SK Bioscience files for global Phase 1b trial of RSV preventive antibody

SK Bioscience is accelerating the development of next-generation infectious disease prevention technologies through global partnerships, expanding its portfolio beyond vaccines into antibody-based preventive medicines.

SK Bioscience said Friday it had submitted a clinical trial application to South Africa's Health Products Regulatory Authority for a global pediatric Phase 1b trial of RSM01, a respiratory syncytial virus preventive antibody candidate licensed from Gates MRI, a nonprofit medical research organization under the Bill & Melinda Gates Foundation.

The trial will enroll about 80 infants between 2 weeks and 8 months of age to evaluate RSM01's safety and pharmacokinetic profile. The study extends the evaluation from a completed adult Phase 1a trial to infants and young children — the primary target population for RSV prevention.

RSV is a leading cause of severe lower respiratory tract infections in infants and young children. Because newborns have immature immune systems, vaccines are less effective at generating immunity in the earliest months of life. Preventive antibody technology — which delivers antibodies directly to provide immediate passive immunity — has emerged as a key alternative. According to market research firm Evaluate Pharma, the global RSV preventive antibody market is projected to reach $4.5 billion by 2032.

With RSM01 now added to its existing cell-culture influenza vaccine and pneumococcal vaccine, SK Bioscience is building out its respiratory disease capabilities.

The clinical trial application is expected to serve as a milestone in the company's R&D transformation — accelerating its push into next-generation biotech modalities such as antibody therapeutics and preventives while deepening collaboration with global health organizations.

"This is the result of combining next-generation technology secured through global partnerships with our own R&D capabilities," SK Bioscience President Ahn Jae-yong said. "We will continue to build out a diverse range of infectious disease prevention platforms to strengthen our global competitiveness."

SK Bioscience has been broadening its global R&D network on multiple fronts — co-developing a pneumococcal vaccine with Sanofi, collaborating with Gates MRI on RSV prevention technology, and licensing injectable rotavirus vaccine technology from the US Centers for Disease Control and Prevention.