The initiative marks a milestone in the biopharmaceutical industry’s COVID-19 response efforts as it now seeks to protect not just those who had contracted the virus but also those who are around them.
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Pfizer is ready for a Phase II/III trial for an oral COVID-19 vaccine candidate that aims to prevent severe illness in people living with somebody diagnosed with a SARS-CoV-2 infection.
The initiative marks a milestone in the biopharmaceutical industry’s COVID-19 response efforts as it now seeks to protect not just those who had contracted the virus but also those who are around them. As of this writing, there is no orally administered therapy that’s approved as a post-exposure or pre-emptive treatment of COVID-19.
The global Phase II/III study called the EPIC -PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) trial, investigates the effectiveness of combining Pfizer’s oral antiviral candidate PF-07321332 with a low dose of ritonavir to prevent infection.
PF-07321332, a protease inhibitor, has shown a positive pre-clinical profile, including potent activity against SARS-CoV-2 in vitro.
During the Phase I trial conducted in March 2021, participants were given the drug at the first sign of infection or awareness of an exposure. It was co-administered with a low dose of ritonavir because the latter is known to help slow down the metabolism of PF-07321332, enough for it to remain active in the body to fight the virus. Phase I trial conducted in March 2021 showed PF-07321332 to be well-tolerated and safe.
“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, complementing the impact that vaccines have had in helping quell infections. 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,” said Mikael Dolsten, M.D., Ph.D., the chief scientific officer and president for Worldwide Research, Development, and Medical at Pfizer, in a statement.
The Phase II/III trial will cover up to 2,660 healthy individuals aged 18 years and up and living in the same household as a confirmed symptomatic patient. In the randomized, double-blind placebo-controlled trial, participants will be randomly given PF-07321332 plus ritonavir or a placebo two times a day for five to 10 days. The main objective is to assess the efficacy and safety of the combination in preventing SARS-CoV-2 infection and its symptoms up to Day 14.
The global EPIC program goes beyond this trial and is composed of several studies, all targeting to find preventive and therapeutic solutions against the virus.
In July this year, Pfizer started a related study on SARS-CoV-2 infected patients who are at high risk of hospitalization or death (EPIC-HR), while just last month, it launched another trial (EPIC-SR) for infected patients who are at standard risk or no risk factors for severe illness. Both trials are evaluating the efficacy and safety of PF-07321332 plus ritonavir.
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