Safety and efficacy of inhaled IBIO123 for mild-to-moderate COVID-19: a randomised, double-blind, dose-ascending, placebo-controlled, phase 1/2 trial
Dr Bruno Maranda, PhD, M Lurquin BSc, P Brabant RN, A Fugère MSc Sébastien M Labbé, Magali Lurquin, Pascal Brabant, Alexandre Fugère, Jean-François Larrivée, PhD, A Leroux BSc Djordje Grbic, Annie Leroux, PhD Frédéric Leduc, Prof Andrés Finzi, PhD Simon Gaudreau, Yolandi Swart
The Lancet Infectious Diseases, doi:10.1016/s1473-3099(23)00393-6
Background COVID-19 severity is associated with its respiratory manifestations. Neutralising antibodies against SARS-CoV-2 administered systemically have shown clinical efficacy. However, immediate and direct delivery of neutralising antibodies via inhalation might provide additional respiratory clinical benefits. IBIO123 is a cocktail of three, fully human, neutralising monoclonal antibodies against SARS-CoV-2. We aimed to assess the safety and efficacy of inhaled IBIO123 in individuals with mild-to-moderate COVID-19.
Methods This double-blind, dose-ascending, placebo-controlled, first-in-human, phase 1/2 trial recruited symptomatic and non-hospitalised participants with COVID-19 in South Africa and Brazil across 11 centres. Eligible participants were adult outpatients (aged ≥18 years; men and non-pregnant women) infected with COVID-19 (first PCR-confirmed within 72 h) and with mild-to-moderate symptoms, the onset of which had to be within 10 days of randomisation. Using permuted blocks of four, stratified by site, we randomly assigned participants (1:3) to receive single-dose placebo or IBIO123 (1 mg, 5 mg, or 10 mg) in phase 1, and single-dose placebo or IBIO123 (10 mg) in phase 2, in addition to local standard of care. Participants underwent serological testing to identify antibodies against SARS-CoV-2. Participants, investigators, and the study team were masked to treatment assignment. In phase 1, the primary outcome was the safety assessment in the safety population (ie, all participants who received an intervention). In phase 2, the primary outcome was the mean absolute change from baseline to day 5 in SARS-CoV-2 viral load measured by nasopharyngeal swabs analysed using a mixed model for repeated measures in the full analysis set (FAS; ie, participants with one analysable viral load value at baseline and at least one analysable viral load value at day 3 or day 5). Secondary clinical outcomes included safety from baseline to day 29, assessed by evaluating adverse events; the effect of IBIO123 on baseline COVID-19 symptoms resolution until day 6, with symptoms systemically evaluated by the investigators; and disease progression as measured by the COVID-19 WHO Clinical Progression Scale. For clinical endpoints in phase 2, we used a modified FAS (ie, participants who had at least one analysable viral load value over the course of the study, confirming that they were infected with SARS-CoV-2). This trial is now completed and is registered with ClinicalTrials.gov, NCT05298813. Findings Between Dec 4, 2021, and May 23, 2022, 24 participants were enrolled in phase 1. Between July 20, 2022, and Jan 4, 2023, 138 participants were enrolled in phase 2 and five were excluded because they did not meet the inclusion criteria. Participants were randomly assigned to receive IBIO123 (n=18) or placebo (n=6) in phase 1, and randomly assigned to receive IBIO123 (n=104) or placebo (n=34) in phase 2. In phase 2, the study was stopped before reaching the..
References
Abebe, Dejenie, Protective roles and protective mechanisms of neutralizing antibodies against SARS-CoV-2 infection and their potential clinical implications, Front Immunol
Behr, Maddox, Epstein, Orav, Barnett, Anti-SARS-CoV-2 monoclonal antibody distribution to high-risk medicare beneficiaries, 2020-2021, JAMA
Butler, Hobbs, Gbinigie, Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial, Lancet
Chatterjee, Jensen, Harris, Admission respiratory status predicts mortality in COVID-19, Influenza Other Respir Viruses
Chen, Bobrovitz, Premji, Koopmans, Fisman et al., SARS-CoV-2 shedding dynamics across the respiratory tract, sex, and disease severity for adult and pediatric COVID-19, eLife
Chen, Nirula, Heller, SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with COVID-19, N Engl J Med
Chow, Pan, Seow, Lam, Inhalable neutralizing antibodies-promising approach to combating respiratory viral infections, Trends Pharmacol Sci
Guan, Ni, Hu, Clinical characteristics of coronavirus disease 2019 in China, N Engl J Med
Guilleminault, Azzopardi, Arnoult, Fate of inhaled monoclonal antibodies after the deposition of aerosolized particles in the respiratory system, J Control Release
Gungor, Nematollahi, Effectiveness of casirivimab-imdevimab monoclonal antibody treatment among high-risk patients with severe acute respiratory syndrome coronavirus 2 B.1.617.2 (delta variant) infection, Open Forum Infect Dis
Hammond, Leister-Tebbe, Gardner, Oral nirmatrelvir for high-risk, nonhospitalized adults with COVID-19, N Engl J Med
Huang, Wang, Li, Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China, Lancet
Hui, Ho, Cheung, SARS-CoV-2 omicron variant replication in human bronchus and lung ex vivo, Nature
Hurlburt, Homad, Sinha, Structural definition of a pan-sarbecovirus neutralizing epitope on the spike S2 subunit, Commun Biol
Kip, Mccreary, Collins, Evolving real-world effectiveness of monoclonal antibodies for treatment of COVID-19: a cohort study, Ann Intern Med
Levin, Ustianowski, Wit, Intramuscular AZD7442 (tixagevimab-cilgavimab) for prevention of COVID-19, N Engl J Med
Li, Chen, Prévost, Structural basis and mode of action for two broadly neutralizing antibodies against SARS-CoV-2 emerging variants of concern, Cell Rep
Matthews, A cocktail of antibodies for COVID-19 therapy, Nat Rev Immunol
Matthews, Ee, Ge, Developing inhaled protein therapeutics for lung diseases, Mol Biomed
Murugapandian, Gungor, Al-Obaidi, Effectiveness of casirivimab-imdevimab and sotrovimab monoclonal antibody treatment among high-risk patients with SARS-CoV-2 infection: a real-world experience, medRxiv,
doi:10.1101/2022.12.23.22283921(preprintNichols, Deveau, Upadhyaya, Bebtelovimab: considerations for global access to treatments during a rapidly evolving pandemic, Lancet Infect Dis
Parray, Shukla, Perween, Inhalation monoclonal antibody therapy: a new way to treat and manage respiratory infections, Appl Microbiol Biotechnol
Prévost, Ullah, Molecular basis for antiviral activity of two pediatric neutralizing antibodies targeting SARS-CoV-2 spike RBD, iScience
Tomasicchio, Jaumdally, Pooran, SARS-CoV-2 viral replication persists in the human lung for several weeks after onset of symptomatic severe COVID-19 and is associated with attenuated pulmonary immunity and variant-specific clinical sequalae, medRxiv,
doi:10.1101/2023.03.06.23286834Ullah, Prévost, Ladinsky, Live imaging of SARS-CoV-2 infection in mice reveals that neutralizing antibodies require Fc function for optimal efficacy, Immunity
Weinreich, Sivapalasingam, Norton, REGEN-COV antibody combination and outcomes in outpatients with COVID-19, N Engl J Med
Weinreich, Sivapalasingam, Norton, REGN-COV2, a neutralizing antibody cocktail, in outpatients with COVID-19, N Engl J Med
Yang, Li, Song, Ying, Wu, Inhalable antibodies for the treatment of COVID-19, Innovation (Camb)
Zhang, Stacey, Agostino, Tugg, Marzok et al., Beyond neutralization: Fc-dependent antibody effector functions in SARS-CoV-2 infection, Nat Rev Immunol
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{
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