LONDON: The first human trials of a single pill cure for
Covid-19 are underway which, if successful, would mean Covid-19 could be treated by patients at home without needing to be hospitalised.
Phase 1 trials of a pill developed by
Pfizer are taking place in the US and
Belgium among approximately 60 healthy volunteers aged between 18 and 60. The antiviral drug, classed as a protease inhibitor, has been tested on animals without any significant safety risks.
"This Phase 1 trial is being conducted in the US. The oral antiviral clinical candidate PF-07321332, a SARS-CoV2-3CL protease inhibitor, has demonstrated potent in vitro anti-viral activity against
SARS-CoV-2, as well as activity against other coronaviruses, suggesting potential for use in the treatment of Covid-19 as well as potential use to address future coronavirus threats," Pfizer said in a statement. "This is the first orally administered coronavirus-specific protease inhibitor to be evaluated in clinical studies."
Protease inhibitors bind to a viral enzyme (called a protease), preventing the virus from replicating in the cell. Protease inhibitors have been effective at treating other viral pathogens such as HIV and the Hepatitis C virus, both alone and in combination with other antivirals.
The Phase I trial is a randomised, double-blind, sponsor-open, placebo-controlled, single- and multiple-dose escalation study in healthy adults evaluating the safety, tolerability and pharmacokinetics of the drug. If successful, phase 2 and 3 trials among a larger number of people will take place.
Mikael Dolsten, Pfizer chief scientific officer and president (worldwide research, development and medical), said: "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 hospitalised or in critical care."
"Given the programme is still in research and development, we cannot speculate on any potential, timeline or outcome," a Pfizer spokesperson said.
Pfizer is also investigating an intravenously administered investigational protease inhibitor, PF-07304814, currently in a Phase 1-b multi-dose trial among hospitalised clinical trial participants with Covid-19.
Albert Bourla, CEO and chairman of Pfizer, told
CNBC this week: "In India it is a horrible situation. In a pandemic you are only as protected as your neighbour. If we cannot provide solutions for India and
Africa they will become the pool where the virus will replicate and generate variants."