Top-Line results from Phase III Study of Pfizer’s Abrysvo

Results from the Phase III clinical trial MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), evaluating a single dose of Abrysvo versus placebo in adults 18 to 59 years of age at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD), were released today by Pfizer (NYSE; PFE).

The US pharma giant noted that adults with certain underlying chronic conditions are at increased risk of developing, and being hospitalized for, RSV-associated LRTD. Among US adults 18 to 49 years of age, 9.5% have a chronic condition that puts them at risk of severe RSV disease and this percentage rises to 24.3% among persons 50 to 64 years of age.

Although Abrysvo and rival vaccine Arexvy from UK drug major GSK (LSE: GSK) received regulatory approvals as RSV treatment in older patients last year, no RSV vaccines have been approved for use in adults 18 to 59 years of age. The MONeT study was initiated to address this significant unmet need by investigating the immunogenicity and safety of Abrysvo in adults aged 18 to 59 at increased risk for RSV disease, such as those with asthma, diabetes, and chronic obstructive pulmonary disease.