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Pfizer Launches Global Phase 2/3 EPIC-PEP Study of a New COVID-19 Oral Antiviral Drug for Post-Exposure Prophylaxis in Adults. the official website of a pharmaceutical company.

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EPIC-PEP (Evaluation of COVID-19 Protease Inhibition in Post-Exposure Prophylaxis) is the third study launched as part of this global clinical research program.

The new study will evaluate a new protease inhibitor (PF-07321332, given at the same time as low-dose ritonavir) for disease prevention in adults living in the same household as someone with COVID-19.

PF-07321332 has been specifically designed for oral administration, so it can potentially be administered at the first sign of infection or exposure to SARS-CoV-2, without the need to hospitalize patients.

Pfizer Inc. today announced the start of a Phase 2/3 EPIC-PEP (Evaluation of COVID-19 Protease Inhibition in Post-Exposure Prophylaxis) study to evaluate the investigational new oral antiviral candidate PF-07321332 co-administered with low dose ritonavir to prevent COVID-19 infection. This Phase 2/3 trial is part of a global clinical research program and includes individuals at least 18 years of age living in the same home as someone with confirmed symptomatic SARS-CoV-2 infection.

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“Given the ongoing impact of COVID-19 around the world, we believe that combating the virus will require effective treatments for people who become infected or exposed to the virus, complementing the impact that vaccines have had in suppressing infections. If successful, we believe this therapy could help stop the virus early—before it has a chance to replicate widely—potentially preventing symptomatic disease in those exposed and suppressing the onset of infection in others." said Mikael Dolsten, MD, PhD, Chief Scientific Officer and President of Global Research, Development and Medicine, Pfizer. “Given the continued emergence and evolution of SARS-CoV-2 variants and their enormous impact, we continue to work diligently to develop and study new ways in which our investigational oral antiviral candidate can potentially reduce the impact of COVID-19 not only on the patient, but also on his neighbors and family members.

The Phase 2/3 EPIC-PEP study is a randomized, double-blind, placebo-controlled trial that will enroll up to 2660 healthy adults aged 18 years and older. Participants will be randomly assigned (1:1:1) to receive PF-07321332/ritonavir or placebo orally twice daily for 5 or 10 days. The primary objective is to evaluate the safety and effectiveness of preventing confirmed SARS-CoV-2 infection and its symptoms up to day 14. PF-07321332 is an oral antiviral inhibitor of the SARS-CoV-2-3CL protease with promising preclinical results. Results from a phase 1 clinical trial showed that PF-07321332 is safe and well tolerated.

In addition to this study, the global EPIC program consists of several ongoing clinical trials, including one involving patients infected with SARS-CoV-2 who are at high risk of severe illness (including hospitalization or death), which began in July 2021. and with the presence of other infected patients who are at standard risk (i.e., do not have risk factors for severe illness), which began in August 2021.

PF-07321332 is an investigational SARS-CoV-2-3CL protease inhibitor antiviral therapy specifically designed for oral administration so that it can be prescribed at the first sign of infection or at first awareness of exposure without requiring hospitalization of patients. Protease inhibitors such as PF-07321332 are designed to block the activity of the main protease enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir is expected to help slow the metabolism or breakdown of PF-07321332 so that it remains active in the body for longer periods of time at higher concentrations to help fight the virus.

In March 2021, Pfizer introduced PF-07321332 in a Phase 1 study in healthy adults to evaluate the safety, tolerability and pharmacokinetics of the study compound. In July, he transitioned to a Phase 2/3 study, EPIC-HR (Evaluation of COVID-19 Protease Inhibition in High-Risk Patients), to evaluate the efficacy and safety in combination with ritonavir in participants with a confirmed diagnosis of SARS-CoV-2 infection with high risk of progression to severe illness.

In August, Pfizer began a Phase 2/3 study, EPIC-SR (Evaluation of COVID-19 Protease Inhibition in Patients at Standard Risk), to assess efficacy and safety in participants with a confirmed diagnosis of SARS-CoV-2 infection who are at standard risk. (i.e., do not have risk factors for severe illness).

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PF-07321332 is the first investigational oral coronavirus-specific protease inhibitor to be evaluated in clinical trials.

There is currently no approved oral therapy for post-exposure or preventive treatment for COVID-19.

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