Shanghai Ark Biopharmaceutical Co., Ltd., also referred to as ArkBio, has announced the start of a Phase II clinical trial for AK0610, a fully human monoclonal antibody aimed at preventing respiratory syncytial virus (RSV) infection in babies. This development is a significant milestone for ArkBio’s research focused on RSV and adds to its growing range of innovative treatments for the virus. Leveraging previous clinical experience, the company is working to offer a long-lasting preventive solution to tackle this widespread and serious infection.

The Phase II trial is a multi-site, randomized, double-blind, placebo-controlled study with a dose-escalation approach. It will assess the safety, how well the body tolerates the drug, and how it moves through the body in healthy infants across China. Five top hospitals are involved, including Beijing Children’s Hospital, Capital Medical University, led by Professor Xin Ni, and West China Second Hospital, Sichuan University, directed by Professor Hanmin Liu. The trial’s design is meant to gather reliable data that will help in further developing the antibody.

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RSV is a major cause of severe respiratory infections in children younger than five, with most children getting infected before their second birthday. Around one-third of those who get infected could develop serious conditions like bronchiolitis or pneumonia. Infants under one year, especially those born prematurely, are at the highest risk and often need hospital care. In China, where there is a large number of infants and ongoing RSV cases, the health burden is significant, emphasizing the need for effective, long-term prevention methods.

AK0610 targets the pre-fusion F protein of RSV and was originally found in a recovering infant. It has been modified to last longer in the body and shows strong ability to neutralize the virus, especially the RSV B strains. Early research showed strong antiviral effects with a good safety record. The Phase I trial in healthy adults found that AK0610 is safe, well-tolerated, and has favorable properties in how the body processes it, supporting its use as a preventive treatment for infants over a whole season.

Professor Xin Ni highlighted the urgent need for effective RSV prevention, stating that the virus is the primary cause of hospitalizations in young children in China and strains both families and the healthcare system. He called the beginning of the Phase II trial an important step in creating a durable preventive antibody. Professor Hanmin Liu noted that AK0610 has strong clinical potential because of its specific neutralizing ability and extended time in the body. He mentioned that the study will gather essential safety and absorption data, setting the stage for future key trials, and expressed a commitment to conducting the research thoroughly to lessen the impact of RSV on infants health.

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