Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants

Summary

The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age at the time of enrollment in their respective geographic location. In order to optimize the potential benefit in this vulnerable population, we conducted this study during the RSV season using dosing regimens that are expected to be effective.

Timeline

Start

2015-07-21

Primary completion

2017-07-05

Completion

2017-09-26

Outcome

Missed primary endpoint

paper There were no significant differences between primary endpoint rates (8.1%, placebo; 7.7%, 1-dose; 9.3%, 2-dose). PMID 32897368 ↗

release “evaluating suptavumab (REGN2222), an antibody to respiratory syncytial virus (RSV), did not meet its primary endpoint” regeneron.com ↗

Publications

• Simoes EAF, Forleo-Neto E, Geba GP, Kamal M, Yang F, Cicirello H, Houghton MR, Rideman R, Zhao Q, Benvin SL, Hawes A, Fuller ED, Wloga E, Pizarro JMN, Munoz FM, Rush SA, McLellan JS, Lipsich L, Stahl N, Yancopoulos GD, Weinreich DM, Kyratsous CA, Sivapalasingam S. Suptavumab for the Prevention of Medically Attended Respiratory Syncytial Virus Infection in Preterm Infants. Clin Infect Dis. 2021 Dec 6;73(11):e4400-e4408. doi: 10.1093/cid/ciaa951.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Suptavumab	Monoclonal antibody	30 mg/kg	Intramuscular

Indications