Exclusive-Pardes to go public, saying that antiretroviral COVID-19 doesn’t need booster

PBI-0451 in pill form
The protease inhibitor PBI-0451 for the treatment of coronavirus disease (COVID-19) is seen in a container in this undated handout photo obtained by Reuters on December 16, 2021. Pardes Biosciences / Handout via REUTERS

December 21, 2021

By Deena Beasley

(Reuters) – Pardes Biosciences on Tuesday said initial human trials show its experimental COVID-19 antiviral drug works as a standalone treatment and announced plans to launch a public them by merging with a special-purpose acquiring company.

If the drug, called PBI-0451, proves effective in a later-stage trial, it could have an advantage over similar drugs that need to be taken with a second booster, such as Antiviral drug Pfizer Inc, Paxlovid, is currently under review by the US Food and Drug Administration.

Pardes said it hopes to complete the current Phase I study in healthy volunteers early next year. It aims to start 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 in fighting disease because they can be taken at home early after symptoms appear to prevent people from going to the hospital.

Pardes is a protease inhibitor, designed to stop the coronavirus from replicating in human cells. It’s the same class of drugs as Pfizer’s nirmatrelvir, which, in combination with the older antiviral ritonavir, has been shown to reduce the risk of hospitalization or death for high-risk COVID-19 patients by 89%. heavy.

Ritonavir is used to prolong the effects of Pfizer tablets, but it can also affect certain other medicines the patient may be taking, increasing the risk of complications.

“We believe the ability to have a non-adherent regimen will be important,” Pardes CEO Uri Lopatin told Reuters. He said that in the United States, one in five adults uses at least one prescription drug.

Pfizer, which says the drug-drug interaction problem is manageable, is awaiting FDA emergency authorization for Paxlovid.

“If you look at hepatitis C and HIV as proxies for COVID, you see first generation compounds,” said Jim Tananbaum, founder and CEO of healthcare investment firm Foresite Capital. appear and then over time you will see better and better options.” .

Some of the newer hepatitis C drugs are considered progressive in part because they are highly effective without ritonavir.

Foresite is a sponsor of FS Development Corp II, a so-called white check company established to raise cash for acquisitions as an alternative to an initial public offering of shares. traditional. A shareholder vote on the consolidation of Pardes and FS II is scheduled for Thursday.

Company officials said Pardes is in talks with regulators about designing a larger global trial of PBI-0451, including number of participants and geographic location.

(Reporting by Deena Beasley; Editing by Bill Berkrot) Exclusive-Pardes to go public, saying that antiretroviral COVID-19 doesn’t need booster

Bobby Allyn

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