Health professionals prepare doses of the Pfizer-BioNTech Covid-19 vaccine at Coors Field in Denver, Colorado, Feb. 20.
Photographer: Chet Strange / Bloomberg
Photographer: Chet Strange / Bloomberg
Pfizer Inc. said it has begun human safety testing of a new coronavirus treatment pill that can be used at the first sign of illness.
If it succeeds in trials, the pill can be prescribed early in an infection to block viral replication before patients become very ill. The drug binds to an enzyme called a protease to keep the virus from multiplying. Protease inhibiting drugs have proven successful in treating other types of viruses, including HIV and hepatitis C.
“Given how SARS-CoV-2 mutates and the ongoing global impact of Covid-19, it seems likely that access to therapeutic options will be critical both now and after the pandemic,” said Mikael Dolsten , Pfizer’s Chief Science Officer, in a statement.
In an interview, Dolsten said that no unexpected problems had been seen in the study so far and that it could yield results within weeks.
The new protease inhibitor is the second drug that Pfizer has put in human trials to treat Covid-19. Pfizer is testing another one that is administered intravenously to hospitalized virus patients.
Pfizer shares fell 1.3% to $ 35.55 at 12:36 p.m. New York. The stock has risen by 32% in the past year.
Easy-to-use treatments are lacking for early-stage Covid-19 patients. While antibody therapies from Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. is approved in the US for Covid patients who are not yet hospitalized but are at high risk of developing serious symptoms. They must be administered in the hospital or by a doctor.
That has created logistical challenges that have limited its use. Other therapies are for sick people: Gilead Sciences Inc.’s antiviral drug remdesivir. must be administered over several days and is only approved for hospital patients.
Among the major drug manufacturers, Merck & Co. has one of the few coronavirus pills that is well in the human tests. The experimental antiviral drug molnupiravir works by a different mechanism than the Pfizer drug and is at a late stage in human trials. Merck is developing its drug in collaboration with Ridgeback Biotherapeutics LP.
Combined trial
If all continues to go well, Pfizer could begin a much larger combined phase 2-phase 3 trial early in the second quarter, Dolsten said, potentially allowing it to apply for an emergency use permit from the Food and Beverage industry by the end of this quarter. Drug Administration. years, depending on how the pandemic evolves.
The drug will likely be given twice a day for about five days, he said.
“This is really a potential game changer,” said Dolsten.
While initial efficacy tests will focus on people with early infections, Pfizer also plans to investigate whether the drug works to protect healthy people exposed to the coronavirus, such as family members or roommates living with someone who has become ill.
Dolsten said Pfizer’s oral protease inhibitor, code-named PF-07321332, had a number of potential benefits. In laboratory tests, it worked against many coronaviruses, including the original SARS virus and MERS. In addition, the coronavirus protease doesn’t mutate much, meaning the therapy will likely work equally well against numerous variant strains, he said.
In theory, the protease inhibitor could also be combined with other antivirals, such as the one Merck is developing, Dolsten said.
Pfizer said it plans to share more data on the substance at the American Chemical Society meeting April 6.
Updates with Merck partner name in 9th paragraph