New results have come out from the Phase 3 trial testing of Pfizer’s unique antiviral pill created to treat COVID-19. It was found out that its five-day oral treatment reduced COVID-related hospitalizations and deaths by 89 percent in high-risk individuals.
The pill is called Paxlovid. It is the company’s first drug designed to target SARS-CoV-2 that has completed Phase 3 human clinical trials. The antiviral is from the class of protease inhibitors drugs.
There are many protease inhibitors that have been developed to target HIV and Hepatitis C. The drugs stop the viral replication by blocking the action of a key enzyme the virus needs to multiply.
This antiviral has been under the process of developing for more than 10 years. Originally, it started getting worked upon for the first SARS virus that appeared in the early 2000s, the molecule was optimized to target SARS-CoV-2 in 2020.
The data has yet to be peer-reviewed. The trial enrolled over 2,200 subjects who claimed to be at high risk of severe COVID-19. This cohort was unvaccinated with at least one characteristic or medical condition associated with developing severe COVID-19.
It was concluded that in the beginning three days of the treatment, they were 89 percent less likely to be hospitalized or die from COVID-19 compared to those taking a placebo. A secondary group commencing the treatment within five days of symptoms appearing showed similar efficacy. There were no deaths reported unlike the 12 deaths in the placebo group.
“This news provides further corroboration that our oral antiviral candidate if authorized or approved, could have a meaningful impact on the lives of many, as the data further support the efficacy of Paxlovid in reducing hospitalization and death and show a substantial decrease in viral load,” says Pfizer CEO Albert Bourla. “This underscores the treatment candidate’s potential to save the lives of patients around the world.”
The drug is also being tested in different populations in the ongoing Phase 3 trial. The results revealed now are from the interim data from a trial testing the antiviral in a “standard risk” population. This includes vaccinated high-risk subjects and healthy adults with no specific factor making them more likely to experience severe COVID-19.
According to the interim analysis, the drug will decrease the chances of death and hospitalization by 70 percent compared to placebo. Complete data will soon be revealed in a few weeks.
Pfizer has also revealed the results of Paxlovid’s activity against the Omicron variant. The initial data states that the drug is effective against that variant too. However, more work is needed.
The US Food and Drug Administration (FDA) has not yet issued the emergency use authorization for Paxlovid. Nevertheless, Pfizer has still been supplying ongoing data from its trials. The US government has already ordered 10 million courses of antiviral treatment.