China researchers tout in vitro data for Gilead's antiviral against Wuhan virus — which they are trying to patent
There’s no definitive proof yet that Gilead’s remdesivir works as a treatment for 2019-nCov, but researchers in China clearly consider it promising enough to have applied for a patent on its use to combat the coronavirus virus outbreak stemming from Wuhan.
Amid worldwide vigilance over what many fear is becoming a pandemic, scientists from the Wuhan Institute of Virology and National Engineering Research Center for the Emergency Drug said they have tested a total of seven drugs in vitro — and found remdesivir and the malaria treatment chloroquine most effective against the novel coronavirus.
In a statement, the institutions also disclosed that they filed a patent application on January 21, days before Gilead first announced it’s dusting off the nucleoside analog — which failed to make the cut as an Ebola drug — to test against the new virus.
While experts have indicated that a patent is unlikely to be granted, the move highlights growing confidence in remdesivir in the midst of a global race to hunt antibodies and therapies for 2019-nCoV, for which there is no approved treatment. The highly contagious virus has killed more than 490, mostly in China.
The update also comes as the FDA issued its first Emergency Use Authorization (EUA) since the Department of Health and Human Services declared a public health emergency in the US on January 31. The EUA means that the 2019-nCoV diagnostic panel that’s been in use at CDC labs can now be used at any CDC-qualified lab across the country.
Gilead — which has been in a patent dispute with the US government over its HIV franchise — didn’t answer directly whether it knew about the patent filing before the announcement or what it thought about the Chinese researchers’ grounds.
Gilead invented remdesivir and has patented it in China, including filing patent applications for use on coronaviruses. We are aware of reports of the Wuhan Institute for Virology’s patent application. Our focus at this time, is on rapidly determining the potential for remdesivir as a treatment for 2019-nCoV and accelerating manufacturing in anticipation of potential future supply needs.
After US doctors reported using remdesivir as part of the regimen for the first domestic case of 2019-nCoV, Gilead said it’s working with Chinese authorities to start a randomized controlled trial.
Nine trials are already underway to evaluate different combinations of already approved antivirals and corticosteroids, BioCentury noted, including HIV drugs such as AbbVie’s Kaletra/Aluvia and Gilead’s Descovy.
Remdesivir, on the other hand, is an experimental compound that’s been tested in human trials. In a Q4 earnings call, Gilead CEO Daniel O’Day indicated that it may be deployed as an emergency treatment. In response to a question about manufacturing preparations in the event that they need to scale up production quickly, he had this to report:
In terms of manufacturing, our team has really been working night and day, it’s been very impressive to watch this team over the past couple of weeks really ramp up to the extent that we can. Our capacity is going up every day. We’re looking at all the options we have expecting to be prepared for what may come.
Obviously we are waiting for data, both in vitro and then in people to ensure that the drug actually works. And it’s important just for everyone to keep that in mind that this is still investigational and we are still waiting for more data to know. But at risk, we are investing pretty heavily to make sure that we’re prepared as best as we can.
Around the same time, some in vitro data were being published on Nature as a letter to the editor.
“Notably, two compounds remdesivir (EC50 = 0.77 μM; CC50 > 100 μM; SI > 129.87) and chloroquine (EC50 = 1.13 μM; CC50 > 100 μM, SI > 88.50) potently blocked virus infection at low-micromolar concentration and showed high SI,” they wrote.
Given its potential, the Wuhan Institute of Virology said in a statement, it’s applied for a patent in China and plans to distribute to other countries via the Patent Cooperation Treaty. But should “the relevant overseas company” be willing to contribute to the outbreak control, they would temporarily suspend exercise of their patent rights.
But experts interviewed by local media point out that the application may not go through. Not only does Gilead hold the foundational patent to the drug, but it also applied for one to cover remdesivir’s use in coronaviruses back in 2016 — which didn’t specify but could arguably include this new strain.