Shanghai Ark Biopharmaceutical Co., Ltd. has initiated a Phase II clinical study of AK0610, a fully human monoclonal antibody designed to prevent respiratory syncytial virus (RSV) infection in infants. The milestone represents a significant advancement in RSV prevention and expands the company's innovative anti-RSV drug portfolio.
Clinical Trial Design and Leadership
The multicenter, randomized, double-blind, placebo-controlled, dose-escalation Phase II study will assess the safety, tolerability, and pharmacokinetics of AK0610 Injection in healthy infants in China. The study will be conducted at five centers nationwide, jointly led by Professor Xin Ni of Beijing Children's Hospital, Capital Medical University, and Professor Hanmin Liu of West China Second Hospital, Sichuan University.
RSV Disease Burden and Clinical Need
RSV represents a leading cause of acute lower respiratory tract infections (ALRTI) in children under 5 years of age worldwide. More than 80% of children become infected before their first birthday, and nearly all have been exposed by age two. Among those infected, approximately one-third may develop severe ALRTI, such as bronchiolitis or pneumonia.
Infants under one year of age, particularly preterm infants, face the greatest risk of developing serious RSV-related complications, often requiring hospitalization. Given China's large infant population and persistent RSV prevalence, the country faces a significant healthcare burden, underscoring the urgent need for novel, long-acting preventive interventions.
AK0610 Mechanism and Preclinical Profile
AK0610 is a monoclonal antibody targeting the pre-fusion F protein of RSV. The antibody was isolated from a convalescent infant and subsequently engineered to enhance durability. Distinguished by its unique binding epitope and mechanism of action, AK0610 maintains robust neutralizing activity across RSV variants, especially RSV B strains.
Preclinical data demonstrated strong antiviral activity with an excellent safety profile. In the completed Phase I trial in healthy adults, AK0610 was safe, well-tolerated, and exhibited favorable pharmacokinetic properties. With an extended half-life, a single dose may provide season-long protection, positioning AK0610 as a promising new-generation long-acting antibody for prophylaxis of RSV infection in infants.
Expert Perspectives
Professor Xin Ni emphasized the clinical significance of the development: "RSV remains the leading viral cause of hospitalization among infants and young children in China, especially those under one year of age, placing a heavy burden on families and the healthcare system. There is an urgent need for domestically developed innovative preventive antibodies capable of offering durable protection throughout the RSV season."
Professor Hanmin Liu highlighted the antibody's clinical potential: "AK0610 is a fully human monoclonal antibody with a unique mechanism of action and excellent clinical potential. Its potent, highly specific neutralizing activity and extended half-life make it a strong candidate for RSV prevention. The rigorously designed Phase II study will provide important data on its safety and pharmacokinetic characteristics in infants, establishing a solid foundation for future pivotal trials."
Company Background
ArkBio is a global biotech company focused on developing innovative therapeutics for respiratory, infectious, and pediatric diseases. Founded in 2014, the company has built core technology platforms and a differentiated R&D pipeline through in-house R&D efforts and external collaboration. Key drug assets include ziresovir (AK0529), the first direct-acting RSV antiviral with positive pivotal Phase III results, and AK0901, an ADHD therapeutic drug, both of which have filed NDA to China CDE for market approval.
