Early Trial Results Show Antibody Treating Covid-19

Scanning electron microscope image of SARS-Cov-2 virus, in orange, emerging from cells (NIAID, Flickr)

16 Sept. 2020. First results from a clinical trial testing an experimental synthetic antibody, show patients receiving the therapy at a specific dosage, cleared their SARS-CoV-2 viruses within 11 days. The antibody, code-named LY-CoV555 is designed by Abcellera Biologics Inc. in Vancouver, British Columbia, and produced by Eli Lilly and Company in Indianapolis, Indiana.

The mid-stage clinical trial is testing LY-CoV555 as a treatment for individuals recently diagnosed with Covid-19 infections and mild to moderate symptoms. In addition to measuring clearance of SARS-CoV-2 viruses responsible for Covid-19 infections, the trial is tracking subsequent hospitalizations by trial participants, as well as adverse effects from the treatments.

LY-CoV555 is a neutralizing immunoglobulin G antibody designed to block the SARS-CoV-2 spike protein that penetrates and infects cells. AbCellera uses what it calls deep mining of B-cells from the immune system to discover antibodies for preventing and treating diseases caused by a range of viruses and bacteria. B-cells are white blood cells in the immune system that produce antibodies, proteins that directly attack invading pathogens, such as bacteria and parasites. The company’s antibody discovery process combines a number of technologies, beginning with single-cell screening with microfluidics, or lab-on-a-chip devices.

As reported by Science & Enterprise in March, AbCellera says it screened more than 5 million immune-system cells against a blood sample from one of the first people in the U.S. infected with the novel coronavirus, as it was called at the time. From this screening, the company says it identified some 500 unique human antibody sequences that respond to the SARS-CoV-2 virus. Lilly and AbCellera partnered with the Vaccine Research Center at National Institute of of Allergy and Infectious Diseases, or NIAID, part of National Institutes of Health, to identify the best-performing candidates.

Participants in the trial are randomly assigned to receive one of three dose levels of LY-CoV555 — 700, 2,800, or 7,000 milligrams — or a placebo. Participants receiving the 2,800 milligram dose cleared their SARS-CoV-2 viruses within the target of 11 days. In addition, only 1.7 percent of 302 participants receiving LY-CoV555 at any dose needed to visit an emergency room or require hospitalization, compared to 6 percent of 150 placebo recipients.  Even for those requiring hospitalization, none needed mechanical ventilation, and those receiving LY-CoV555 showed faster improvement in their symptoms.

Eli Lilly says LY-CoV555 was well-tolerated with no drug-related serious adverse effects. Adverse effects of any kind from the antibody were similar across the different dose levels and comparable to placebo recipients.

Daniel Skovronsky, Eli Lilly’s chief scientist, says in a company statement the early trial data “suggest that LY-CoV555, an antibody specifically directed against SARS-CoV-2, has a direct antiviral effect and may reduce Covid-related hospitalizations. The results reinforce our conviction that neutralizing antibodies can help in the fight against Covid-19.”

The clinical trial is enrolling 800 individuals with mild to moderate Covid-19 symptoms at 71 locations in the U.S. The study is also testing another antibody code-named LY-CoV016 in combination with LY-CoV555, compared to LY-CoV555 alone and placebo. Eli Lilly says LY-CoV016 binds to a different site in the SARS-Cov-2 spike region.

While the trial findings were released directly by Eli Lilly, the company says it plans to submit the data to a peer-reviewed journal.

More from Science & Enterprise:

• Small Antibody Shown to Block Covid-19 Infection
• Synthetic Antibodies Neutralize Covid-19 Virus Proteins
• Biotechs, Univ. Labs Partner on Covid-19 Combo Therapy
• NIH Begins Covid-19 Antibody Trials
• Trial Set for Covid-19 Antibodies in Long-Term Care

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