Indiana could received its first supply of coronavirus vaccine soon, federal health officials say. However, there are still many questions about the vaccine.
The past year has been busy — and productive — for Eli Lilly and Co. In just eight months the Indianapolis drugmaker identified two treatments, one already on the market, for the virus that has claimed the lives of more than 250,000 Americans.
Usually drug trials take years, not months, to complete, but the deadly new pathogen has fast-tracked scientific research like never before.
Last week a Lilly drug for rheumatoid arthritis earned emergency use authorization for use in treating hospitalized COVID-19 patients in concert with a non-Lilly therapy. Earlier this month the Food and Drug Administration gave a similar nod to a new therapy developed since the pandemic began.
“A process that normally takes five to 10 years, we did that in about as many months,” Dr. Daniel Skovronsky, Lilly’s senior vice president and chief scientific officer, said in an interview with IndyStar earlier this week. “We moved with that speed because of an incredible sense of urgency.”
Much attention has swirled around the search for a vaccine, with two promising candidates expected to seek government approval before the end of the year and a third not far behind.
From the beginning, though, Lilly decided it would not join that race but would instead concentrate on therapeutics, Skovronsky said. The company took a two-pronged approach, looking at whether any of its already-approved drugs could help treat coronavirus and exploring potential new therapies.
“We asked ourselves what can Lilly do. We don’t make vaccines,” Skovronsky said. “We said we could make therapies. We’re a company that makes medicine.”
Lilly, however, early on recognized that it also could help the state with diagnostics, an area sorely lacking in the early days of the pandemic. The company set up a drive-thru testing site at is downtown headquarters for essential workers and those at high risk. Over time, Lilly worked with the state to help other labs enter the coronavirus testing arena. Now, the company restricts its coronavirus testing to samples from its clinical trials and its own employees.
Those clinical trials have yielded critical insights into how COVID-19 operates, shedding light on the fact that for many whom the virus affects most severely, it appears to be a two-phased disease. The first phase consists of an acute illness. In the second phase, the patient’s own immune system overreacts, leading to potentially serious illness.
“In those patients it’s not like fighting the virus; it’s about dialing in your own immune system so it’s not too rampant,” Skovronsky said.
As some researchers started exploring whether other drugs, already in circulation, might help tame that response, other scientists began studying samples from patients who had recovered from COVID-19 to find weapons against the SARS-CoV-2 virus, harnessing the remarkable human immune system.
Whenever our bodies encounter new pathogens they develop thousands and thousands of antibodies, which aim to neutralize those germs. These antibodies differ from person to person. So the Lilly scientists sought to discover antibodies that already had proven they worked.
Lilly worked with a Canadian company to isolate antibodies from one of the first people in the Pacific Northwest to recover. Another team worked with a group from the Chinese Academy of Sciences, studying a sample from a recovered patient in that country.
Both teams searched for antibodies that would work against the coronavirus’s signature spike protein, which allows it to enter the host’s cells and reproduce. They hoped to produce a monoclonal antibody treatment from their studies.
From the start, researchers had no way of knowing whether the best antibodies would be among the first few that they isolated. As it turned out, they hit gold with bamlanivimab, an antibody isolated from the American patient that binds to the virus, disarming it.
“There’s certainly an element of good fortune here that bamlanivimib is such a good antibody,” Skovronsky said. “That saved us months.”
But the researchers also realized that viruses can be canny and evolve to evade what once worked. So they also looked at how the Chinese patient had responded and isolated a different antibody from that sample.
Earlier this month the company received emergency use authorization for bamlanivimib, delivered through an infusion. Now, Lilly has a trial underway looking at whether combining the two antibodies would lead to an even better therapy that decreases viral load and symptoms.
During the bamlanivimib trial, patients received the infusion on average four and a half days after symptoms began. The FDA approved the therapy for high risk patients up to 10 days after symptom onset. Eligible patients include those over age 65, those who are obese or who have other chronic medical conditions.
“With drugs like this, it’s logical that the sooner the better,” Skovronsky said. “Once they’re in the hospital, it’s too late.”
The trial showed this helped prevent hospitalizations. Now the challenge will become finding ways to set up infusion centers where people infected with the coronavirus can safely receive the one-time infusion.
Bamlanivimib did not significantly change the course of illness for people already sick enough to be in the hospital, a Lilly trial found.
Lilly scientists had more success with a drug already approved for use with autoimmune diseases, baricitinib. A trial done in conjunction with the National Institutes of Health showed that when used in conjunction with remdesivir, hospitalized patients recovered faster than if they had just been given remdesivir alone.
Now Lilly is looking into whether baricitinib on its own may have an effect for hospitalized patients around the world. As the drug is easy to deliver — it’s a pill rather than an infusion like remdesivir — and available, that could prove useful in countries where it may be more difficult to obtain and administer remdesivir, Skovronsky said.
Not every investigation, however, yielded success. Another experimental medicine that the company had been testing for cancer performed poorly in a small trial of hospitalized patients.
Overall, the company views the past year as a success and may even look toward it for guidance in the future for developing drugs for other conditions from cancer to heart disease to diabetes, Skovronsky said.
“I think there’s a way to do drug development faster,” he said. “Maybe that’s the silver lining of this horrible disease, that we come out of this stronger and re-energized.”
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