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Eli Lilly’s COVID-19 antibody trial paused due to safety issue

Company has voluntarily paused study amid safety review

Eli Lilly has voluntarily paused a clinical trial of its COVID-19 antibody treatment due to a potential safety concern, according to The New York Times.

The pause of the US National Institutes of Health (NIH) partnered study comes just a day after pharma giant Johnson & Johnson (J&J) said that it had also put a trial of its COVID-19 vaccine candidate on hold after a participant fell ill.

Lilly has been studying its antibody treatment as a potential treatment for patients hospitalised with COVID-19, as well as in a number of additional patient populations.

Earlier this month, the drugmaker said that it was seeking initial emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its LY-CoV555 antibody in high-risk patients who have recently been diagnosed with mild-to-moderate COVID-19.

This was due to the antibody treatment demonstrating positive results in an interim analysis, showing that the drug helped to reduce hospitalisation and accident and emergency visits for COVID-19 patients.

Lilly is also testing the antibody treatment as a preventative therapy for nursing home residents and workers who may have been exposed to the virus.

In a statement Molly McCully, a spokeswoman for Lilly, said: “Safety is of the utmost importance to Lilly […] Lilly is supportive of the decision by the independent Data and Safety Monitoring Board (DSMB) to cautiously ensure the safety of the patients participating in this study.”

Another COVID-19 vaccine developer, AstraZeneca, paused its phase 3 clinical trial in September after a patient in the UK-based study developed transverse myelitis, an inflammatory condition which affects the spinal cord.

According to Reuters, a NIH spokeswoman said the Lilly trial was paused when the DSMB found that the antibody-treated group showed a different ‘clinical status’ after five days of treatment compared to the placebo arm.

However, the NIH did not provide specific details regarding the exact nature of the concerns, adding that the safety board will review the data again on 26 October and then advise whether the NIH should resume the trial.

Until that point, researchers are still going to continue to collect data from participants who are already enrolled in the study.

Reuters also reported yesterday that FDA inspectors had discovered 'serious quality control issues' at a Lilly manufacturing plant in Branchburg, New Jersey last year.

The inspectors found last November that data was deleted from previous manufacturing processes, which resulted in an 'Official Action Indicated' notice being issued.

Lilly has since confirmed the OAI notice but said that the data deletions were unrelated to the COVID-19 antibody. The company added that it has launched a 'comprehensive remediation plan' and is also 'aggressively' working to address the issues raised in the inspection.

Article by
Lucy Parsons

14th October 2020

From: Research



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