SK Bioscience Seeks Global RSV Antibody Trial

SK Bioscience has announced its submission of a clinical trial application for a global Phase 1b trial focusing on a respiratory syncytial virus (RSV) preventive antibody candidate, RSM01. The trial, planned for about 80 infants aged between two weeks and eight months, will be conducted under the South African Health Products Regulatory Authority (SAHPRA).

RSV is a significant cause of severe lower respiratory tract infections in infants and toddlers, especially among those with immature immune systems who struggle to develop active immunity through vaccines.

The Phase 1b trial is crucial as it broadens the development scope of RSM01, initially validated in adults, to infants, the primary targets for prevention. SK Bioscience secured the technology for RSM01 from Gates MRI, a non-profit medical research institute under the Gates Foundation, following a technology transfer agreement in February. The company plans to use this trial to verify the potential for clinical development and establish a foundation for later-stage trials.

The global RSV preventive antibody market is projected to reach $4.5 billion, or approximately 6.3 trillion won, by 2032, according to global market research firm Evaluate Pharma. SK Bioscience is expanding its product lineup to include the RSV preventive antibody, following the success of its cell-cultured influenza vaccine and protein conjugate pneumococcal vaccine.

SK Bioscience CEO Ahn Jae-yong highlighted the achievement of advancing next-generation technology through global partnerships, combined with the company's own research and development capabilities, and expressed confidence in the company's global competitiveness by securing various infectious disease prevention platforms.