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 If the drug, called PBI-0451, proves effective in later-stage
testing, it could have an advantage over similar pills that need to
be taken with a second, booster medication, such as the Pfizer Inc
two-drug antiviral regimen, Paxlovid, now under consideration by the
U.S. Food and Drug Administration.
Pardes said it expects to complete its current Phase I study in
healthy volunteers early next year. It aims to begin by mid-year a
larger trial that could be used to seek regulatory approval for the
COVID-19 antiviral pill.
There are currently no authorized oral COVID-19 treatments. But they
are expected to become important tools against the illness because
they can be taken at home early after symptoms appear to keep people
out of the hospital.
The Pardes drug is a protease inhibitor, designed to prevent the
coronavirus from replicating in human cells. That is the same class
of medicine as Pfizer's nirmatrelvir, which in combination with the
older antiviral ritonavir was shown to cut the risk of
hospitalization or death by 89% for COVID-19 patients at high risk
of severe illness.
Ritonavir is used to extend the action of the Pfizer pill, but can
also interfere with some other medicines a patient may be taking,
raising the risk of complications.
"We believe the ability to have an unboosted regimen will be
important," Pardes Chief Executive Officer Uri Lopatin told Reuters.
He said that in the United States, one in five adults are on at
least one prescription medication.
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 Pfizer, which says the issue of
drug-drug interactions is manageable, is
awaiting emergency authorization from the FDA
for Paxlovid.
"If you look at hepatitis C and HIV as proxies
for COVID, you'll see first generation compounds
come out and then over time you'll see better
and better options," said Jim Tananbaum, founder
and CEO of healthcare investment firm Foresite
Capital. Some newer hepatitis C
drugs were considered to be advances in part because they were
highly effective without the need for ritonavir.
Foresite is the sponsor of FS Development Corp II, a so-called blank
check company set up to raise cash for acquisitions as an
alternative to a traditional initial public offering. A shareholder
vote on the merger of Pardes and FS II is scheduled for Thursday.
Company officials said Pardes is in talks with regulators about the
design of a larger, global trial of PBI-0451, including the number
of participants and geographic locations.
(Reporting By Deena Beasley; Editing by Bill Berkrot)
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