Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") announced today the successful enrollment and dosing of all participants in a Phase 1 clinical study of AK0610, a fully human monoclonal antibody designed to prevent respiratory syncytial virus (RSV) infection. This milestone marks a significant advancement in ArkBio' RSV portfolio, offering a new potential option for preventing RSV infection for vulnerable infants susceptible to RSV.

RSV is a globally prevalent and highly contagious RNA virus known for its seasonal epidemic patterns. It is one of the primary pathogens responsible for lower respiratory tract infections in children under five years worldwide and the leading cause of hospitalization among infants under one year of age. The virus spreads mainly through direct contact and airborne droplets, with a high rate of infection especially among children, leading to severe health consequences. High-risk individuals often experience more severe symptoms, frequently requiring hospitalization and, in some cases, facing fatal outcomes. RSV infection is also a significant risk factor for recurrent wheezing and asthma in children. The world faces a heavy healthcare burden and treatment challenges related to RSV infection.

AK0610 is a monoclonal antibody targeting the pre-fusion F protein of RSV that was isolated from a recovered infant and engineered. Compared to other RSV-neutralizing antibodies, AK0610 has a unique viral antigen binding epitope and novel mechanism of action. In preclinical studies, AK0610 demonstrated outstanding viral neutralization activity and an extended half-life that offers prolonged protection. It is positioned to become a new generation, long-acting preventive antibody against RSV-induced respiratory infections.

The Phase 1 study of AK0610 is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate safety, tolerability, and pharmacokinetics of AK0610 in healthy adults. All 136 participants successfully completed dosing with the maximum administered dose reaching 3000 mg. Most of the study participants have been followed for up to six months with no observed serious adverse events related to the drug and drug exposure reaching the anticipated effective protective concentration, suggesting a desired profile of safety, tolerability, and human pharmacokinetics in healthy subjects.

Dr. Jim Wu, CEO of ArkBio, stated, “The successful enrollment and dosing completion of all participants in Phase 1 clinical trial of AK0610 represents a significant step forward for ArkBio in the area of RSV prevention. We extend our sincere gratitude to all participants, physician team, and partners involved in this study for their efforts and contributions. ArkBio is dedicated to drug development for RSV treatment that is represented by our leading therapeutic drug ziresovir as well as RSV prevention. The completion of AK0610's Phase 1 enrollment and dosing is another significant milestone. Based on the current Phase 1 clinical data, we are encouraged that AK0610 will become a new generation, long-acting monoclonal antibody for RSV prevention. Prevention and treatment of RSV infection complement each other, especially for high-risk populations like infants, the elderly, and immunocompromised patients. This achievement motivates us to continue developing comprehensive and effective prevention and treatment solutions for high-risk and infected patients worldwide, advancing our progress in RSV drug development.”

About ArkBio

ArkBio is a global biotech company focusing on discovery and development of innovative drugs for unmet medical needs, especially in the therapeutic areas of respiratory, infectious, and pediatric diseases. Since its inception in 2014, the company has established core technology platforms and built an innovative and highly differentiated R&D pipeline through in-house R&D efforts and external collaborations. Our strong R&D pipeline includes innovative clinical and pre-clinical stage drug candidates with first- or best-in-class potential for global clinical development. As one of the core assets, ziresovir is the first direct-acting RSV antiviral drug that has been developed by ArkBio.

ArkBio has established strategic partnerships with several multinational pharmaceutical companies and academic institutes, including Roche, Genentech, the Scripps Research Institute, the Institute of Microbiology, Chinese Academy of Sciences, domestic and international biotechnology companies, as well as venture investment institutions. 

For more information about the company, please visit our website：www.arkbiosciences.com

Investor Inquiries：IR@arkbiosciences.com