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Lilly’s COVID-19 Clinical Trials are Underway

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Editor’s note: Dan Skovronsky is the chief scientific officer and head of research and development at Eli Lilly and Company.

The rush to find effective medications to treat and potentially prevent COVID-19 is on. In fact, it has been on for several months now, since COVID-19 was first identified. And this rush is sparking unprecedented global medical and scientific collaboration and partnership.

As researchers, we aren’t racing against each other. We’re racing against the death toll from the virus. Ultimately, I hope that there will be multiple successful treatment options for patients and their healthcare providers. But before new treatments can be used broadly, we need to demonstrate their safety and efficacy through clinical trials. Thanks to a common purpose and partnerships across government, industry, and academia, these studies are moving at an extraordinary pace and scale.

Earlier this month, Lilly began clinical trials to test two antibodies engineered from patients who had fought COVID-19 and recovered. Antibodies are produced by the immune system in response to bacteria, viruses, and other foreign invaders, and help the body neutralize and destroy these threats. However, it takes time for the body to produce its own antibodies, and we are testing whether administering an antibody engineered from a COVID-19 survivor can speed recovery, or maybe even prevent infection in the first place.

The science behind this approach is not new. In fact, the practice of using convalescent plasma, which is the liquid part of the blood that contains antibodies, to treat various medical conditions has been around for decades. However, because convalescent plasma must be obtained from individual donors, it cannot be scaled broadly and its effectiveness varies between individual donors. Thankfully, advances in biotechnology now allow us to quickly identify the superstar antibodies from patients who have recovered from COVID-19, and mass produce them in sophisticated bioreactors.

Multiple companies and universities are pursuing such antibodies, and several have been shown to have a neutralizing effect in laboratory studies — blocking the COVID-19 virus from infecting cultured cells and replicating. Recently, one was shown to rapidly reduce virus levels in infected animals, and to prevent infection in animals that were pretreated with the antibody.

Lilly is testing the safety and efficacy of three different antibodies in hundreds, perhaps thousands, of people over the next few weeks and months.

  • One antibody, currently designated as LY-CoV555, is being developed in partnership with Canadian biotech AbCellera and is being tested in patients with mild to moderate COVID-19.
  • A second antibody, designated as LY-CoV016, is being developed in partnership with drug maker Shanghai Junshi Biosciences and is currently being tested for safety in healthy volunteers.
  • A third potential antibody treatment acts on a different part of the virus and will most likely be tested in combination with one or both of the others.

These antibodies — once proven safe and effective - may provide a good option for medical care of COVID-19 patients by both treating active disease and potentially preventing new infections through passive immunity. It’s fascinating to look back at statements from Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, from a few years ago where he describes this exact scenario. (Take a moment to listen to this interview from the New England Journal of Medicine from 2018.)

In the long run, the better solution is to protect people with effective COVID-19 vaccines, once they are available, and reserve antibody treatments for people who have the disease, were recently exposed, or belong to a group that traditionally does not respond well to vaccination, like the elderly and those on medications to suppress their immune systems. But it will likely be some time before vaccines are available.

Let’s consider a scenario very much in the here and now:

Imagine you are an otherwise healthy individual, with a job that involves regular contact with other people. You wake up feeling unwell with a slight cough, sore throat, and headache. But you don’t feel all that sick, and even if you have COVID-19, you know you’ll mostly likely recover on your own. Still, there is a small chance you will need to be hospitalized, or even die from the disease. The reality is, we don’t know what causes some people to be more vulnerable than others. For this reason, it’s important to seek testing, speak with a healthcare professional, and avoid contact with others. But now you can do more than that; you can consider participating in clinical research. In doing so, you’ll help advance the body of scientific and medical knowledge, and may help us find the treatment we need. The rush is on, but we need your help.

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Bibliography

Inside Eli Lilly's Race For A Coronavirus Therapy, Indianapolis Monthly, 19-Jun-2020

Coronavirus: Cedars-Sinai researchers testing new anti-viral medication designed specifically for COVID, ABC7 Los Angeles (KABC), 18-Jun-2020

Monoclonal Antibodies for Prevention and Treatment of COVID-19, Journal of the American Medical Association (JAMA), 15-June-2020

Eli Lilly Testing Antibody Treatment For COVID-19 Patients, Fox 5 Good Day New York, 11-Jun-2020

Exclusive: Lilly COVID-19 treatment could be authorized for use as soon as September - chief scientist, Reuters, 10-June-2020

Lilly gets a 2nd COVID-19 antibody into clinical trials with Junshi's help, BiopharmaDive, 8-Jun-2020

Biopharma Update on the Novel Coronavirus: June 8, BioSpace, 8-Jun-2020

Eli Lilly, Junshi Biosciences To Conduct Phase 1 Study In China And US For SARS-CoV-2 Antibody, RTT News, 8-Jun-2020

Eli Lilly announces start of first phase for second potential COVID-19 antibody treatment, CBS 4 Indiana, 8-Jun-2020

Eli Lilly Kicks Off a Clinical Trial for a Second COVID-19 Antibody Treatment, The Motley Fool (Also seen in Nasdaq), 8-Jun-2020

Lilly starts second COVID-19 antibody test with partner Junshi Biosciences, eyes combo trials, FierceBiotech, 8-Jun-2020

Telemundo Interview with Dan Skovronsky, Telemundo Un Nuevo Día, 5-Jun-2020

Eli Lilly Tests New COVID-19 Antibody Drug – Interview with Ajay Nirula, HealthCall Live, 5-Jun-2020

First Antibody Trial Launched in COVID-19 Patients, The Scientist, 2-Jun-2020

Eli Lilly Announces World’s First Potential COVID-19 Antibody Treatment, WFYI, 2-Jun-2020

First coronavirus antibody treatment study in humans begins in U.S. hospitals, Boston Herald, 2-Jun-2020

New Human Trials of COVID-19 Antibody Treatment, WebMD, 1-Jun-2020

First human trial of antibody treatment for COVID-19 begins, KTLA 5, 1-Jun-2020 (Variations of this story have appeared in 103 outlets across the globe.)

Eli Lilly launches first human trial of experimental antibody COVID-19 treatment derived from blood of survivor that works by 'neutralizing' the virus, Daily Mail, 1-Jun-2020

Tags: COVID-19, Clinical Research,

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