Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MEDI-524 (Numax-TM), Motavizumab, motavizumab (MEDI-524)
Medi-524 · 7 trials · 6 indications
RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).
Number of participants reporting one or more AEs
Number of participants reporting one or more AEs considered related to study drug by the investigator
Number of participants reporting one or more SAEs
Number of participants reporting one or more SAEs considered related to study drug by the investigator
Adverse events events were graded by severity; Level 1, 2, 3, or 4
Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs
Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.
Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.
Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose.
Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing
Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30. Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA).
| Arm | Type | Description |
|---|---|---|
| palivizumab | ACTIVE_COMPARATOR | 15 mg/kg administered intramuscularly for 5 monthly doses |
| motavizumab (MEDI-524) | EXPERIMENTAL | 15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses |
| Motavizumab followed by Palivizumab | EXPERIMENTAL | 2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) |
| Palivizumab followed by motavizumab | EXPERIMENTAL | 2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) |
| Motavizumab control | EXPERIMENTAL | 5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) |
| Motavizumab | EXPERIMENTAL | Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a maximum of 5 scheduled doses. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. |
| Pailvizumab | ACTIVE_COMPARATOR | Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a maximum of 5 scheduled doses. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. |
| motavizumab (MEDI-524) 15 mg/kg | EXPERIMENTAL | A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled. |
| palivizumab 15 mg/kg | ACTIVE_COMPARATOR | A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled. |
| Motavizumab, 3 mg/kg as a single intravenous dose | EXPERIMENTAL | Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0 |
| Motavizumab, 15 mg/kg as a single intravenous dose | EXPERIMENTAL | Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0 |
| Motavizumab, 30 mg/kg as a single intravenous dose | EXPERIMENTAL | Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0 |
| Placebo, as a single intravenous dose | PLACEBO_COMPARATOR | Placebo, as a single intravenous dose administered on Day 0 |
| 1 | ACTIVE_COMPARATOR | MEDI-524 |
| 2 | EXPERIMENTAL | MEDI-524 (Numax-TM) |
| 3 | EXPERIMENTAL | MEDI-524 (Numax-TM) |
| 4 | EXPERIMENTAL | MEDI-524 (Numax-TM) |
| 5 | EXPERIMENTAL | MEDI-524 (Numax-TM) |
| Name | Type | Description |
|---|---|---|
| motavizumab (MEDI-524) | BIOLOGICAL | Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses |
| palivizumab | BIOLOGICAL | Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses |
| Motavizumab, palivizumab | BIOLOGICAL | Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl. |
| Palivizumab, motavizumab | BIOLOGICAL | Palivizumab was provided in sterile vials containing 100 mg of palivizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine, and 1.6 mM glycine. |
| Motavizumab | BIOLOGICAL | Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl. |
| palivizumab 15 mg/kg | BIOLOGICAL | Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections. |
| Placebo | OTHER | Single dose of placebo administered intravenously (in the vein) on Day 0 |
| Medi-524 | BIOLOGICAL | IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals |
| MEDI-524 (Numax-TM) | BIOLOGICAL | Grp.1: 3 mg/kg IV (single dose) |
Inclusion Criteria: * 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) wit...
Medi-524 is an investigational monoclonal antibody developed by AstraZeneca PLC for respiratory syncytial virus infections. It has been studied in Phase 1 clinical trials, including a dose-escalation study in children and a safety and pharmacokinetics trial in healthy adults. It is not approved and remains in clinical development.
Medi-524 is being developed for the prevention or treatment of respiratory syncytial virus infections. Its clinical program focused on children aged 6 months and older in Argentina and Chile, and on healthy adults in the United States. The trials evaluated safety, tolerability, pharmacokinetics, and dose escalation rather than confirmed efficacy.
Medi-524 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the Phase 1 clinical program for the monoclonal antibody in respiratory syncytial virus infections.
Medi-524 is in Phase 1 development. Both of its registered trials were Phase 1 studies and both are now completed, with no active trials ongoing. The program enrolled 247 participants in total across the two studies.
Medi-524 has been studied in two completed Phase 1 trials. NCT00192478 was an open-label dose-escalation study of 2 to 5 intramuscular doses at 3 mg/kg or 15 mg/kg in children, enrolling 217 participants in Argentina and Chile. NCT00192465 evaluated safety, tolerability, and pharmacokinetics in 30 healthy adults in the United States.
Yes. Medi-524 is also known as MEDI-524 (Numax-TM). Both names refer to the same investigational monoclonal antibody developed by AstraZeneca for respiratory syncytial virus infections, so searches for either name point to the same Phase 1 asset.