Saturday, June 22, 2024

Pfizer begins mid-to-late-stage study for Covid-19 antiviral drug

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Pfizer Inc today announced the start of a mid-to-late-stage study testing its investigational oral antiviral drug, to be co-administered with HIV drug ritonavir, for the prevention of Covid-19 infection.

“This Phase 2/3 trial is part of a global clinical research program and is enrolling individuals who are at least 18 years old and live in the same household as an individual with a confirmed symptomatic SARS-CoV-2 infection,” Pfizer said in a statement.

Pfizer said 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,”

“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,” said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer.

“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,” he added

The Phase 2/3 trial of the drug is a randomised, double-blind, placebo-controlled study and will enroll up to 2,660 healthy adult participants aged 18 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 will assess safety and efficacy for the prevention of confirmed SARS-CoV-2 infection and its symptoms through Day 14.

PF-07321332 is an oral antiviral SARS-CoV-2-3CL protease inhibitor, which has an encouraging pre-clinical profile, including potent in vitro antiviral SARS-CoV-2 and broad coronavirus activity.

Results from the Phase 1 clinical trial demonstrated that PF-07321332 was safe and well tolerated, according to the company

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