Pfizer (NYSE:PFE) has announced the launch of the Phase 2/3 EPIC-PEP study to test its oral antiviral candidate PF-07321332 as a post-exposure prophylaxis.
The EPIC-PEP study, whose name is an acronym of “Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis,” will test the efficacy of PF-07321332 with low-dose ritonavir to prevent COVID-19 infection.
PF-07321332 and ritonavir are both protease inhibitors. AbbVie’s Ritonavir (Norvir) initially won FDA approval as an HIV treatment in 1996.
Molecular structure of PF-07321332. Image from Wikipedia.
Trial participants must be 18 or older and live in the same household as an individual with laboratory-confirmed symptomatic SARS-CoV-2 infection.
The study will enroll up to 2,660 participants.
“Given the continued emergence and evolution of SARS-CoV-2 variants and their immense impact, we continue to work diligently to develop and study new ways that our investigational oral antiviral candidate could potentially lower the impact of COVID-19, not only on patients’ lives but also the lives of their families and household members,” said Dr. Mikael Dolsten, chief scientific officer and president, worldwide R&D and Medical at Pfizer.
Other companies, including Merck & Co. and smaller players such as Pardes Biosciences, are also developing COVID-19 antivirals.
Pfizer has several clinical trials under the EPIC umbrella, including those testing the drug’s efficacy in patients with a high risk of developing severe COVID-19.