Announcing topline data from a Phase 2/3 study for Paxlovid, Pfizer (NYSE:PFE) said on Friday that the COVID-19 antiviral did not meet the main goal in the trial designed to evaluate its effect in the prevention of infection.
The recruitment of the EPIC-PEP trial, involving nearly 3,000 adults, was completed at the height of the Omicron wave. The particpants were household contacts of a symptomatic COVID patient with exposure within 96 hours. The trial participants were asymptomatic and tested negative for COVID-19 at the time of the enrollment.
After receiving the oral antiviral for five and ten days, their risk reduction in the prevention of infection stood at 32% and 37%, respectively, compared to those who received the 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 trials for the treatment and post-marketing results, the company added.
“While we are disappointed in the outcome of this particular study, these results do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness, Chief Executive Albert Bourla said.