Ocugen (OCGN) – Phase 2/3 Immuno-Bridging Study Meets Co-Endpoints

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Tuesday, January 17, 2023

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product, Covaxin, is a killed-virus vaccine for COVID-19 in-licensed from Bharat Biotech (India). The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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Bridging Study Shows Equivalence. Ocugen announced that its Phase 2/3 immuno-bridging study for Covaxin met both its co-primary immunogenicity endpoints.  The study was designed to demonstrate that vaccination with Covaxin in US patients stimulated immunogenicity that is equivalent to the Phase 3 study conducted by Bharat Biotech in India in 2020.  The study also assessed the boosting effect of Covaxin in patients previously receiving an mRNA or viral vector vaccine.

Study Design.  The OCU-002 immuno-bridging study was a randomized, placebo-controlled study that enrolled 419 patients at 8 clinical sites. This was intended to test Covaxin in a demographically diverse population of healthy adults in the US with current SARS-CoV-2 strains. Participants received a first dose of Covaxin or placebo followed by a second dose 28 days later. The immune response was evaluated using microneutralization test (MNT) assay by a blinded observer.

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