Ocugen, Inc. announced that the U.S. Food and Drug Administration (FDA) has reviewed and cleared its Investigational New Drug (IND) application for OCU500, an inhaled mucosal vaccine candidate for COVID-19. This critical regulatory step allows for the initiation of a Phase 1 clinical trial. The National Institute of Allergy and Infectious Diseases (NIAID) will sponsor and conduct this trial.
The Phase 1 trial will assess the safety, tolerability, and immunogenicity of OCU500 when administered via two different routes: inhalation into the lungs and intranasally as a spray. NIAID, with funding from Project NextGen, will cover the full cost of the Phase 1 clinical trial, including operations and related analysis. This arrangement significantly de-risks the early development of OCU500 for Ocugen.
OCU500 is based on a novel chimpanzee adenovirus-vectored (ChAd36) technology, which has shown potential for increased mucosal and systemic antibodies and durable immune responses in earlier studies. The trial will enroll 80 adult subjects aged 18 to 64 years. Ocugen intends to expand this mucosal platform to address other serious respiratory threats, including seasonal influenza, bird flu, and respiratory syncytial virus (RSV).
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