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. |
| 1 | ACTIVE_COMPARATOR | MEDI-524 |
| 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 |
| 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. |
| Medi-524 | BIOLOGICAL | IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals |
| Placebo | OTHER | Single dose of placebo administered intravenously (in the vein) on Day 0 |
| 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 being developed for the prevention of respiratory syncytial virus (RSV) infections. It is an investigational biologic studied in children and in healthy adults. Its clinical program focused on RSV, a common cause of lower respiratory tract illness, particularly in young children.
Medi-524 is developed by AstraZeneca PLC, which trades under the ticker AZN. The drug is also referred to as MEDI-524 and Numax-TM.
Medi-524 is in Phase 1/2 clinical development. It is an investigational biologic and is not described as FDA approved. Two clinical trials of Medi-524 have been completed, and no trials are currently active.
Medi-524 has been studied in two completed trials. NCT00192478 was an open-label, dose-escalation Phase 1/2 study of 2 to 5 intramuscular doses of MEDI-524 at 3 mg/kg or 15 mg/kg in children in Argentina and Chile, enrolling 217 participants. NCT00192465 was a Phase 1 trial evaluating safety, tolerability, and pharmacokinetics in 30 healthy adults in the United States.
Yes, Medi-524 is also known as MEDI-524 and Numax-TM. These names refer to the same investigational biologic developed by AstraZeneca for respiratory syncytial virus infections.
Across its two completed clinical trials, Medi-524 has enrolled a total of 247 participants. The larger trial, NCT00192478, enrolled 217 children, while NCT00192465 enrolled 30 healthy adults. Both studies were controlled, and the pediatric study was randomized.