (time-to-BQL) of the plaque assay in nasal mid-turbinate swab specimens. Time-to-BQL was defined as the time from the first study drug administration to the first occurrence of a value below the quantification limit (BQL), provided the next measured value was also below the limit of quantification. The time to BQL for subjects with missing data and/or who did not reach BQL during the trial were censored at the last non-missing viral load assessment. The primary endpoint was analysed using logrank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05. The comparisons were performed in the following order: ALX-0171 9 mg/kg vs Placebo, followed by ALX-0171 6mg/kg vs Placebo, ALX-0171 3mg/kg vs Placebo.
| Arm | Type | Description |
|---|---|---|
| ALX-0171 3.0 mg/kg | EXPERIMENTAL | Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days |
| ALX-0171 6.0 mg/kg | EXPERIMENTAL | Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days |
| ALX-0171 Dose 9.0mg/kg | EXPERIMENTAL | Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days |
| Placebo | PLACEBO_COMPARATOR | Inhalation of Placebo once daily for 3 consecutive days |
| ALX-0171 | EXPERIMENTAL | Inhalation of ALX-0171 during 3 consecutive days |
| ALX-0171 Oral inhalation | EXPERIMENTAL | - |
| ALX-0171 Oral Inhalation - Single Dose (SD) | EXPERIMENTAL | - |
| ALX-0171 Oral Inhalation - Multiple Dose (MD) | EXPERIMENTAL | - |
| ALX-0171 Intravenous (IV) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ALX-0171 3.0 mg/kg | BIOLOGICAL | - |
| ALX-0171 6.0 mg/kg | BIOLOGICAL | - |
| ALX-0171 9.0 mg/kg | BIOLOGICAL | - |
| Placebo | OTHER | - |
| ALX-0171 | BIOLOGICAL | - |
Inclusion Criteria: 1. Male or female infant or young child aged 28 days to \< 2 years with gestational age ≥ 33 weeks at screening. 2. Subject weighed between ≥ 3.0 kg and \< 15.0 kg at screening. 3. Subject is otherwise healthy but was hospitalized for and clinically diagnosed with RSV LRTI (bron...
ALX-0171 is an investigational monoclonal antibody developed by Sanofi for the treatment of respiratory syncytial virus (RSV) infection, including RSV lower respiratory tract infection. It is given to infants and young children hospitalized with RSV lower respiratory tract infection and has been studied in adults as well. It remains in clinical development.
ALX-0171 is being developed to treat respiratory syncytial virus infection, particularly RSV lower respiratory tract infection in hospitalized infants. Clinical studies enrolled infants from 28 days of age who were hospitalized and diagnosed with RSV lower respiratory tract infection, as well as adults with hyperresponsive airways and healthy adult volunteers.
ALX-0171 is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the monoclonal antibody in respiratory syncytial virus infection.
ALX-0171 is investigational and remains in clinical development. Its program includes Phase 1 studies and a Phase 2 dose-ranging study in infants hospitalized for RSV lower respiratory tract infection. It is not described as approved by the FDA, and no trials are currently active.
Four completed studies are registered for ALX-0171: NCT02979431, a Phase 2 dose-ranging study in 180 infants hospitalized for RSV lower respiratory tract infection; NCT02309320, a Phase 1 study in 53 infants and toddlers; NCT01909843, a Phase 1 safety study in 24 adults with hyperresponsive airways; and NCT01875926, a Phase 1 pharmacokinetic study in 44 healthy male volunteers.