Ocugen, Inc. announced that the FDA has cleared an IND for a Phase 1 trial of OCU500 vaccine for the prevention of COVID-19, which the company licensed from Washington University in St. Louis in 2022. The trial, which will evaluate inhaled and intranasal administration of the vaccine, will be conducted by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) as part of Project NextGen.
The Phase 1 safety trial will compare 2 different doses of OCU500 and is expected to enroll 80 subjects aged 18 to 64 who will be divided evenly among low dose intranasal, high dose intranasal, low dose inhaled, and high dose inhaled arms. Ocugen will provide clinical trial supplies for the NIAID-sponsored study.
Ocugen Senior VP, Commercial, Mike Shine commented, “We are grateful for our ongoing collaboration with NIAID and pleased to bring our novel vaccine technology into the clinic through Project NextGen. COVID-19 remains a real public health concern, and an increasing number of studies are showing the benefit of mucosal vaccines that attack the virus where it enters the body, through the nose and mouth, to give better and longer protection. We look forward to this important next step in potentially providing a more durable and safer option to help prevent infection and transmission of COVID-19 regarding various variants of concern.”
Chief Scientific Officer Arun Upadhyay said, “Ocugen further advanced the vector technology, enabling the incorporation of single/multiple antigens into a single vector. This innovation offers significant manufacturing flexibility in responding to emerging variants within one hundred days of identifying a circulating variant of concern. This vector technology, combined with mucosal delivery, has the potential to enable rapid development of respiratory vaccines in response to future outbreaks including bird flu.”
Read the Ocugen, Inc. press release
