Safety concerns pause trials of Vancouver-linked COVID-19 treatment

The federal government has earmarked $175 million for Vancouver-based AbCellera in its fight against COVID-19 | B.C. Centre for Disease Control

What happened: Trials halted for COVID-19 treatment linked to B.C. biotech

Why it matters: Federal government had earmarked $175 million to support development of therapeutic antibodies being used in trials

Trials of a COVID-19 treatment linked to a Vancouver-based biotech have been put on hold by the U.S.-based National Institutes of Health (NIH) over safety concerns.

American pharmaceutical giant Eli Lilly and Co. (NYSE:LLY) confirmed to broadcaster CNBC Tuesday (October 14) that concerns are directed only at its ACTIV-3 trial.

Lilly and Vancouver-based biotech AbCellera Biologics Inc. had collaborated on an antibody treatment known as LY-CoV555.

LY-CoV555 was being tested in two trials: The NIH-led ACTIV-2 and ACTIV-3 studies of ambulatory and hospitalized COVID-19 patients.

“Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” Lilly spokeswoman Molly McCully told CNBC. 

“Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

ACTIV-2 trials will continue.

Treatments using LY-CoV555 had been producing results that appeared effective in recent weeks.

Last month Lilly released proof-of-concept data showing reduced hospitalization rates for patients treated with the antibody.

The pharmaceutical company reported the rate of hospitalizations and emergency room visits for those treated with LY-CoV555 was 1.7% compared with 6% for those treated with a placebo.

Lilly said this represents a 72% risk reduction, while the treatment was “well-tolerated, with no drug-related serious adverse events reported” among those taking LY-CoV555.

In May, Ottawa earmarked $175 million for AbCellera to pursue the development, manufacturing and distribution of therapeutic antibodies.

This came after AbCellera and Lilly announced in April a partnership to develop a new drug for the treatment and prevention of the COVID-19 virus, with Lilly tapping the Vancouver biotech’s platform to zero in on antibodies generated in a natural immune response to the novel coronavirus.

LY-CoV555 wouldn’t be administered to the general population, but to those already infected with COVID-19 and who require treatment.

The LY-CoV555 antibody treatment was developed over three months with co-operation from Vaccine Research Center at the National Institute of Allergy and Infectious Diseases after the organizations identified it from a blood sample taken from one of the first U.S. patients to recover from the coronavirus. 

Lilly describes LY-CoV555 as the first potential new medicine specifically designed to combat the virus that causes COVID-19.

The first patients were dosed at medical centres in the U.S., including the NYU Grossman School of Medicine and L.A.’s Cedars-Sinai.

torton@biv.com

@reporton