MRI RSM01 / Bill & Melinda Gates Foundation - LARVOL DELTA

Replacing serum with dried blood microsampling for pharmacokinetics, viral neutralisation and immunogenicity bioanalysis supporting future paediatric development of RSM01, a candidate respiratory syncytial virus neutralising monoclonal antibody. (PubMed, BMC Infect Dis) - P1 | "Both RSM01 concentrations and RSV neutralising activity showed a strong correlation between the serum and blood measurements. ADA measurements also had an agreement of > 90% for individual samples and overall participant status. Our results demonstrate that dried blood is a suitable specimen type for collection and evaluation in the RSM01 clinical development program and shows promise as a useful approach to reduce patient burden in clinical trials, particularly for infants in low- and middle-income countries."

Clinical • Journal • PK/PD data • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSM01, a novel respiratory syncytial virus monoclonal antibody: preclinical characterization and results of a first-in-human, randomised clinical trial. (PubMed, BMC Infect Dis) - P1 | "RSM01 is a highly potent, half-life-extended, RSV-neutralising mAb candidate that was shown to be well tolerated in healthy adults. The rate of ADA to RSM01 was low. The long half-life of RSM01 and pharmacokinetics profile support further development of RSM01 as a potential single dose per season prophylaxis to prevent RSV disease in infants."

Journal • P1 data • Preclinical • Infectious Disease • Novel Coronavirus Disease • Pain • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSV Neutralizing Antibodies in Dried Blood. (PubMed, J Infect Dis) - P1 | "We demonstrated the feasibility of measuring RSV neutralization using dried blood as a patient-centered solution that may replace serology testing in trials against RSV or other viruses, such as influenza and SARS-CoV-2. Clinical Trials Registration.  NCT05118386 (ClinicalTrials.gov)."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSV neutralizing antibodies in dried blood. (PubMed, J Infect Dis) - "We demonstrated the feasibility of measuring RSV neutralization using dried blood as a patient-centered solution that may replace serology testing in trials against RSV or other viruses, such as influenza and SARS-CoV-2."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Pharmacokinetics and Safety in Healthy Adults of RSM01, a Novel RSV Monoclonal Antibody, and Population PK Modeling to Support Pediatric Development (IDWeek 2023) - No abstract available

Clinical • PK/PD data • Infectious Disease

Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Bill & Melinda Gates Medical Research Institute | Recruiting ➔ Completed | Trial primary completion date: Nov 2022 ➔ Aug 2022

Trial completion • Trial primary completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Bill & Melinda Gates Medical Research Institute | Trial completion date: Oct 2022 ➔ Jan 2023

Trial completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Bill & Melinda Gates Medical Research Institute | Trial primary completion date: May 2022 ➔ Oct 2022

Trial primary completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: Bill & Melinda Gates Medical Research Institute; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections