IBIO123 / Immune Biosolutions - LARVOL DELTA

Emerging anti-spike monoclonal antibodies against SARS-CoV-2. (PubMed, Expert Opin Biol Ther) - "Strategies to potentially mitigate this are discussed. Based on prior successful experience, immunocompromised patients will certainly benefit from the utilization of mAbs for the prevention and treatment of COVID-19; thus, we need to design potential interventions to ensure the sustained activity of these agents."

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

Phase 1&2 Study to Evaluate the Safety & Efficacy of Inhaled IBIO123 in Severe COVID-19 Illness (clinicaltrials.gov) - P1/2 | N=123 | Completed | Sponsor: Immune Biosolutions Inc | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Safety and efficacy of inhaled IBIO123 for mild-to-moderate COVID-19: a randomised, double-blind, dose-ascending, placebo-controlled, phase 1/2 trial. (PubMed, Lancet Infect Dis) - P1/2 | "Inhalation of IBIO123 was safe. Despite the lack of significant reduction of viral load at day 5, treatment with IBIO123 resulted in a higher proportion of participants with complete resolution of respiratory symptoms at day 8. This study supports further clinical research on inhaled monoclonal antibodies in COVID-19 and respiratory diseases in general."

Journal • P1/2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 1&2 Study to Evaluate the Safety & Efficacy of Inhaled IBIO123 in Severe COVID-19 Illness (clinicaltrials.gov) - P1/2 | N=123 | Active, not recruiting | Sponsor: Immune Biosolutions Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

Study in Adults to Assess the Safety and Efficacy of Inhaled IBIO123, for Post-exposure Prophylaxis of COVID-19 (clinicaltrials.gov) - P2 | N=200 | Completed | Sponsor: Immune Biosolutions Inc | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Study in Adults to Assess the Safety and Efficacy of Inhaled IBIO123, for Post-exposure Prophylaxis of COVID-19 (clinicaltrials.gov) - P2 | N=200 | Active, not recruiting | Sponsor: Immune Biosolutions Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

Study in Adults to Assess the Safety and Efficacy of Inhaled IBIO123, for Post-exposure Prophylaxis of COVID-19 (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Immune Biosolutions Inc | Not yet recruiting ➔ Recruiting | N=140 ➔ 200

Enrollment change • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Phase 1&2 Study to Evaluate the Safety & Efficacy of Inhaled IBIO123 in Severe COVID-19 Illness (clinicaltrials.gov) - P1/2 | N=166 | Recruiting | Sponsor: Immune Biosolutions Inc | Trial completion date: Mar 2023 ➔ Jun 2023 | Trial primary completion date: Mar 2023 ➔ Jun 2023

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Phase 1/2 Study to Evaluate the Efficacy and Safety of Inhaled IBIO123 in Participants With Mild to Moderate COVID-19 Illness (clinicaltrials.gov) - P1/2 | N=162 | Completed | Sponsor: Immune Biosolutions Inc | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Study in Adults to Assess the Safety and Efficacy of Inhaled IBIO123, for Post-exposure Prophylaxis of COVID-19 (clinicaltrials.gov) - P2 | N=140 | Not yet recruiting | Sponsor: Immune Biosolutions Inc

New P2 trial • Infectious Disease • Novel Coronavirus Disease

Phase 1/2 Study to Evaluate the Efficacy and Safety of Inhaled IBIO123 in Participants With Mild to Moderate COVID-19 Illness (clinicaltrials.gov) - P1/2 | N=224 | Recruiting | Sponsor: Immune Biosolutions Inc | Trial primary completion date: Sep 2022 ➔ Jan 2023

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Phase 1&2 Study to Evaluate the Safety & Efficacy of Inhaled IBIO123 in Severe COVID-19 Illness (clinicaltrials.gov) - P1/2 | N=216 | Recruiting | Sponsor: Immune Biosolutions Inc | Trial completion date: Nov 2022 ➔ Mar 2023 | Trial primary completion date: Sep 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Phase 1&2 Study to Evaluate the Safety & Efficacy of Inhaled IBIO123 in Severe COVID-19 Illness (clinicaltrials.gov) - P1/2 | N=216 | Recruiting | Sponsor: Immune Biosolutions Inc

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

Phase 1/2 Study to Evaluate the Efficacy and Safety of Inhaled IBIO123 in Participants With Mild to Moderate COVID-19 Illness (clinicaltrials.gov) - P1/2 | N=224 | Recruiting | Sponsor: Immune Biosolutions Inc

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease