Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Suptavumab/kg · 1 trial · 1 indication
Part A was primarily designed to determine the pharmacokinetics (PK) of suptavumab in infants to inform the dose regimen used in Part B of the study. The study protocol specified the process and criteria for assessment of the dose. The dose used in Part B was to remain the same as Part A if the PK data up to Day 57 demonstrated that the individual PK observations were consistent with model-predicted concentrations, following age and body weight corrections.
A medically attended RSV infection defined as an infant with positive RSV test by Reverse-transcriptase polymerase chain reaction (RT-PCR) with any of following events: Hospitalized (on basis of assessment of admitting physician) for RSV infection or outpatient visit (emergency room \[ER\], urgent care \[UC\], or pediatric clinic visits \[for either a sick or well visit\]) with RSV lower respiratory tract infection (LRTI). An RSV LRTI in an infant: RSV proven respiratory infection (i.e positive RSV RT-PCR test) with parent(s)/guardian(s) report of cough/difficulty breathing, \& with 1 of following signs of LRTI, as assessed by healthcare provider: - lower chest wall in drawing -hypoxemia (peripheral capillary oxygen saturation \<95% breathing room air) - Wheezing/crackles. The 150-day efficacy assessment period: first study drug intake through the Day 150 visit.
| Arm | Type | Description |
|---|---|---|
| Part A: Suptavumab 30 mg/kg | EXPERIMENTAL | - |
| Part B: Placebo Matched to Suptavumab | EXPERIMENTAL | - |
| Part B: Suptavumab 30 mg/kg- 1 Dose | EXPERIMENTAL | - |
| Part B: Suptavumab 30 mg/kg - 2 Doses | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Suptavumab 30 mg/kg | DRUG | Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1. |
| Placebo Matched to Suptavumab | DRUG | Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57. |
| Suptavumab 30 mg/kg- 1 Dose | DRUG | Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57. |
| Suptavumab 30 mg/kg - 2 Doses | DRUG | Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57. |
Key Inclusion Criteria: 1. Preterm, otherwise healthy male or female infant who is ≤6 months of age at the time of the first dose (i.e., infant must be treated on or before their 6 month birthday) 2. Gestational age is ≤35 weeks, 6 days at birth 3. Parent(s) or legal guardian(s) of the infant is ab...
Suptavumab/kg is an investigational monoclonal antibody developed for the prevention of medically attended respiratory syncytial virus (RSV) infection in preterm infants. It was studied in a Phase 3 trial in that population. It is not an approved treatment for RSV.
Suptavumab/kg is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron sponsored the Phase 3 clinical program evaluating the antibody for RSV prevention in preterm infants.
Suptavumab/kg reached Phase 3 clinical development. Its single Phase 3 trial, NCT02325791, has been completed, and no active trials are currently listed. The asset remains investigational and has not been approved for any indication.
Suptavumab/kg was evaluated in one Phase 3 trial, NCT02325791, titled a study of suptavumab (REGN2222) for prevention of medically attended RSV infection in preterm infants. The trial enrolled 1,177 participants across the United States, Australia, Canada, Europe, and other regions, and it is completed.