• Ocugen's OCU500, a novel inhaled mucosal vaccine for COVID-19, has received IND clearance from the FDA, allowing a Phase 1 clinical trial to proceed.
• The Phase 1 trial, sponsored by NIAID, will assess the safety, tolerability, and immunogenicity of OCU500 administered via inhalation and intranasally.
• OCU500 utilizes a chimpanzee adenovirus-vectored (ChAd36) technology and aims to provide more durable and safer protection against COVID-19 variants.
• The trial anticipates starting in Q2 2025 and will enroll 80 adult subjects aged 18 to 64 years, with results expected to support further development.