[MAGNIFYING GLASS] Remdesivir to the rescue? Not so fast, as approvals for the treatment may take timeGreat news about a recent study on a possible Covid-19 treatment needs to be greeted with muted cheer.
In two trials of Gilead Sciences’ remdesivir on a total of 125 patients, of which 113 showed severe symptoms, most of the patients were discharged. Two patients died.
Following the positive early outcome of the Phase 3 clinical trials at the University of Chicago Medical Center, shares of Foster City, California’s Gilead Sciences rose 9.73 percent Friday on the Nasdaq.
At the moment, Gilead Sciences is directly running two clinical trials utilizing the experimental drug - which was originally developed for treating Ebola - for the possible treatment of Covid-19. More remdesivir studies are underway and being run by others.
Two remdesivir trials in China were suspended and terminated from lack of eligible patients.
Remdesivir studies are also being done in Korea. According to the Korea Centers for Disease Control and Prevention, two Phase 3 clinical trials on remdesivir are underway in the country.
One of them is run by Gilead Sciences itself in coordination with three hospitals, and the other is run jointly by the U.S. National Institutes of Health and Seoul National University Hospital. Results of those trials are expected to be out by late next month.
Even if the news is also positive, investors and others still need to remain cautious.
Once a drug has the approval of the regulator, the potential for harm is much greater.
The treatment would still have to clear a number of hurdles to actually reach those in dire need.
The Ministry of Food and Drug Safety promised to shorten its review timeline to as little as 7 days for clinical trials related to Covid-19 treatments, but the same promise wasn’t made in granting approvals.
There’s a reason for the ministry to be conservative in this respect. Clinical trials are trials, and there’s an element of experimentation. It means that a drug candidate can be tested even if it can’t be completely assured that it is safe and effective.
Approvals for use are a whole different matter. Once a drug is on the market with the stamp of approval from the regulator, the potential for harm is much greater.
It is safe to say that the pace of approvals achieved in the review Covid-19 diagnostic kits in Korea won’t be achieved in reviewing approvals for coronavirus treatments. Kits aren’t drugs.
Statistics suggest patience. According to the M.I.T. Laboratory for Financial Engineering, only 13.8 percent of drug programs make it from the start of clinical trials to actual approval by health authorities.
Some organizations say that the odds may be as low as one in 1,000.
The Chicago study is particularly insignificant in the scheme of things, and even Gilead Sciences said that after its shares leaped.
“We understand the urgent need for a Covid-19 treatment and the resulting interest in data on our investigational antiviral drug remdesivir,” Gilead Sciences said in a statement.
“The totality of the data need to be analyzed in order to draw any conclusions from the trial. Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for Covid-19.”
The timeline is particularly problematic as Korea has been out of the woods, as a country, for some time. Other places may need the treatment, but Korea has beaten the disease down to just a few cases a day with testing and containment, and it could probably do the same if the virus were to return.
Gilead Sciences is manufacturing thousands of remdesivir doses for compassionate use globally, and its Korean unit is in talks with the Ministry of Food and Drug Safety to nail down the volume, but chances are high that not much of it will reach Korea.
Korea also has local companies working on their own treatments - by big names like Celltrion and SK Bioscience - and it is possible that progress will be made.
This is important for Korea and for the world, but any treatment will also probably be slow in coming to the market. The hurdles will be just as high as for others, and the wait just as long.
BY KO JUN-TAE [email@example.com]