Ocugen ( NASDAQ: OCGN ) added ~15% pre-market, announcing that a U.S. trial for the COVID-19 vaccine candidate the company develops with India’s Bharat Biotech reached both co-primary endpoints in a Phase 2/3 clinical trial.
The randomized study involving 419 U.S. adults was designed to evaluate the effect of two doses of COVAXIN or placebo given 28 days apart.
According to the topline data, COVAXIN reached the co-primary immunogenicity endpoints in the study, exceeding the non-inferiority limits for antibody generation and seroconversion rates.
In terms of safety, there were no vaccine-related serious adverse events, thrombotic events, or cases of myocarditis or pericarditis.
The company noted that COVAXIN, an inactivated form of COVID-19 vaccine, offers a broader immune response compared to currently approved COVID shots in the U.S.
Ocugen ( OCGN ) added that topline data from this immuno-bridging and broadening study would support the company’s plans for COVAXIN in the U.S.
Read: Seeking Alpha contributor Keith Williams questions if Ocugen ( OCGN ), which also develops a mucosal COVID vaccine, can compete with the likes of Pfizer ( PFE ) and Moderna ( MRNA ), the leaders in mRNA vaccine technology.
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Ocugen gains ~15% as U.S.-based trial for COVID vaccine meets main goals