Healthcare workers are preparing doses of Pfizer-BioNTech Covid-19 vaccine at Coors Field in Denver, Colorado, on February 20th.
Photographer: Chet Strange / Bloomberg
Photographer: Chet Strange / Bloomberg
Pfizer Inc. said it has begun testing the human safety of a new coronavirus pill that could be used at the first sign of illness.
If successful in studies, the pill may be prescribed at the beginning of an infection to block viral replication before patients become very ill. The drug binds to an enzyme called a protease to prevent the virus from replicating. Protease inhibitor drugs have been successful in treating other types of viruses, including HIV and hepatitis C.
“Given how SARS-CoV-2 is moving and the continuing global impact of Covid-19, it seems likely that it will be essential to have access to therapeutic options both now and beyond the pandemic,” said Mikael Dolsten. Chief Pfizer Scientific Officer, in a statement.
In an interview, Dolsten said that no unexpected problems were seen in the study so far and that it could generate results in a few weeks.
The new protease inhibitor is the second drug Pfizer has brought to human studies to treat Covid-19. Pfizer is testing another given intravenously to hospitalized virus patients.
Pfizer shares fell 1.3% to $ 35.55 at 12:36 pm in New York. In the last year, the stock has risen by 32%.
Easy-to-use treatments are lacking for early-stage Covid-19 patients. While antibody therapies in Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. are authorized in the US for patients with Covid who have not yet been hospitalized but are at high risk of developing severe symptoms, should be infused in a hospital or doctor’s office.
This created logistical challenges that limited their use. Other therapies are intended for sick people: Gilead Sciences Inc.’s antiviral drug remdesivir it should be given as an infusion over several days and is only approved for hospitalized patients.
Among the major drug manufacturers, Merck & Co. has one of the few coronavirus pills that is far from human testing. Its experimental antiviral drug molnupiravir works through a different mechanism than the drug Pfizer and is in late human studies. Merck is developing its drug in collaboration with Ridgeback Biotherapeutics LP.
Combined process
If all goes well, Pfizer could begin a much larger 2-phase 3 study early in the second quarter, Dolsten said, potentially allowing it to apply for emergency use authorization from Food and Drug Administration by the end of this year, depending on the evolution of the pandemic.
The drug is likely to be given twice a day for about five days, he said.
“This is really a potential game changer,” Dolsten said.
While initial efficacy testing will focus on people with early infections, Pfizer also intends to explore whether the medicine works to protect healthy people who have been exposed to coronavirus, such as family members or roommates who live there. with someone who got sick.
Dolsten said the Pfizer oral protease inhibitor, codenamed PF-07321332, has 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 does not move much, which means that the therapy may work just as well against many strains, he said.
In theory, the protease inhibitor could also be combined with other antiviral drugs, such as the one Merck is developing, Dolsten said.
Pfizer said it intends to share more data about the compound at its April 6 American Chemical Society meeting.
(Updates to Merck Partner Name in paragraph 9)