SK Bioscience Begins Infant Trial of Gates-Backed RSV Antibody in South Africa

What happened

SK bioscience submitted an application to SAHPRA to enroll about 80 infants aged 2 weeks to 8 months in a Phase 1b trial of the RSV preventive antibody RSM01. The trial evaluates safety and pharmacokinetics. The antibody was licensed from the Gates Medical Research Institute in February.

Why it matters

This marks the first clinical evaluation of RSM01 in infants following adult trials. It represents a milestone for SK bioscience's expansion into antibody-based infectious disease prevention. The global market for RSV preventive antibodies is projected to reach $4.5 billion by 2032.