VIR-2482 / Vir Biotech - LARVOL DELTA

Monoclonal antibodies against influenza viruses: a clinical trials review. (PubMed, Front Immunol) - "MHAA4549A demonstrated a 97.5% reduction in viral load in H3N2 models and showed synergistic effects with oseltamivir in severe cases. However, despite preclinical promise, others, such as VIR-2482 (intramuscular) and MEDI8852, failed in Phase 2 trials...mAbs hold promise for high-risk groups and pandemics but require further engineering to enhance efficacy and overcome biological barriers. Refinements in administration and design could establish monoclonal antibodies (mAbs) as a key tool in the management of influenza."

Journal • Review • Gastrointestinal Disorder • Infectious Disease • Influenza • Pain • Respiratory Diseases

Polyclonal and Monoclonal Antibodies for the Treatment and Prevention of Influenza. (PubMed, J Infect Dis) - "The COVID-19 pandemic demonstrated that these approaches, especially monoclonal antibodies, may have unique potential in certain stages of disease and populations, especially in preventing severe disease in a population without preexisting immunity or in those with a limited capacity to mount an effective humoral immune response. This review summarizes past and ongoing efforts in using monoclonal and polyclonal antibodies for the treatment and prevention of influenza, focusing on products that have entered clinical trials and drawing lessons from COVID-19 to direct future efforts on these strategies."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Randomized, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of VIR-2482 in Healthy Adults for Prevention of Influenza A Illness (PENINSULA). (PubMed, Clin Infect Dis) - "VIR-2482 1200 mg IM was well tolerated but did not significantly prevent protocol-defined ILI. Secondary endpoint analyses suggest this dose may have reduced influenza A illness."

Journal • Infectious Disease • Influenza • Respiratory Diseases

A phase 1 study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics of VIR-2482: a monoclonal antibody for the prevention of severe influenza A illness. (PubMed, Antimicrob Agents Chemother) - P1 | "The safety, tolerability, and pharmacokinetic profile of VIR-2482 at doses up to 1,800 mg supported its further investigation as a long-acting antibody for the prevention of influenza A illness. This study has been registered at ClinicalTrials.gov under identifier NCT04033406."

Clinical • Journal • P1 data • PK/PD data • Infectious Disease • Influenza • Respiratory Diseases

A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A (clinicaltrials.gov) - P2 | N=2985 | Terminated | Sponsor: Vir Biotechnology, Inc. | Trial completion date: Jul 2024 ➔ Aug 2023 | Active, not recruiting ➔ Terminated; VIR-2482 did not achieve its primary efficacy endpoint in the prevention of seasonal Influenza A illness via intramuscular administration.

Trial completion date • Trial termination • Infectious Disease • Influenza • Respiratory Diseases

A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A (clinicaltrials.gov) - P2 | N=3000 | Active, not recruiting | Sponsor: Vir Biotechnology, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A (clinicaltrials.gov) - P2 | N=3000 | Recruiting | Sponsor: Vir Biotechnology, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A (clinicaltrials.gov) - P2 | N=3000 | Not yet recruiting | Sponsor: Vir Biotechnology, Inc.

New P2 trial • Infectious Disease • Influenza • Respiratory Diseases

Study of VIR-2482 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=100 | Completed | Sponsor: Vir Biotechnology, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases

Study of VIR-2482 in Healthy Volunteers (clinicaltrials.gov) - P1; N=100; Active, not recruiting; Sponsor: Vir Biotechnology, Inc.; Enrolling by invitation ➔ Active, not recruiting; Phase classification: P1/2 ➔ P1; N=2860 ➔ 100; Trial primary completion date: Dec 2020 ➔ Nov 2021

Clinical • Enrollment change • Enrollment closed • Phase classification • Trial primary completion date • Infectious Disease • Respiratory Diseases

Study of VIR-2482 in Healthy Volunteers (clinicaltrials.gov) - P1/2; N=2860; Enrolling by invitation; Sponsor: Vir Biotechnology, Inc.; Active, not recruiting ➔ Enrolling by invitation

Clinical • Enrollment open • Infectious Disease

[VIRTUAL] VIR-2482: A potent and broadly neutralizing antibody for the prophylaxis of influenza A illness (IDWeek 2020) - "The attributes of potency, broad recognition of a highly conserved epitope, retention of high-level effector functions in addition to half-life extension support the development of VIR-2482 as a universal prophylactic for influenza A illness."

Infectious Disease

[VIRTUAL] Preliminary safety and pharmacokinetic profile of VIR-2482: a monoclonal antibody for the prevention of influenza A illness (IDWeek 2020) - "Based on available data, VIR-2482 has been well tolerated following single IM doses of up to 1800 mg in healthy subjects. The preliminary PK profile of VIR-2482 enables once per season dosing. Overall, these data support initiation of a Phase 2 study to evaluate efficacy of VIR-2482 for the prevention of influenza A illness."

Clinical • PK/PD data • Infectious Disease

[VIRTUAL] VIR2482: a potent and broadly neutralizing antibody for the prophylaxis of influenza A illness (ECCMID 2020) - No abstract available

Infectious Disease

Study of VIR-2482 in Healthy Volunteers (clinicaltrials.gov) - P1/2; N=2860; Active, not recruiting; Sponsor: Vir Biotechnology, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease

Study of VIR-2482 in Healthy Volunteers (clinicaltrials.gov) - P1/2; N=2860; Recruiting; Sponsor: Vir Biotechnology, Inc.; Not yet recruiting ➔ Recruiting; Trial completion date: May 2021 ➔ Jan 2022

Clinical • Enrollment open • Trial completion date