Overview

• The NAVIGATE Phase 2b trial enrolled more than 5,000 healthy adults in the US and UK and met all primary and secondary endpoints for CD388.
• A single 450 mg injection yielded 76.1% prevention efficacy against symptomatic, laboratory-confirmed influenza (p < .0001) with combined higher-dose groups showing 68.6% efficacy.
• CD388 maintained durable prophylactic effects through 28 weeks and demonstrated significant protection based on fever thresholds of 37.8 °C and 37.2 °C.
• Safety assessments showed no drug-related serious adverse events and tolerability similar to placebo, including only mild injection site reactions.
• Cidara has initiated FDA engagement and plans to advance CD388, a broad-spectrum drug-Fc conjugate, into Phase 3 development.