Clinical testing underway for coronavirus drug developed by Foster City company

ByDavid Louie KGO logo

Friday, February 28, 2020

Testing underway for coronavirus drugs in US, China

Companies around the world and in the Bay Area are creating and now testing drugs to treat the widespread novel coronavirus. Foster City-based company Gilead is moving forward with studies to test the drug's safety and efficacy.

SAN JOSE, Calif. (KGO) -- The spread of novel coronavirus has many people and countries on edge, looking for a drug to treat it or a vaccine to guard against it.

Trials are now underway in the U.S., China and possibly elsewhere.

One drug, an antiviral, is a product of Gilead, a company in the Bay Area.

The new drug remdesivir was originally developed as a treatment for Ebola and other viruses, but was given to an unknown number of patients in China with promising results.

Now, Foster City-based Gilead is moving ahead with two clinical studies to test the drug's safety and efficacy at differing dosages and durations.

No country has licensed or approved it for any use so far.

Another biotech company, Moderna, has also announced the release of a new vaccine to test on humans against coronavirus, but the key word is patience.

The FDA says the timeline to develop and approve a new drug typically is 9 1/2 to 14 years. Even when expedited, approval can take 5 1/2 to 11 years.

"To see a Phase three trial planned, designed, executed, run, analyzed in less than two years would be unusual," said biochemist Mark Schwartz. "Typically longer from complete start to complete end."

Schwartz is a biochemist who has been CEO of several biotech companies.

He says one of the challenges is finding willing test patients, including those who have not been given other drugs.

"If the spread of the disease continues to progress, the FDA may lower that concern over that if the drug shows efficacy and be willing to take patients that have been pre-treated with something else," he said.

The CEO of San Francisco's Kinsa, which uses artificial intelligence to track and predict the spread of flu, hopes the U.S. will look at other technologies.

While drugs are important, CEO Inder Singh said, "there also needs to be effort on protective mechanisms, detection mechanism, prediction mechanisms so we can say, 'hey, it is actually going to be bad or it's going to be worse in two weeks, or this locale's going to get hit,' or I can talk to a consumer within hours of their symptoms so we can help get them better."

The trial for Gilead's remdesivir will involve about 1,000 test patients.

With over 44,000 cases of coronavirus in China, it's possible China might expedite approval of the antiviral for its patients if early trial results show positive results and no side effects.

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