Announcement of top-line data from a Phase 2/3 study for Paxlovid, Pfizer (NYSE: PFE) said on Friday that COVID-19 antiviral did not meet the main objective of the trial designed to evaluate its effect in preventing infection.
The recruitment of the EPIC-PEP trial, which involved nearly 3,000 adults, was completed at the height of the Omicron wave. Participants were household contacts of a symptomatic COVID patient with exposure within 96 hours. Trial participants were asymptomatic and tested negative for COVID-19 at the time of enrollment.
After receiving the oral antiviral agent for five and ten days, their risk reduction in infection prevention was 32% and 37%, respectively, compared with those receiving placebo.
Therefore, the trial did not meet the primary endpoint of reducing the risk of symptomatic COVID-19 infection with statistical significance, Pfizer (PFE) said.
The safety data were mostly consistent across other studies for treatment and post-marketing results, the company added.
“While we are disappointed with the outcome of this particular study, these findings do not affect the strong efficacy and safety data we have observed in our previous trials in the treatment of COVID-19 patients at high risk of developing serious disease,” said the CEO. said Albert Bourla.
Last December, the United States approved Paxlovid for home use in high-risk COVID-19 patients, and Pfizer (PFE) aims to generate $ 22 billion in drug revenue by 2022.