A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A

Phase 2 Terminated 2977 enrolled Vir Biotechnology, Inc.

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIR-2482 compared to placebo in preventing influenza A illness in healthy adults 18 to \<65 years of age without pre-existing risk factors for serious complications from influenza infection.

Timeline

Start: 2022-10-30
Primary completion: 2023-05-05
Completion: 2023-08-31

Outcome

Missed primary endpoint

Stopped: “VIR-2482 1200 mg did not demonstrate efficacy versus placebo in the primary analysis of the primary endpoint”

registry analysis (superiority test); VIR-2482 (1200 mg) vs Placebo; p = 0.5552; NCT05567783 ↗

paper VIR-2482 450 mg and 1200 mg prophylaxis did not reduce the risk of protocol-defined ILI with reverse transcriptase-polymerase chain reaction-confirmed influenza A versus placebo PMID 39036981 ↗

release “The Phase 2 PENINSULA (PrevEntioN of IllNesS DUe to InfLuenza A) trial evaluating VIR-2482 for the prevention of symptomatic influenza A illness did not meet primary or secondary efficacy endpoints.” vir.bio ↗

Publications

Tan SK, Cebrik D, Plotnik D, Agostini ML, Boundy K, Hebner CM, Yeh WW, Pang PS, Moya J, Fogarty C, Darani M, Hayden FG. A Randomized, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of VIR-2482 in Healthy Adults for Prevention of Influenza A Illness (PENINSULA). Clin Infect Dis. 2024 Oct 15;79(4):1054-1061. doi: 10.1093/cid/ciae368.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SONAVIBART	Monoclonal antibody	450 mg	Intramuscular
Subject	SONAVIBART	Monoclonal antibody	1200 mg	Intramuscular