Pardes to go public, says COVID-19 antiviral pill does not need booster (updated)

Pardes Biosciences

21/12/2021 18:59

(Adds comment from chief development officer)
    By Deena Beasley
    Dec 21 (Reuters) - Pardes Biosciences on Tuesday said early
human testing of its experimental COVID-19 antiviral pill
supports its potential as a standalone treatment and announced
plans to go public by merging with a special purpose acquisition
company.
    If the drug, PBI-0451, proves effective in later-stage
testing, it could have an advantage over similar medicines that
need to be taken with a second, booster medication, such as
Pfizer Inc's  PFE.N  two-drug antiviral regimen, Paxlovid, now
under review by the U.S. Food and Drug Administration.
 urn:newsml:reuters.com:*:nL1N2SZ1HC
    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.
    "We're hoping to be able to move as quickly as possible and
generate significant data in 2022," said Chief Development
Officer Brian Kearney.
    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.  urn:newsml:reuters.com:*:nL1N2QU17I
    "We believe the ability to have an unboosted regimen will be
important," Pardes Chief Executive Uri Lopatin told Reuters. He
said that in the United States, one in five adults are on at
least one prescription medication.
    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  FSII.O ,
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 plans to talk 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)
 ((deena.beasley@thomsonreuters.com; 213 955 6746; Reuters
Messaging: deena.beasley.thomsonreuters.com@reuters.net))