Commercial-stage biopharmaceutical company Shanghai Ark Biopharmaceutical Co Ltd ('ArkBio') announced on Monday that the US Food and Drug Administration (FDA) has granted its investigational new drug (IND) application for AK0406, a long-acting antiviral drug-Fc conjugate (AFC).

This enables the company to launch a phase II clinical trial for influenza prevention in the United States.

A novel AFC drug, AK0406 precisely conjugates multiple potent small-molecular antivirals to an antibody Fc domain. It is designed to integrate direct antiviral activity with Fc-mediated immune clearance to prevent influenza, with potential therapeutic applications.

In preclinical studies, the drug demonstrated wide range and highly potent antiviral activity against both influenza A and B strains. It has also been optimised for its pharmacokinetics (PK) properties and GMP manufacturing process.

The primary objective of the US phase II clinical trial, a multicentre, randomised, double-blind, placebo-controlled study, is to evaluate AK0406 for influenza prevention. The study will also assess safety, tolerability, PK and immunogenicity.