Introduction of CD388
CD388 aims to revolutionize the prevention of influenza by offering universal activity against all flu strains, not dependent on the host immune system, and combines a novel multivalent presentation of zanamivir with a human antibody fragment to prolong half-life.
Successful Phase 1 and Phase 2a Trials
Phase 1 single ascending dose study showed CD388 to be well tolerated with an extended half-life. Phase 2a human challenge study showed substantial protective efficacy, supporting its advancement to a phase 2b study.
Progress of NAVIGATE Phase 2b Study
NAVIGATE study completed dosing of 5,041 subjects by December, with top-line data expected by June. The study aims to determine dose selection for phase three.
Potential Phase 3 Study
Based on phase 2b results and FDA discussions, a phase 3 study is planned for February in high-risk comorbid and immune-compromised patients, addressing unmet needs.
R&D Day Announcement
An R&D day is planned for May 22 to provide updates on the NAVIGATE trial, regulatory discussions, and phase 3 plans, emphasizing the potential commercial opportunity for CD388.