A prominent executive of the American drug giant behind a drug touted as an effective treatment for COVID-19 urged caution as to its effectiveness.
In the past 24 hours, Wall Street has been delighted with a report that Gilead Sciences, the California-based drug maker, has found an effective treatment for coronavirus.
Shares of the company, best known for its treatments for HIV and hepatitis B, climbed 16% at one point following a report that patients COVID-19 who were treated with the drug, remdesivir, experienced rapid recovery.
Stat medical news website reported that patients at a University of Chicago hospital had received treatment with remdesivir.
He said 125 patients with COVID-19, including 113 with severe form of the virus, participated in two “phase 3” clinical trials.
Phase 3 trials take place in the later stages of drug development and are the last hurdle a product must overcome before its manufacturer approaches a regulatory body for approval.
The website reported that, although two died, most patients treated with remdesivir quickly recovered and were discharged.
But Hilary Hutton-Squire, managing director and vice president of Gilead Sciences in the UK and Ireland, told Sky News that there is still a long way to go.
She said: “We are in the midst of an unprecedented global crisis and it is clear that people would like to hear positive news, but we must also be very balanced in our approach.
“What we saw was a speech at the hospital about their experience … we really need to look at the results of this trial, and in fact other trials going on right now, in their entirety before we can really draw any conclusions on the efficacy and safety of remdesivir.
“So our goal is to continue with these very large clinical studies and find answers for people as soon as possible. “
She said about six large clinical studies are underway worldwide involving thousands of patients, including more than 100 enrolled in the UK, with results expected in late April and early May.
She added, “In the meantime, we are doing everything we can to make sure that if the results are positive, we are ready to distribute this medication to these patients worldwide as quickly as possible and have an impact on this pandemic. “
Some health and science professionals have expressed skepticism about the trials because so few patients have been tested to date and because the results of the trial have not been reviewed. peer review.
It was also pointed out that, in the Chicago trials, no placebo was used against which the effectiveness of remdesivir could be measured.
In addition, it was a so-called “open” trial in which patients knew they were receiving treatment and there were also precautions that none of the patients in the Chicago trial was ventilated.
Acknowledging this, Hutton-Squire said the UK trials would include patients with different “severity levels”, including some patients on respirators and some who had just been hospitalized.
She continued, “We have to be careful [in our interpretation]… It’s going to be one of those things where we have a lot of puzzle pieces and we have to put them together in the coming weeks to really understand what we have here and what we need to do with it to help patients. “
Hutton-Squire, who previously helped deliver hepatitis treatment through the NHS, said that remdesivir was originally designed to fight the coronavirus.
It was then reused to treat the Ebola virus, as it ravaged West Africa between 2013 and 2016, before “closing the loop”.
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Before this particular outbreak, she said, the drug was considered to be a treatment for a variety of illnesses, including coronaviruses.
“This is why, when we heard about this virus last January, we thought it was really important to go as quickly as possible to understand what the role of remdesivir for COVID-19 could be.”
She said Gilead is currently investing very heavily in manufacturing.
Hutton-Squire added, “This is a drug that generally takes up to a year to manufacture, from start to finish, we have tried to reduce this process to about six months and we work with hundreds of around the world to help us get our supplies of raw materials … so that we are ready to treat as many patients as possible, as quickly as possible, if the results of the trials are positive. “
But she insisted that this increase in manufacturing capacity should not be taken as a sign that the tests would certainly come back with a positive result.
She said, “It’s a sense of responsibility, to be honest.
“When we looked at this in January, we knew it would be one of the most promising drugs we looked at, because it had previous promising data on SARS (severe acute respiratory syndrome) and MERS (respiratory syndrome). Middle East). ).
“We had reasons … to go as fast as possible and, because of the turnaround time, there would be no point in doing a clinical research load and then starting manufacturing further down the line.
“We have to do it in parallel, and do it at risk, to have the potential impact that the drug could have if it works. “
“So we had to work as quickly as possible. “
She said she was speaking closely to the British government and praised the regulator, the Medicines and Health Products Regulatory Agency (MHRA), for “pragmatism and speed of travel” in helping Gilead launch the studies In progress.
The company has promised to make 1.5 million vials of the finished product available to health agencies around the world if the product is successfully launched.