Thursday, October 28, 2021
Ocugen (OCGN)
Ocugen Files IND For Phase 3 Covaxin Trial
Ocugen Inc is a clinical stage biopharmaceutical company. It is focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Ocugen offers a diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases.
Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.
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IND Submitted To Begin Unvaccinated Patient and Booster Study Ocugen has submitted an IND to begin a Phase 3 study testing Covaxin (BBV152) as a vaccine for COVID-19. The study will enroll unvaccinated patients and those vaccinated at least six months prior to determine if immune responses in US patients are comparable with those seen in the Phase 3 conducted in India. If successful, we expect the data to be submitted for marketing approval.
Study Design Patients will be randomized to receive two doses of either Covaxin or placebo 28 days apart. The primary endpoint will compare blood-based samples taken from the US study with samples from patients in the Phase 3 Bharat biotech trial. The secondary endpoints test the vaccine’s immunogenic profile, safety, and tolerability. The company hopes to complete the study during …
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