Eli Lilly Pauses Antibody Drug Trial, Trump Called it COVID 'Cure'
A similar antibody drug treatment was given to US President Donald Trump after he tested positive for COVID.
The trials for antibody treatment from Regeneron Pharmaceuticals Inc, that was touted as a cure by US President Donald Trump, have been put on temporary hold.
Lilly had sought emergency use authorisation (EUA) for the antibody drug, LY-CoV555 last month.
This follows just a day after Johnson & Johnson paused it's large phase 3 trials for a COVID-19 vaccine, after a participant fell ill. J&J has not shared if the participant was given placebo or the vaccine and it hasn't shared details of the type of illness.
And that followed AstraZeneca-Oxford's pause on its COVID-19 trial in September. While the US trial remains on hold, they have resumed in other regions. It was the first to go into Phase 3 human trials; the phase 1/2 preliminary results have largely been promising, generating both antibody and T Cell response in participants.
In an email statement to Reuters, Lilly spokesperson Molly McCully said, "Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment. Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”
Pausing Trials Not Uncommon, Essential
It's important to note that pausing trials to go through safety data is common and essential aspect of clinical trials. Virologists say it's a good thing trials have been paused as letting them continue under pressure at breakneck speed can create a sense of vaccine doubt and raise questions on the efficacy.
Dr Shaheed Jameel had said pausing trials is also not uncommon, saying, "The good thing is that there is a system in place to recognise these adverse events and address them. This is good and will build confidence in the trials."
Dr Giridhar Babu, a Bengaluru-based epidemiologist also agreed with Dr Jameel. "All ongoing vaccine trials are regulated by international standards. Every minor or major incident has to be reported to a committee, which is the Data Safety Monitoring Board. The decision to halt is with the board. This is something that is common in all vaccine trials," he says, adding,
The ACTIV-3 trial began in August with the aim to recruit 10,000 patients.
The trial compares Lily's antibody drug along with remdesivir, with those who receive remdesivir alone.
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