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Read PublicationBackground
Influenza is a significant public health concern, especially in immunocompromised patients. CD388 is a novel multivalent zanamivir conjugate that is stably linked to a proprietary human immunoglobulin G1 Fc with a long half-life for prevention of influenza. Here we report a proof-of-concept study on the prophylactic activity of subcutaneously administered CD388 against influenza challenge.
Methods
In a randomized, double-blind, placebo-controlled, phase 2a human challenge study, a single dose of CD388 (50 or 150 mg) was subcutaneously administered in healthy participants 5 days before intranasal challenge with influenza A (H3N2). Safety, pharmacokinetics, infection rate (by reverse transcription–quantitative polymerase chain reaction methods [RT-qPCR]), intranasal viral load (VL), and symptoms were compared between the CD388 and placebo treatment groups.
Results
The area under the VL–time curve (VL-AUC), primary endpoint, was lower in the CD388 150 mg group (n = 28) compared with the placebo group (n = 28; mean 10.70 log10 [copies/mL] × days vs mean 16.09 log10 [copies/mL] × days; P = .0390). Peak VL and the rate of RT-qPCR–confirmed influenza infection were lower in the CD388 group versus the placebo group (P = .0185 and P = .0248, respectively). Clinical symptom scores were numerically lower among participants treated with CD388 compared with participants treated with placebo. There were a limited number of treatment-emergent adverse events. Anti-drug antibody development was rare and not clinically relevant.
Authors
This paper had multiple authors including Alex Mann and Alice Tourneroche
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