SK bioscience(302440) has kicked off a global phase 1b clinical trial of a respiratory syncytial virus (RSV) preventive antibody in infants.
SK bioscience said on the 14th that it submitted a clinical trial application (CTA) to the South African Health Products Regulatory Authority (SAHPRA) for a global pediatric phase 1b study of the RSV preventive antibody candidate "RSM01," for which it received a technology transfer from the Bill & Melinda Gates Medical Research Institute (Gates MRI), a nonprofit medical research organization under the Gates Foundation.
The trial will enroll about 80 infants from 2 weeks to 8 months of age. It will evaluate the safety and pharmacokinetic characteristics of RSM01. The company plans to confirm the safety and in‑body characteristics of RSM01 in infants through this phase 1b and then proceed to late‑stage clinical development.
RSV is a virus that can cause severe lower respiratory tract infections, such as pneumonia and bronchiolitis, when it infects infants and young children. In particular, infants in the early months of life have underdeveloped immune systems and face a relatively higher risk of severe infection.
Preventive antibodies work differently from vaccines. While vaccines induce the body to produce its own antibodies through "active immunity," preventive antibodies are administered directly to expect immediate protective effects through "passive immunity." They are drawing attention because they can be used in infants, such as those in the early months of life, for whom there are limits to forming active immunity through vaccination.
This trial is meaningful in that it expands the development population from adults in early trials to infants. RSM01 was secured when SK bioscience signed a technology transfer agreement with Gates MRI in Feb. RSM01 has undergone early research and an adult phase 1a study at Gates MRI.
SK bioscience plans to expand its infectious disease prevention business, previously centered on vaccines, into the antibody field to broaden its portfolio. Following its cell culture influenza vaccine and protein‑conjugate pneumococcal vaccine, it is extending its development scope to an RSV preventive antibody.
Ahn Jae-yong, president of SK bioscience, said, "This is a meaningful achievement that advances next‑generation technology secured through global partnerships by combining it with our own R&D capabilities," and added, "We will continue to build diverse infectious disease prevention platforms and rise as a corporations competing globally."
Evaluate Pharma, a global market research firm, projected that the global RSV preventive antibody market will grow to $4.5 billion (about 6.3 trillion won) by 2032.