Ocugen (OCGN) - Get Report shares spiked Wednesday after the eye-drug developer said its partner from India, Bharat Biotech, reported that in an interim analysis of a clinical trial, their coronavirus-vaccine candidate provided strong protection against COVID-19.
The ongoing Phase 3 study of their vaccine candidate, Covaxin, demonstrated a vaccine efficacy of 81%, Ocugen said.
Shares of Ocugen at last check jumped 35% to $13.01.
"These results, which in part suggest significant immunogenicity against the rapidly emerging UK variant, represent an additional step towards outlining the regulatory pathway for [emergency use authorization] and approval in the U.S.," Shankar Musunuri, co-founder, chairman and chief executive of Ocugen, said in a statement.
In December, Hyderabad-based vaccine producer Bharat Biotech unveiled a partnership with Ocugen, Malvern, Pa., to develop Covaxin for the U.S. market.
“Today’s results from the interim analysis of Bharat Biotech’s Phase 3 trial of Covaxin mark a milestone in the development of another critical vaccine option for the U.S. market," Bruce Forrest, a physician who sits on the vaccine scientific advisory board of Ocugen, said.
Covaxin is one of the two Covid-19 vaccines approved for emergency use in India, even though efficacy data from its late-stage trial was awaited.
Bharat Biotech Chairman Krishna Ella said Covaxin has also shown “significant immunogenicity” against emerging variants, Bloomberg reported.
The Phase 3 trial that enrolled 25,800 participants aged 18 to 98 “was a challenging task for us,” Ella said.
The interim analysis was based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group against seven cases seen in a set injected with Covaxin.