Pfizer Inc (NYSE: PFE) has initiated a Phase 2/3 EPIC-PEDS trial to evaluate Paxlovid (nirmatrelvir and ritonavir tablets) in COVID-19 pediatric patients.
The trial will include non-hospitalized, symptomatic pediatric participants with a confirmed diagnosis of COVID-19 who are at risk of progression to severe disease. The Phase 2/3 trial has approximately 140 pediatric participants under 18 years of age.
Initial enrollment features two cohorts; Cohort 1 includes participants weighing at least 40 kg, and Cohort 2 consists of patients weighing 20 kg - 40 kg.
Related: Pfizer Commits 10M Courses Of COVID-19 Oral Antiviral To Developing Countries: Reuters.
Participants enrolled in Cohort 1 will receive Paxlovid (nirmatrelvir/ritonavir 300 mg/100 mg) orally twice daily for five days, the currently authorized dosing for pediatric patients 12 years of age and older weighing at least 40kg. Participants enrolled in Cohort 2 will receive Paxlovid (nirmatrelvir/ritonavir 150 mg/100 mg) orally twice daily for five days.
Pfizer is also developing an age-appropriate formulation for three additional planned cohorts with patients younger than six years old.
The Company will start enrollment as data from Cohorts 1 and 2, and the new formulation is available.
Price Action: PFE shares are up 2.92% at $48.83 during the market session on the last check Wednesday.
