Salute e Benessere
ArkBio Initiates Phase II Clinical Trial of AK0610, a Preventive Monoclonal Antibody for Respiratory Syncytial Virus Infection
RSV is 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 at 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, are at 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.
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.
"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. The initiation of AK0610's Phase II clinical study is an important milestone in advancing such preventive strategies. Evaluating its safety and pharmacokinetics in healthy infants is an essential step towards developing this antibody for China as well as the global vast infant population. We are optimistic that the study will pave the way for this promising drug candidate to safeguard the healthy growth of infants globally."
"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. Together with participating centers across the nation, we are committed to conducting this clinical trial with scientific rigor with a goal to reduce the burden of RSV-related diseases among infants."
ArkBio is a global biotech company focused on developing innovative therapeutics for respiratory, infectious, and pediatric diseases. Founded in 2014, it 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.
ArkBio has established strategic partnerships with several multinational pharmaceutical companies and academic institutes, including Roche, Genentech, the Scripps Research Institute , the Institute of Microbiology of Chinese Academy of Sciences, domestic and international biotechnology companies, as well as venture capital institutions.
For more information, please visit: www.arkbiosciences.com
Investor Inquiries: IR@arkbiosciences.com
Logo - https://mma.prnewswire.com/media/2516404/ArkBio_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/arkbio-initiates-phase-ii-clinical-trial-of-ak0610-a-preventive-monoclonal-antibody-for-respiratory-syncytial-virus-infection-302598273.html