Pfizer on Monday said it has begun a middle-to-late stage clinical trial of a pill to stave off Covid in people who are exposed to infection. The aim of the trial is to assess the safety and efficacy of the drugs at preventing the infection and symptomatic disease.
What is Pfizer Pill?
The pill is an oral antiviral drug that could prevent Covid-19 infection after a person is exposed to the virus. Pfizer started developing its drug, called PF-07321332, in March 2020 and is testing it in combination with ritonavir, a repurposed HIV medicine. The pill is known as a “protease inhibitor” and has been shown in lab testing to jam up the virus’ replication machinery. If it works in real life, it will likely only be effective at the early stages of infection. By the time Covid progresses to severe disease, the virus has largely stopped replicating and patients suffer from an over-active immune response.
Clinical Trial
The pharmaceutical company has begun middle-to-late stage clinical trial of the pill to test the safety and efficacy of the pill with ritonavir, another antiviral widely used to treat HIV. The aim of the trial is to assess if the antiviral drug, PF-07321332, can prevent Covid infection in some 2,660 healthy adults living in the same house as someone with a confirmed symptomatic infection, according to a report in Forbes.
How it will Work
Patients who are part of the trial will be given PF-07321332 along with a low dose of ritonavir, an older medication widely used in combination treatments for HIV infection. One third of patients in the trial will receive a placebo and the rest of them will receive a dose of the drug twice a day for either five or 10 days. Results from an early-stage trial suggest the pill “was safe and well tolerated, the report said.
When Will it be Available?
The drug, which would could be a game changer if proven effective, may be available in the markets by the end of this year. According to a CNBC report, Pfizer began the early-stage clinical trial of the pill in March 2021 with the goal of rolling it out by year-end.
Race to Develop Oral Antivirals
Several companies are working on so-called oral antivirals, which would mimic what the drug Tamiflu does for influenza and prevent the disease from progressing to severe. “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,” said Mikael Dolsten, the company’s chief scientific officer.
A similar drug being produced by Merck & Co. and Ridgeback Biotherapeutics is called molnupiravir, and there is AT-527 being developed by Roche and Atea Pharmaceuticals.
The Research
A report published in First Post in June said that in 2020, Pfizer identified a small molecule — PF-00835231 — that blocks the SARS-CoV-2 3CLpro protease. It was originally designed against SARS-CoV-1, but the enzyme in the two viruses is almost identical. PF-00835231, both alone and in conjunction with remdesevir, appears to reduce the replication of a range of coronavirus es including SARS-CoV-2 in cells in the lab.
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