Pfizer Inc has started early-stage human trials of a new oral drug that could be administered to patients as soon as they show symptoms of COVID-19 infection.
Pfizer started trials for COVID-19 pill
According to the drugmaker, the antiviral candidate manifested 'potent' efficacy against the coronavirus in lab trials, which developed the first approved COVID-19 vaccine in the US with Germany's BioNTech SE. Pfizer's candidate, known as PF-07321332, which belongs to the protease inhibitor family of drugs. The COVID-19 pill will prevent the virus from replicating itself within human cells by inhibiting an enzyme used by the virus, as per Daily Mail.
According to the firm, protease inhibitors have been useful in treating other viral infections such as HIV and hepatitis C virus, both individually and in combination with other antivirals. Since currently marketed therapeutics that function along the same lines has not identified any safety issues, Pfizer claims this class of molecules could provide well-tolerated treatments against COVID-19.
In a statement, Pfizer's chief scientific officer, Mikael Dolsten, said, "Tackling the COVID-19 pandemic involves both prevention through vaccination and targeted medication for those who contract the virus." He added that given how SARS-CoV-2 is mutating and COVID-19's global effects, it appears possible that access to therapeutic solutions will be crucial both now and after the pandemic.
The Phase I trial is a randomized, double-blind study in which certain volunteers will receive the COVID-19 pill and others will receive a placebo, with neither the researchers nor the volunteers know which pill they will take. The company will go on to Phase II and recruit many patients if the findings indicate the drug is safe and successful.
It's still unknown how long the drug would last or how many days people would take the pill every day or week. In an early-stage experiment in hospitalized COVID-19 patients, the firm also tests an intravenously administered antiviral candidate.
Pfizer's candidate is in the same state of development as two other oral antiviral drugs in mid-stage trials: one from Merck & Co and Ridgeback Bio, and the other from Roche Holding and Atea Pharmaceuticals. Remdesivir, a drug developed by Gilead Sciences, is officially approved by the US Food and Drug Administration (FDA) for COVID-19 treatment.
However, the FDA has approved two combination drugs, one from Eli Lilly and the other from Regeneron, for emergency use. Pfizer plans to use the mRNA technologies that contributed to its COVID-19 shot to develop new vaccines, says the company's statement regarding the pill.
Pfizer Chief Executive Officer Albert Bourla told The Wall Street Journal, "There is a technology that has shown significant impact and dramatic potential. Because of our size and experience, we are the most positioned firm right now to move it to the next level."
Pfizer uses the same technology common in treating HIV
Pfizer, the manufacturer of the most commonly used COVID-19 vaccine in the United States, is researching a new COVID-19 pill-based treatment using the same class of drug used to treat HIV, Newsweek reported. In test-tube tests, the drug showed efficacy against the virus that causes COVID-19, as well as other forms of coronaviruses, increasing the likelihood of "potential use to counter possible coronavirus risks," according to the company.
Dolsten praised both the oral drug and the company's recently developed experimental protease inhibitor therapy, which is now in phase 1b trials and is expected to be given intravenously to hospitalized COVID-19 patients. Two separate methods, Dolsten said, have the ability to develop an end-to-end treatment paradigm that enhances vaccination in situations where disease persists.
Although none of the vaccines have 100% defense against the virus, they have been shown to decrease infections and avoid hospitalizations and death. While both Pfizer and Moderna are researching booster shots or alternative versions of vaccines to tackle emerging strains, treatment alternatives could help reduce questions raised by the fact that some of the mutations now circulating the world have demonstrated a small degree of resistance to the vaccines.