Pfizer begins phase 1 study of Covid drug candidate PF-07321332
Pfizer said that it has initiated a phase 1 study in the US for assessing the oral antiviral therapeutic PF-07321332 against SARS-CoV-2, the virus that causes Covid-19.
The US pharma giant said that it has completed the dosing of single ascending doses in the participating healthy adults in the early-stage clinical trial. Pfizer will now progress to multiple ascending doses.
The randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study of PF-07321332 will assess the safety, tolerability, and pharmacokinetics of the oral antiviral therapeutic for SARS-CoV-2.
PF-07321332, which is a SARS-CoV2-3CL protease inhibitor, has shown potential in vitro anti-viral activity against SARS-CoV-2. Besides, it has shown activity against other coronaviruses, which indicate its potential for use in the treatment of Covid-19 and also possible use for addressing future coronavirus threats.
Mikael Dolsten – Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer said: “Tackling the COVID-19 pandemic requires both prevention via vaccine and targeted treatment for those who contract the virus. Given the way that SARS-CoV-2 is mutating and the continued global impact of COVID-19, it appears likely that it will be critical to have access to therapeutic options both now and beyond the pandemic.
“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. At the same time, Pfizer’s intravenous antiviral candidate is a potential novel treatment option for hospitalized patients.
“Together, the two have the potential to create an end to end treatment paradigm that complements vaccination in cases where disease still occurs.”
Pfizer is also evaluating PF-07304814, an intravenously administered investigational protease inhibitor, which is presently in a phase 1b multi-dose trial in patients hospitalized with Covid-19.