TOI: Dozens of volunteers have begun participation in initial trials for a pill that pharmaceutical company Pfizer hopes will be a cure for COVID-19 available later this year, the Daily Telegraph reported Saturday.
The trial is being held at two Pfizer locations, one in the US and the other in Belgium, and will involve up to 60 volunteers age 18-60.
The trial will be split into three phases spread over 145 days, with an extra 28 days tacked on the end for “screening and dosing,” according to the report, and will include several overnight stays for the participants.
“If they have moved to this stage, they will be quietly optimistic,” Prof. Penny Ward, a visiting professor in pharmaceutical medicine at King’s College London, told the Telegraph.
“The question will be about how the drug is tolerated,” said Ward, who helped develop Tamil, an antiviral treatment against flu.
The first phase will look at how well the new drug is tolerated and if there are “significant side effects, and how people feel after taking it,” according to Pfizer documents cited by the British news outlet. The next phase will include multiple doses while the third will look into the influence of eating food at the same time.
For that part, participants could receive instructions such as to consume a high-fat breakfast of “two eggs fried in butter, two strips of pork bacon, two slices of toast with butter, 4 oz. of hash brown potatoes, and 8 oz. of whole milk,” all of which must be consumed in 20 minutes.
Volunteers have been warned that the drug has so far only been tested on animals, according to the Pfizer documents.
One of the documents cautions: “The safety of the study drug has been studied in animals. In these animal studies, no significant risks or safety events of concern were identified, and the study drug did not cause side-effects at any of the dose levels that will be used in clinical studies.”
Should the trials show no side effects, the drug could then go on to be tested on those who have been exposed to the coronavirus.
At the heart of the research is a man-made anti-viral molecule, PF 07321332, a protease inhibitor, which prevents the virus from reproducing in the nose, throat and lungs. Protease inhibitors are a key part of the treatment for HIV patients, though the drugs can have long-term side effects.
The ties to HIV will also be examined in the trials, with participants given doses of ritonavir, an antiviral drug used in the treatment of HIV that will help increase the amount of PF-07321332 in the participants’ blood.
Mikael Dolsten, chief scientific officer and president of worldwide research at Pfizer, said in an official statement last month that the molecule was designed “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.”
Ward, meanwhile, cautioned that even if successful, the drug would need to be fully developed and ready for public use at a reasonable price while the coronavirus is still a significant health threat.
It is, she said, a “race against time.”
Pfizer, together with its partner BioNTech, has already produced a COVID-19 vaccine that has proved to be over 95 percent effective and has been at the center of Israel’s mass inoculation drive. So far, over half of Israel’s population have received both required doses of the vaccine, making the Jewish state a world leader in per capita inoculations.