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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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The Race to Respond, CBS This Morning, 5-Aug-2020

NIH to test COVID-19 antibodies in hospitalized patients-starting with Eli Lilly’s, Fierce Biotech, 5-Aug-2020

Lilly Targets Mild Covid-19 Cases With New Antibody Study, Bloomberg Law, 4-Aug-2020

NIH: Enrollment Starts for Two Trials Testing Possible Coronavirus Antibody Drug, U.S. News and World Report, 4-Aug-2020

U.S. to Launch Covid-19 Drug Research Starting With Eli Lilly Treatment, The Wall Street Journal, 4-Aug-2020

Eli Lilly begins COVID-19 prevention trial in nursing homes, PMLive, 4-Aug-2020

Covid-19 treatment update: US drugmaker starts phase 3 trial for Covid-19 antibody treatment, Healthworld (Economic Times), 4-Aug-2020

Trial Investigating COVID-19 Therapy in Long-Term Care Facilities Begins, Monthly Prescribing Reference, 4-Aug-2020

US launches advanced trials of antibody treatment for Covid-19 patients, CNN, 4-Aug-2020

Racing to a Cure, CBS Evening News, 4-Aug-2020

Eli Lilly is testing a way to prevent covid-19 that’s not a vaccine, MIT Technology Review, 3-Aug-2020

Eli Lilly is using mobile labs to study if its antibody drug can prevent Covid-19 in nursing homes, CNBC, 3-Aug-2020

COVID's Growing Crisis, ABC World News Tonight, 3-Aug-2020

Eli Lilly launches late-stage antibody treatment trial to be tested in US nursing homes, ABC News, 3-Aug-2020

Nursing home leaders hope new antibody trials will put them on 'offense' against COVID-19, ABC News, 3-Aug-2020

Eli Lilly’s Virus Antibody Drug Starts Testing in Nursing Homes, Bloomberg, 3-Aug-2020

Lilly starts phase 3 test of COVID-19 antibody in nursing homes, Fierce Biotech, 3-Aug-2020

Lilly to test COVID-19 antibody drug in unorthodox nursing home study, BioPharma Dive, 3-Aug-2020

Covid-19 roundup: Eli Lilly retrofits RVs for first-of-its-kind antibody trial with NIH; Amgen, AbbVie, Takeda team on a drug, Endpoints News, 3-Aug-2020

Eli Lilly to test COVID-19 antibody drug in nursing homes, Becker’s Hospital Review, 3-Aug-2020

Eli Lilly Launches COVID-19 Clinical Trial in Nursing Homes with Symphony as Partner, Skilled Nursing News, 3-Aug-2020

Eli Lilly begins stage-three trial for COVID-19 antiviral drug, United Press International, 3-Aug-2020

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

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

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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

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

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

Tags: COVID-19, Clinical Research,

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