Shanghai Ark Biopharmaceutical (ArkBio) has commenced a randomised Phase II study to evaluate the fully human monoclonal antibody, AK0610, for the prevention of respiratory syncytial virus (RSV) infection.
Globally, RSV is recognised as a primary cause of acute lower respiratory tract infections among paediatric patients under five years of age.
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The double-blind, multi-centre, placebo-controlled, dose escalation trial will investigate the tolerability, safety, and pharmacokinetic (PK) profile of the antibody injection in healthy Chinese infants.
It will take place across five different locations, coordinated by professor Xin Ni from Beijing Children’s Hospital at Capital Medical University and professor Hanmin Liu from West China Second Hospital, Sichuan University.
Ni said: “The initiation of AK0610’s Phase II clinical study is an important milestone in advancing such preventive strategies. Evaluating its safety and PK 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.”
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By GlobalDataInfants less than one year old, particularly those born prematurely, face the highest risk for severe complications from RSV, often necessitating hospital care.
The antibody targets the pre-fusion F protein of the virus. The antibody was originally sourced from a recovering infant and modified to extend its durability.
According to ArkBio, the antibody retains strong neutralising capabilities against multiple RSV strains, especially RSV B.
Liu said: “AK0610 is a fully human monoclonal antibody with a unique mechanism of action and excellent clinical potential. Its potent, highly specific neutralising 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 PK characteristics in infants, establishing a solid foundation for future pivotal trials.”
In the previous Phase I study involving the healthy adult population, the antibody demonstrated good tolerability and favourable PK characteristics.
Last year, ArkBio completed enrolment and dosing in the Phase I trial of AK0610 to prevent RSV infection in vulnerable infants.
