EPIC-PEP study will enrol up to 2,660 healthy participants, aged 18 years and above, who live together with someone confirmed with Covid-19
Pfizer begins study of PF-07321332 for Covid-19. (Credit: Coolcaesar/Wikipedia.)
Pfizer has initiated a Phase 2/3 EPIC-PEP study to evaluate its potential novel oral antiviral candidate PF-07321332 to prevent Covid-19 infection.
PF-07321332 is an oral antiviral SARS-CoV-2-3CL protease inhibitor, with a promising pre-clinical profile, and potential in-vitro antiviral activity against coronaviruses.
In the study, PF-07321332 will be co-administered with a low dose of HIV treatment ritonavir.
EPIC-PEP (Evaluation of Protease Inhibition for Covid-19 in Post-Exposure Prophylaxis) is a randomised, double-blind, placebo-controlled study.
It is a part of the global EPIC programme, which includes an ongoing study in high-risk SARS-CoV-2 infected patients, and another in infected patients who are at standard risk.
The study is designed to enrol up to 2,660 healthy participants aged 18 years and above, who live together with an individual with confirmed symptomatic SARS-CoV-2 infection.
Evaluating safety and efficacy for the prevention of confirmed SARS-CoV-2 infection and its symptoms through 14 days include the primary objective of the study.
Pfizer worldwide research, development and medical president and chief scientific officer Mikael Dolsten said: “With the continued impact of Covid-19 around the world, we believe that tackling the virus will require effective treatments for people who contract, or have been exposed to the virus.
“If successful, we believe this therapy could help stop the virus early – before it has had a chance to replicate extensively – potentially preventing symptomatic disease in those who have been exposed and inhibiting the onset of infection in others.
“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.”
In a separate development, Pfizer has dosed the first participants in Phase 1 clinical trial of a single dose quadrivalent mRNA vaccine against influenza in healthy adults.
The Phase 1 study will evaluate the safety, tolerability, and immunogenicity of the influenza vaccine in healthy adults aged 65-85 years, in the US.
Pfizer said that the study is part of its mRNA influenza vaccine programme, and leverages its mRNA technology for influenza.
Furthermore, the company intends to explore mRNA in other respiratory viruses beyond influenza, and expand the mRNA technology in oncology, and genetic diseases.
Pfizer senior vice president and vaccine research and development head Kathrin U Jansen said: “Since 2018, we have been working to develop a potential mRNA influenza vaccine, driven by our deep understanding of infectious diseases and our extensive experience in researching, developing and implementing new vaccine technologies to help prevent them.
“The Covid-19 pandemic allowed us to deliver on the immense scientific opportunity of mRNA. Influenza remains an area where we see a need for vaccines which could result in improved efficacy in any given season, and we believe mRNA is the ideal technology to take on this challenge to transform global health outcomes.”