Nirsevimab

Nirsevimab is a human recombinant monoclonal antibody with activity against respiratory syncytial virus, or RSV for infants.[1][2] It is under development by AstraZeneca and Sanofi.[1][2] Nirsevimab is designed to bind to the fusion protein on the surface of the RSV virus.[3][4]

Nirsevimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetF protein of RSV
Clinical data
Other namesMED-18897, MEDI8897
Routes of
administration		Intramuscular
ATC code
  • None
Identifiers
CAS Number
PubChem SID
DrugBank
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6494H10060N1708O2050S46
Molar mass146336.58 g·mol−1

Medical uses

Nirsevimab is being trialled as an experimental vaccine against respiratory syncytial virus, RSV, in the general infant population. The vaccine intends to replace existing RSV treatment palivizumab, and a single dose is enough for an infants first entire RSV season, Sanofi and AstraZeneca claim.[1][2]

Mechanism of action

Nirsevimab binds to the prefusion conformation of the RSV fusion protein, i.e. it binds to the site at which the virus would attach to a cell; effectively rendering it useless. It has a modified Fc region, extending the half-life of the drug in order for it to last the whole RSV season.[3]

Clinical efficacy

The pivotal MELODY study is an ongoing, randomized, double-blind, placebo-controlled to evaluate the safety and efficacy of nirsevimab in late preterm and term infants. Initial results have been promising, with nirsevimab reducing LRTI (lower respiratory tract infections) by 74.5% compared to placebo in infants born at term or late preterm.[5]

Adverse effects

No major hypersensitivity reactions have been reported, and adverse events of grade 3 or higher were only reported in 8% (77 of 968) of participants in clinical trial NCT02878330.[6][3]

AstraZeneca plans to file for FDA approval within the first half of 2022. If approved, it would be the first RSV vaccine to be approved since palivizumab in 1998.[7]

Research

Ongoing trials for nirsevimab are:

References
  1. "Nirsevimab demonstrated protection against respiratory syncytial virus disease in healthy infants in Phase 3 trial" (Press release). Online: Sanofi. 26 April 2021. Retrieved 27 December 2021.
  2. "Nirsevimab MELODY Phase III trial met primary endpoint of reducing RSV lower respiratory tract infections in healthy infants" (Press release). Online: AstraZeneca. 26 April 2021. Retrieved 27 December 2021.
  3. Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, et al. (Nirsevimab Study Group) (July 2020). "Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants". The New England Journal of Medicine. 383 (5): 415–425. doi:10.1056/NEJMoa1913556. PMID 32726528. S2CID 220876651.
  4. Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, et al. (March 2022). "Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants". The New England Journal of Medicine. 386 (9): 837–846. doi:10.1056/NEJMoa2110275. PMID 35235726. S2CID 247220023.
  5. Zacks Equity Research (March 25, 2022). "Pfizer's (PFE) RSV Jab Gets Another Breakthrough Therapy Tag". Nasdaq. Retrieved April 8, 2022.
  6. Clinical trial number NCT02878330 at ClinicalTrials.gov
  7. Taylor N (June 28, 2021). "AstraZeneca, Sanofi post RSV data ahead of 2022 approval filings". fiercebiotech.com. Retrieved April 8, 2022.
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