Pfizer Starts Phase 1 Trial of Oral Pill to Treat COVID-19

Pfizer Inc has started early stage study of a new oral antiviral drug for SARS-CoV-2, the virus that causes COVID-19.

New oral antiviral drug candidate named "PF-07321332", inhibits proteases in SARS-CoV2 virus and it has demonstrated potent in vitro anti-viral activity, as per the US pharmaceutical company Pfizer.

The drug candidate has potential use to address future coronavirus threats.

‘New oral antiviral candidate PF-07321332 has a potential for use in the treatment of COVID-19.’
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"We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalized or in critical care," said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer.

"At the same time, Pfizer's intravenous anti-viral candidate is a potential novel treatment option for hospitalised patients. Together, the two have the potential to create an end-to-end treatment paradigm that complements vaccination in cases where the disease still occurs," Dolsten added.

Protease inhibitors act by preventing the virus from replicating in the cell. They have been effective at treating other viral pathogens such as HIV and hepatitis C virus, both alone and in combination with other anti-virals, the company said.

Coronavirus
Coronaviruses infect animals, humans, and birds. Human coronaviruses, such as SARS, MERS, and 2019-nCoV cause respiratory distress and even death. The S protein is the infectious agent of the virus.

This Phase 1 trial is a randomized, double-blind, sponsor-open, placebo-controlled, single and multiple dose-escalation study in healthy adults evaluating the safety, tolerability and pharmacokinetics of PF-07321332.

Previously preclinical studies have demonstrated the antiviral activity of this potential first-in-class SARS-CoV-2 therapeutic designed specifically to inhibit replication of the SARS-CoV2 virus.

The company is loos forward in investigating an intravenously administered investigational protease inhibitor, PF-07304814, which is currently in Phase 1b multi-dose trial in hospitalized clinical trial participants with COVID-19.

Together, the two (oral and intravenous candidates) have the potential to create an end-to-end treatment paradigm that complements vaccination in cases where disease still occurs," Pfizer's Chief Medical Officer Mikael Dolsten said in a statement.

Source-Medindia