Texas A&M Chemist Cautiously Optimistic Regarding Remdesivir Clinical Trial Results
As a chemical biologist at Texas A&M University, Wenshe Ray Liu has a vested interest in preliminary results from a University of Chicago clinical trial using the experimental drug remdesivir to treat patients suffering from COVID-19.
Liu was the first person to identify the Gilead Sciences-developed antiviral as the only viable medicine for treating COVID-19 in a January research study. At the time, he believed so strongly in its singular effectiveness that he refocused his entire research group from cancer to COVID-19, challenging them to find additional drugs capable of combatting the novel coronavirus pandemic then rapidly spreading across the globe.
Liu describes the early reports out of Chicago as “quite exciting” and says he remains cautiously optimistic, given the nontraditional nature of the trial, which didn’t include a control group. STAT News reported the findings last week.
“There were 125 patients — 113 with severe symptoms, and 111 of them survived,” Liu said. “Despite the fact it wasn’t a rigorous trial, I think it’s fair to say remdesivir can help with severe symptoms. Considering fatalities are somewhere around 25 percent otherwise for patients with severe symptoms, it’s a significant improvement, no question about it.”
In Liu’s view, one of the study’s biggest revelations has less to do with solving an international medical crisis than one of conscience.
“In a double blind trial, you would have had another group of 125 patients who would have been given a placebo,” Liu said. “However, that would create a major ethical issue, because if you give a placebo, you’re effectively watching 125 patients die. The FDA needs to rewrite some of their guidelines. You cannot follow traditional design in situations like a global pandemic. It’s something they need to solve.”
Liu notes the FDA already has approved orphan drug status for remdesivir, clearing it for limited use to treat roughly 200,000 patients worldwide. He remains hopeful the FDA will use a different route to fast-track it for approval on a broader scale.
“The FDA approving orphan drug status is a big step, because it gives Gilead some degree of competitive protection, but with two million-plus patients to date, we should be encouraging all drug companies worldwide to explore all viable alternatives,” he said.
In recent months, Liu says there were high hopes for the malaria drug hydroxychloroquine as another possible treatment after a French research group released a paper describing good results. However, that paper was retracted, and there were reports that it wasn’t as effective as reported. Among other complications, Liu says the drug has a high toxicity and causes other adverse side effects.
“I think remdesivir is the way to go and the only option we have right now,” he added.
Meanwhile on the second floor of the Texas A&M Chemistry Building, the Liu Laboratory persists in its efforts to find additional safe alternatives, focusing primarily on small-molecule-based therapeutics in joint work with Texas A&M biochemist Thomas Meek. One compound they are testing has been found to be very potent and effective at eradicating the virus from within cells.
Liu says he hopes to get a promising therapeutic approved for their own potential clinical trials through the Texas Medical Center-affiliated Houston Methodist Hospital and is requesting it be free of charge for at least a year.
“Although it’s still very early, we have huge hopes for this particular small molecule,” Liu said. “But it’s not going to be a quick solution. Regardless of the therapeutic in question, it takes time to make sure the compound is stable enough within the human body and not toxic. In addition, you have to determine the optimum delivery method, such as IV injection or pill form. There are many details to be worked out, but for now, we’re concentrating on perfecting the chemistry.”
As for that January paper, Liu describes it as the most impactful publication thus far in his young career. In addition to ChemRxiv, it was published in the Germany-based journal ChemBioChem and picked up by many Chinese media outlets along with Chemistry World.
“After the paper was published, I received several emails, asking about possible collaborations,” Liu said. “The only trouble there is, most U.S. labs are closed.”
As the U.S. and other countries begin contemplating steps to resume life as the world knew it before COVID-19, Liu says he hopes to see significant changes in two areas: the manufacturing industry and biomedical research.
“In manufacturing, we’re often heavily reliant on a single source for many items, from medical supplies to pharmaceutical and research materials, and that’s problematic,” Liu said. “We also need to rethink how we do biomedical research. We need to put more money toward funding for cures.”