A day after the announcement by Johnson & Johnson that they were pausing their high-profile trial of its experimental coronavirus vaccine – a further study has now been put on hold – the announcement comes from Eli Lilly who are trialling an antibody drug.
On Tuesday, Lilly said enrolment in a trial of its monoclonal antibody treatment sponsored by the National Institutes of Health (NIH/Anthony Fauci) had been paused due to a potential safety concern.
The Eli Lilly trial was designed to test the benefits of the antibody therapy on hundreds of people hospitalized with Covid-19, compared with a placebo. All of the study participants also received another experimental drug, Remdesivir, which has become commonly used to treat coronavirus patients. It is unclear exactly what safety issues prompted the pause.
The new study is one of four ongoing or planned trials in the National Institutes of Health’s. Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, a public-private partnership to speed development of the most promising treatments and vaccine candidates. It is also receiving support through “Operation Warp Speed) the US government’s multi-agency effort to develop, manufacture and distribute medical countermeasures to fight COVID-19.
Opportunity
Through the ACTIV initiative, NIH is pursuing 4 fast-track focus areas most ripe for opportunity, each of which is led by a working group of senior scientists representing government, industry, non-profit, philanthropic and academic organisations.
This government-sponsored clinical trial is similar to the treatment undertaken by US President Donald Trump. President Trump touted the Lilly drug, along with the antibody treatment from Regeneron as tantamount to a cure in a video that he posted.
The Indianapolis-based drug maker did not comment on the implications for the paused trial, called ACTIV-3, which is testing the treatment on COVID-19 patients who require hospitalization, or on its other ongoing trials. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.
Lilly began its ACTIV-3 trial in August and is aiming to recruit 10,000 patients primarily in the United States. There are 51 sites for this study
While the ACTIV-3 trial remains in limbo, the company said on Wednesday that the Independent Data Safety Monitoring Board that recommended the pause hasn’t called for enrolment to be paused in another government-run trial it is overseeing, known as ACTIV-2.
The treatment is being developed together with Canadian biotech AbCellera.
My Thoughts
Just last week, Trump promised to get both Regeneron and Eli Lilly’s drug approved “urgently”
Was the halting of this treatment a political move? – it certainly bears all the hallmarks of President Trump’s previous “game changer” Hydroxychloroquine which was also removed from the trials.
But of course that would be a “tin foil hat” conspiracy theory wouldn’t it?
https://www.nih.gov/research-training/medical-research-initiatives/activ
I wrote my first article for Unity News Network on 30th December 2019, and I have been writing ever since – my library is now well in excess of 200 articles.
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