Pfizer’s experimental oral COVID-19 antiviral therapeutic could be ready by the end of the year, the company’s chief executive officer (CEO) Albert Bourla (pictured above) told CNBC on Tuesday.
If all goes well in clinical studies for the drug, it could be available for the treatment of patients in the US by the end of 2021, according to Bourla.
The oral antiviral clinical candidate – known as PF-07321332 – is a SARS-CoV-2-3CL protease inhibitor, designed to bind to a viral enzyme and thereby prevent the virus from replicating in the cell.
The drug has already demonstrated potent in vivo anti-viral activity against SARS-CoV-2, according to Pfizer, as well as activity against other coronaviruses.
Previously, protease inhibitors have been shown to be effective for the treatment of other viral pathogens, including HIV and hepatitis C virus when used alone or in combination with other antivirals.
The phase 1 trial has completed the dosing of single ascending doses of the drug in healthy adults and has since progressed to testing multiple ascending doses.
Pfizer is also investigating an intravenously administered investigational protease inhibitor – PF-07304814 – which is currently in a phase 1b multi-dose trial in hospitalised participants with COVID-19.
“We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalised or in critical care,” said Mikael Dolsten, chief scientific officer and president, worldwide research, development and medical of Pfizer.
“At the same time, Pfizer’s intravenous antiviral candidate is a potential novel treatment option for hospitalised patients. Together, the two have the potential to create an end-to-end treatment paradigm that complements vaccination in cases where disease still occurs,” he added.
Pfizer has found massive success with its BioNTech-partnered COVID-19 vaccine, with the company recently announcing positive topline results for the jab in adolescents.
The vaccine – BNT162b2 – demonstrated 100% efficacy and ‘robust antibody responses’ in participants aged 12 to 15, Pfizer announced in March.
Bourla also told CNBC that he is “very optimistic” that the US Food and Drug Administration (FDA) will approve the vaccine in this age group.
Pfizer has also launched a clinical study to evaluate BNT162b2 in children of six months to 11 years of age, in a bid to extend the use of the vaccine into a wide paediatric population.