RSV is a common and highly contagious ribonucleic acid virus with seasonal outbreaks, posing a significant threat to children under five years. Credit: REC Stock Footage/Shutterstock.

Shanghai Ark Biopharmaceutical (ArkBio) has concluded enrolment and dosing for a Phase I trial of fully human monoclonal antibody, AK0610, to prevent respiratory syncytial virus (RSV) infection, particularly in vulnerable infants.

This marks an advancement to the company’s RSV portfolio, by offering a new therapy option for infants at high risk of RSV.

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AK0610 is engineered from an antibody isolated from a recovered infant and targets the pre-fusion F protein of RSV. It has a unique viral antigen binding epitope and a new mechanism of action.

Preclinical studies showed the antibody to have superior viral neutralisation capabilities and an extended half-life, indicating its potential as a long-acting preventive antibody against RSV-induced respiratory infections.

The double-blind, placebo-controlled trial was structured to assess the pharmacokinetics, safety, and tolerability of the therapy in healthy adult individuals.

With all 136 subjects having concluded dosing, the highest administered dose reached 3000mg. Follow-up for up to six months revealed no serious adverse events related to the drug, and drug exposure reached the expected effective protective concentration.

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ArkBio CEO Dr Jim Wu said: “The successful enrolment and dosing completion of all participants in Phase I 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 I enrolment and dosing is another significant milestone. Based on the current Phase I clinical data, we are encouraged that AK0610 will become a new generation, long-acting monoclonal antibody for RSV prevention.”

RSV is a common and highly contagious ribonucleic acid (RNA) virus with seasonal outbreaks, posing a significant threat to children under five years.

It also increases the risk of asthma and recurrent wheezing in children.